Quorum defines a study as single site or central based upon with whom we communicate.

Single site: Quorum communicates directly with the site only. In this case, Quorum is not the central IRB for the study but the site has chosen Quorum as their IRB.

Central: Quorum communicates with the sponsor/CRO, protocol level decisions are made by the sponsor/CRO on behalf of site(s). In this case, Quorum is the designated central IRB for the study.

If the single site option is chosen:

• Information will only be released to the site.
• The site is responsible for safety reporting (please see more information on this below).
• The sponsor is not able to submit on behalf of all sites in a multiple single site study.
• It is more costly to submit multiple single sites under the same protocol then to submit the study as a central study.

Participating in research is a personal decision. You should read the consent from thoroughly and weigh the personal risks and benefits for participating in a research study. If you feel that you need assistance in making a decision, Quorum encourages potential study participants to talk to study staff, their personal doctor, family, friends and /or search the internet for information that might help you make a decision that is right for you.

Quorum’s phone number appears in all clinical research study informed consent forms that it approves. If you have specific questions about the research study you are in, you may find an answer by reading the consent form for the study or by asking your clinical investigator or a study staff member. Quorum may be able to answer general questions about the study or your rights as a research participant.

To contact Quorum, call 888-776-9115 (toll free) Monday through Friday, 8:00am-5:00pm Pacific Time and request to speak with a Research Participant Liaison. Please have your most recent consent form on hand when you call.

• To receive full information about the study as set forth in the signed informed consent form
• To decide not to participate or to withdraw at any time without penalty or loss of benefits to which the research participant is entitled
• To refuse or question study tests or procedures which are not mentioned in the consent form you signed
• To withdraw from the study if new information becomes available about the study medication which makes you uncomfortable about participating
• To receive payment for participation as indicated in the consent form you signed. If you believe the information is unclear, you may ask the study site for further information or decide not to participate
• To receive reimbursement for or to receive at no cost study procedures/tests as indicated in the consent form you signed; if you believe the information is unclear, you may ask the study site for further information or decide not to participate
• To receive treatment/reimbursement for treatment for adverse events as indicated in the consent form you signed; if you believe the information is unclear, you may ask the study site for further information or decide not to participate
• To seek alternative treatment for your condition rather than participate in the study
• To continue with your current treatment plan rather than participate in the study
• To ask the study staff questions about the study, the results of your lab tests or other diagnostic procedures
• To have your personal information kept as confidential as possible as detailed in the consent form you signed; if the information is unclear, you may ask the study site for further information or decide not to participate
• To receive a copy of your signed consent form to take home with you

As a participant you have a right to decide not to participate or to withdraw at any time without penalty or loss of benefits to which you are entitled.

Please contact your study doctor at the phone number listed on the first page of your consent form. If this is an emergency situation, contact 911 and follow up with your study doctor as soon as possible. If you need to seek emergency treatment, take your informed consent document or other information about the study to the hospital, if it is practical.

Please contact Quorum Review at call 888-776-9115 and ask to speak with a Research Participant Liaison.

A clinical research study is a study involving people that seeks to answer a specific scientific or health question. The study may involve the testing of an unproven drug, an investigational medical device, a diagnostic tool, a food or drink, or an existing therapy used in a new but untested way to see if the product is helpful in preventing, diagnosing, or treating a disease or condition. The study may involve an existing product used in a way that was previously found to be safe and effective in order to learn more about the product’s safety. Or the study may involve only the collection of health information in order to study a health issue in the general population.

People who volunteer to participate in a study may be called human subjects, research participants, or another term that identifies their role as volunteers in a clinical research study.

The doctor or healthcare professional who conducts the clinical research study may be called a clinical investigator, principal investigator, or study doctor. It is important to remember that the role of a clinical investigator is very different from the role of the health care provider. While your health care provider is responsible for making health care decisions for you based upon your medical condition, a clinical investigator is conducting a research study and is responsible for carrying out the study as described in the study protocol or study plan. This means that while the clinical investigator is responsible for carrying out the study in a way that minimizes research participant risks and maximizes the study benefits, the clinical investigator is limited by the requirements of the study with regard to the treatment options that can be provided to you, the research participant. Therefore, if you volunteer to participate in a research study, it is important that you maintain contact with your primary health care provider (your regular doctor) and other specialists before, during, and after your participation in the study to make sure that you have the best information about your health care decisions and to make sure that other treatments or medications you are taking do not interfere with your ability to participate in the study.

The people who assist the clinical investigator are part of the research team or study staff and generally include other doctors, nurses, study coordinators, and other healthcare professionals.

Studies involving a product are generally paid for and supported by the company that developed the product. This company is called a sponsor. Some government agencies, such as the National Institutes of Health, also act as sponsors in funding clinical research.

Finally, studies that involve human subjects generally must be conducted under the oversight of an institutional review board (IRB) or research ethics board (REB) to confirm that the health, safety and welfare of the participants are adequately protected. See below for more information about IRBs and REBs.

The reasons for deciding to participate in a clinical research study are very personal, but we can describe some of the reasons that have been identified by research participants. Some people participate in clinical research studies in order to add to the understanding of the product, which may help others in the future. Others want the opportunity to possibly receive investigational products that are only available in a clinical research study. Still others, in exploring all their medical options, view the opportunity to participate in a clinical research study as a way to play an active role in their health care.

A clinical research study involving an investigational product is an experiment to test the safety and effectiveness of the product. As a result, there may be risks to your health if you decide to participate. The risks to your health will depend on the type of study and how much is already known about the product. The risks may be no more than an unpleasant side effect that goes away quickly, or they may lead to a life-threatening condition. The risk may be that the product is ineffective and does not help your condition. The clinical investigator or study staff member should talk to you about all the reasonably foreseeable risks of participating in the clinical research study.

While it may not be possible to eliminate all risks associated with participation in a clinical research study, steps should be taken in all such studies to reduce possible risks. These steps should include the development of a study protocol that explains exactly how the clinical investigator is to conduct the clinical research study, and review and approval of the study by an institutional review board.

Quorum provides review services in accordance with the ICH Guidelines for Good Clinical Practice. For research to be conducted in the U.S., Quorum applies the requirements for institutional review boards found in the U.S. Food and Drug Administration regulations (21 CFR Part 56) and the U.S. Department of Health and Human Services regulations (21 CFR Parts 50 & 56). For research to be conducted within Canada, Quorum Review applies the requirements for research ethics boards found in the Canadian Food and Drug regulations (Part C, Division 5). Quorum conducts its review in accordance with the ethical principles outlined in the Belmont Report.

In the U.S., an institutional review board (“IRB”) is a group of individuals responsible for reviewing a study to make sure that the research participant’s rights and welfare are protected. Most clinical research studies cannot begin without IRB approval. The IRB members generally include health care personnel such as doctors, nurses, and pharmacists. The IRB also includes other members of the scientific community, non-scientists such as clergy or social workers, and community members.

The IRB carries out its responsibility to protect the rights and welfare of research subjects by reviewing the protocol to make sure that risks to participants are minimized, that risks are acceptable in light of the possible benefits, that the informed consent document is accurate and complete in describing the study and its risks and benefits, and that the clinical research study is conducted in an ethical manner. If the IRB believes that these conditions have been met, it may approve the study and allow it to begin.

Once the clinical research study begins, the IRB is responsible for periodically reviewing the approved study to assure that the rights and welfare of research participants continue to be appropriately protected. Usually, the informed consent document will provide the research participant with a phone number to contact the clinical investigator or the IRB if the participant has a question or concern about how the study is being conducted.

A “research ethics board” (REB) performs the same function in Canada as an IRB does in the U.S. (see above). An REB is a group of individuals responsible for reviewing a study to make sure that the research participant’s rights and welfare are protected. Most clinical research studies cannot begin in Canada without REB approval. REB members generally include health care personnel such as doctors, nurses, and pharmacists. The REB also includes other members of the scientific community, non-scientists such as clergy or social workers, and community members. The REB carries out its responsibility to protect the rights and welfare of research subjects by reviewing the protocol to make sure that risks to participants are minimized, that risks are acceptable in light of the possible benefits, that the informed consent document is accurate and complete in describing the study and its risks and benefits, and that the clinical research study is conducted in an ethical manner. If the REB believes that these conditions have been met, it may approve the study and allow it to begin. Once the clinical research study begins, the REB is responsible for periodically reviewing the approved study to assure that the rights and welfare of research participants continue to be appropriately protected. Usually, the informed consent document will provide the research participant with a phone number to contact the clinical investigator or the REB if the participant has a question or concern about how the study is being conducted.

The informed consent form is the document that participants must sign before participating in a clinical research study. The informed consent document should give specific information about the study that you are considering and should contain the following information:

• The name of the clinical research study and its purpose
• A statement that the study involves research
• An idea of how long the study will last
• A description of procedures that will be performed, and whether any of the procedures are investigational
• A description of possible risks or discomforts associated with the study
• A description of any benefits to you or to others, if any, that are reasonably expected
• A description of possible alternatives, if any, to participation in the study that you should consider
• A description of the level of confidentiality that will be applied to your private health information and who may have access to your records
• A description of responsibility for costs or expenses associated with participation in the study, including study-related injuries
• Contact information for questions concerning the study or a research-related injury (usually the clinical investigator), and questions concerning research participant rights (usually the IRB/REB)
• A statement that participation in the study is voluntary and that a choice not to participate, or to discontinue participation, will not result in any loss of benefits or penalty to you

Other information may be included in a study’s informed consent form if the clinical investigator, the sponsor, and/or the IRB/REB believes that the information is needed to better inform you and assist you in the decision-making process.

The informed consent form will also have a signature line. When you or your legally authorized representative sign the informed consent form you have legally consented to participate in the study. You will be provided with a copy of the signed informed consent form for your personal records and as a reference tool throughout the study.

Signing the informed consent document should not be the first or the only step in the informed consent process. The signing of the consent form should only occur when you believe you have the information you need to make an informed decision. Prior to providing your signature, the clinical investigator or study staff member should sit down with you to discuss the study in detail and give you an opportunity to ask any questions you may have. That discussion should include a review of the information contained in the informed consent form itself. You may be asked to take the informed consent form home with you so that you have an opportunity to think about participation in the research study or to talk the matter over with your loved ones or friends. You should consider including a relative or friend in your discussions with the clinical investigator or study staff member if you believe their inclusion will help you with the decision making process.

The informed consent process extends throughout the study, well after the signing of the document. This means that you will be told about new information learned during the course of the study if it is decided that the information could have an impact on your decision to participate in the study. It also means that you can ask questions of the clinical investigator and study staff at any time during the study or after it is completed.

You should ask any question you believe will help you in the decision making process. Before meeting with the clinical investigator or study staff member, write your questions down, and feel free to take notes of the responses you are provided during the discussion. Some questions that you may want to ask include:

• What is the purpose of the study?
• What side effects may occur if I participate in the study?
• Has anyone been injured during participation in this study?
• Why does the clinical investigator or study staff member believe the study product may be effective or beneficial?
• Will I get the product being studied, and if not, why?
• How many people has the clinical investigator enrolled in this study?
• How many people are enrolled in this study in the U.S.? In the world?
• What tests, procedures, and medications are involved in this study?
• What are the alternatives to participation in this study?
• What are the possible downsides of participating in this study?
• What costs will I be responsible for in connection with this study?
• Will my insurance cover any costs associated with this study?
• Will I be paid for participation in the study?
• How long will I be in this study?
• Whom should I contact if I experience a side effect or complication?
• Whom should I contact if I have a question about the study?
• Whom should I speak with if I decide to end my participation in the study?

You should feel free to take the time you feel is necessary to decide whether to participate in a clinical research study. This may mean several discussions with the clinical investigator or study staff member. That is okay, because in the end, it is your decision whether or not to participate, and you need to feel comfortable with that decision.

If the single site option is chosen:

• Information will only be released to the site.
• The site is responsible for safety reporting (please see more information on this below).
• The sponsor is not able to submit on behalf of all sites in a multiple single site study.
• It is more costly to submit multiple single sites under the same protocol then to submit the study as a central study.

At Initial Review, in addition to all site-specific submission materials (Site Information Questionnaire, current CV, and other attachments as applicable) the site is also expected to submit all materials needed for the review of the Protocol including the Protocol, Consent Form, Investigator Brochures and Package Inserts, and any data collection tools. A complete list of the items needed for a single site submission is available on the first page of the single site Study Questionnaire. 

Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions.

Please see the Study Start-Up Process section of the site for forms and information about getting started. To ensure that the review process goes smoothly, please coordinate your submission with the sponsor for the study. Feel free to contact the Site Support Team with any questions about the submission process.

Quorum Review IRB has three Boards and conducts up to fourteen convened Board meetings a week. New U.S. protocols can be submitted to three of these meetings (to Board I (Tuesday and Friday) or Board II (Wednesday)). To be scheduled to a meeting for review, a submission must be received (with all required elements) by 5:00 p.m. Pacific Time one (1) week prior to the meeting. U.S. amendments can be submitted to one of the daily meetings (Board III) and must be submitted by 5:00 p.m. PT 36 hours prior. Canadian research must be submitted (with all required elements) to the Wednesday meeting (Board II) by 5:00 p.m. PT the prior Wednesday.

Quorum posts the Board Roster on our web portal. You can find this by logging on to the web portal and selecting “IRB Roster.” Quorum also posts archived Board Rosters in this location if you need to locate a past Board Roster for your records.

Your Study Manager will be your key point of contact for protocol-related issues. The Study Manager will attend Board meetings where your study will be discussed and will communicate determinations back to you.

Once a complete set of submission elements is submitted for review, Quorum will assign a Study Manager to your study and schedule a review date. Following the Board review, your Study Manager will contact you with the outcome, including any consent form revisions or further information that the Board has requested.

If the Board has requested consent form revisions, you will be asked to review them and submit additional changes as appropriate. Once the consent forms are finalized and any follow-up issues are resolved, your Study Manager will provide you with a Letter of Approval.

Quorum works with sponsors to make sure that studies are started as quickly as possible. However, Quorum cannot issue final approval documents to the sites until they have been approved and the consent form has been finalized. If the timeline is tight it is especially important to respond to your Study Manager with any feedback on the consent form as quickly as possible so that the consent form may be finalized in a timely manner. Once the protocol has been reviewed sites may be scheduled for review while the Board and sponsor negotiate the consent form language. This helps minimize delays. Another item to note, complete site submissions must be received one week prior to a Board meeting to ensure review at or before that meeting; therefore, it would be best that your target site(s) submit as soon as possible.

The Quorum Review IRB OnQ Portal is password-protected and available to study contacts at the site and sponsor level. Please contact Quorum Review IRB to learn more about this service or to request a portal account. Users can view, download, and print all Quorum Review IRB approval documents and most other Board correspondence. The OnQ Portal also offers a status report for tracking site submissions from initial review through the Board’s final decision. Users can submit materials for review electronically and securely through the OnQ Portal provided that the submission is not larger than 30 MB. For items that are larger than 30 MB either use a compression utility such as WinZip or e-mail items that are less than 50 MB to InitialStudySupport@QuorumReview.com. Alternatively you can mail or fax to the attention of Initial Study Support.

The primary contact for a study, as designated on the Central Study Questionnaire, is automatically granted portal access for the study. If the primary contact would like to request to have additional users added or removed there are many ways to accomplish this. Prior to submitting your study the last page of the CSQ allows you to list additional users. Additionally, the primary contact can request additional users via email to their Study Manager or Quorum’s Initial Study Support team. It is also possible to request additional users through the Quorum web portal.

All documents for a study may be submitted via the OnQ Portal. Or, after your initial study submission any protocol-level information may be submitted to your assigned Study Manager via email. Quorum accepts this information via mail as well.

Yes. Log in to Quorum’s OnQ Portal, and click on “Reports.” Then, you can generate a site submission status report for any of the Protocols to which you have access. You will be able to see the status of the site (approved, in progress, not yet active) and whether any information is still needed for the site’s submission to be complete.

Quorum asks that you track any requested changes into the clean, current version of the consent form and that you submit these changes along with the rationale for the changes. This allows the Board to see what changes have been requested to the current approved version of the consent form. Please turn on the “track changes” feature in Microsoft Word, and submit the consent form revisions electronically.

Please start by referencing Quorum’s Guide to Consent Form Development. In the tracked version of the consent form(s), you will see a superscript number (a small number slightly above the rest of the line) after each change or group of changes that correlates to a rationale for change in the document (attached). The superscript numbers do not appear in the “clean” version of the consent form(s). If you have any additional questions regarding the changes that were requested, please contact your Study Manager for more information.

Please contact Quorum Review IRB’s Initial Study Support team; they will provide you with your own account.

Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Initial Study Support at (877) 472-9883 or InitialStudySupport@quorumreview.com if you’d like more information about this process.

Your site can be reviewed by Quorum if your Institution is willing to waive jurisdiction. With your submission, please include either Quorum’s Institutional Jurisdiction Waiver Form or an Institutional Authorization Agreement (IAA). Quorum also will accept the template IAA posted on the OHRP website . Please be sure to respond appropriately to questions 18. a., b., and c. of the Site Information Questionnaire.

Quorum reviews Federally Funded studies. There are additional submission requirements for any federally funded studies, for more information on what is required please see the Federally Funded Research section of this website.

An independent IRB does not need to obtain a Federalwide Assurance (FWA). An FWA is required for institutions that are engaged in research conducted or supported by a federal agency (such as HHS.) An IRB itself is not engaged in the research nor is it a direct recipient of federal funds. However, an FWA requires the institution to designate one or more IRBs that review research for the institution. If the institution does not have an internal IRB designated on its FWA, then it must designate an external IRB that reviews the largest percentage of the research covered by the FWA. All IRBs must be registered with OHRP before they can be listed on an institution’s FWA. If an institution wishes to add an external IRB to its FWA as an IRB of Record, it must use the IRB’s OHRP registration number. More information is available at http://answers.hhs.gov/ohrp/categories/1563 .

Quorum’s OnQ Portal offers convenient access to all site approval documents, consent forms, formal acknowledgments, and other IRB correspondence. A site may grant access to anyone that they would like, and this is an excellent way to keep the Institution involved in what is happening with your study.

Yes, Quorum is AAHRPP Accredited.

Yes. Quorum offers a wide range of options. If Quorum is not the Central IRB, you may choose to submit as a Single Site. Please see Quorum’s Single Site page for more information.

Quorum will issue an acknowledgement letter to the site when a revised Investigator Brochure is received. When all other safety information is received, such as Protocol Deviations, IND safety reports, Serious Adverse Event reports, and reports of Unanticipated Problems, Quorum will issue a standard acknowledgment. In the case of a standard acknowledgement, Quorum will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

At Initial Review, in addition to all site-specific submission materials (Site Information Questionnaire, current CV, and other attachments as applicable) the site is also expected to submit all materials needed for the review of the Protocol including the Protocol, Consent Form, Investigator Brochures and Package Inserts, and any data collection tools. A complete list of the items needed for a single site submission is available on the first page of the Single Site Study Questionnaire. Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions. Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions.

Quorum defines a study as single site or central based upon with whom we communicate.

Single site: Quorum communicates directly with the site only. In this case, Quorum is not the central IRB for the study but the site has chosen Quorum as their IRB.

Central: Quorum communicates with the sponsor/CRO, protocol level decisions are made by the sponsor/CRO on behalf of site(s). In this case, Quorum is the designated central IRB for the study.

If the single site option is chosen:

• Information will only be released to the site.
• The site is responsible for safety reporting (please see more information on this below).
• The sponsor is not able to submit on behalf of all sites in a multiple single site study.
• It is more costly to submit multiple single sites under the same protocol then to submit the study as a central study.

At Initial Review, in addition to all site-specific submission materials (Site Information Questionnaire, current CV, and other attachments as applicable) the site is also expected to submit all materials needed for the review of the Protocol including the Protocol, Consent Form, Investigator Brochures and Package Inserts, and any data collection tools. A complete list of the items needed for a single site submission is available on the first page of the Single Site Study Questionnaire. Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions. Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions.

Quorum will issue an acknowledgement letter to the site when a revised Investigator Brochure is received. When all other safety information is received, such as Protocol Deviations, IND safety reports, Serious Adverse Event reports, and reports of Unanticipated Problems, Quorum will issue a standard acknowledgment. In the case of a standard acknowledgement, Quorum will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Initial Study Support at (877) 472-9883 or InitialStudySupport@quorumreview.com if you’d like more information about this process.

Typically, changes to sub investigators do not need to be reported to Quorum. The only exception is if Quorum requested the departing sub investigator’s CV during study start up.

You only need to notify Quorum of changes that affect your contact address or information on your consent form.

Quorum only sends approval documents to sites when the change that has been submitted affects the consent form (such as an address or telephone number change). For all other changes, if the changes are submitted using the OnQ Portal you will receive an acknowledgement that the request was received. Quorum staff will update our records accordingly.

The Change Request Form for Sites may be used to request the following changes:

• Change in Additional Research Facility
• Change in Participant Emergency Numbers
• Change in Site Contact Information
• Change in Compensation of Study Participants
• Request for Translated Consent Form
• Change in Primary Facility Business Name

Download a copy of the Change Request Form for Sites here

A change in principal investigator must be reviewed by the Board and cannot be submitted for review until all of the following documents are received:

• A letter from the departing principal investigator explaining why he/she is no longer able to perform the role of principal investigator (if the departing principal investigator is not available to provide a letter Quorum will alternatively accept a written explanation from the new principal investigator).
• “Change in Principal Investigator” form, “Site Information Questionnaire” form or “Observational Registry Site Information Questionnaire” form, if applicable.
• A current (within two years), dated CV for the new principal investigator. Effective January 2008, the PI needs to submit a CV only once. We do not need additional copies of the CV for subsequent site submissions.) For observational registry studies a CV is not required.
• Supplemental material as appropriate based on “Change in Principal Investigator” Form responses (for example, FDA Audit information, letters of explanation, etc.).

If your main facility has moved, please submit the Change in Primary Facility Form to Quorum.

Your site can be reviewed by Quorum if your Institution is willing to waive jurisdiction. With your submission, please include either Quorum’s Institutional Jurisdiction Waiver Form or an Institutional Authorization Agreement (IAA). Quorum also will accept the template IAA posted on the OHRP website . Please be sure to respond appropriately to questions 18. a., b., and c. of the Site Information Questionnaire.

Quorum reviews Federally Funded studies. There are additional submission requirements for any federally funded studies, for more information on what is required please see the Federally Funded Research section of this website.

An independent IRB does not need to obtain a Federalwide Assurance (FWA). An FWA is required for institutions that are engaged in research conducted or supported by a federal agency (such as HHS.) An IRB itself is not engaged in the research nor is it a direct recipient of federal funds. However, an FWA requires the institution to list all IRBs that review research for the institution. All IRBs must be registered with OHRP before they can be listed on an institution’s FWA. Therefore, when an institution wishes to use the services of an independent IRB, it must add the IRB to its FWA as an IRB of Record using the IRB’s OHRP registration number. More information is available at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html

Quorum’s OnQ Portal offers convenient access to all site approval documents, consent forms, formal acknowledgments, and other IRB correspondence. A site may grant access to anyone that they would like, and this is an excellent way to keep the Institution involved in what is happening with your study.

Yes, Quorum is AAHRPP Accredited.

Yes. Quorum offers a wide range of options. If Quorum is not the Central IRB, you may choose to submit as a Single Site. Please see Quorum’s Single Site page for more information.

If a sponsor or site anticipates any non-English speaking individuals will participate in a Quorum Review IRB approved protocol, then translation of the informed consent document and participant recruitment material(s) into a language understandable to the individual is required. This requirement is in compliance with applicable regulations which state that an informed consent document should be in an understandable language to the subject (or authorized representative). Also, before a site requests translation of study documents, the site must confirm the sponsor/protocol allows enrollment of non-English speaking participants.

When submitting a new study to Quorum, sponsors, CROs and single sites may request our translation services in the Central Study Questionnaire, Single Site Study Questionnaire, or Principal Investigator Generated Study Questionnaire. There are various options for when you prefer the translation process to begin. Please contact Quorum’s Initial Study Support team for assistance with completing our submission forms. If you have already submitted to Quorum, you can update your translation preferences by submitting a Change Request Form for Sites. 

Central study sites should contact their sponsor and ask them to request Quorum’s translation services for the study. Please also indicate on your Site Information Questionnaire that you will be enrolling non-English speaking participants. If you have already submitted to Quorum you may submit a Site Information Change Request Form to request translations.

Yes, a customer may use their own vendor to translate study documents. Quorum generally accepts valid translation certificates, including those from professional translation companies and in-house translation teams employed by a sponsor, CRO, site, or institution. In addition, Quorum generally accept translation certificates from an individual employed by a sponsor, CRO, site, or institution who is fluent in English and the source language, provided that the employee’s primary responsibility involves the translation of study related documents. Quorum reserves the right to require a back translation or a translation comparison of any translated material submitted to verify the accuracy of the translation. Please contact your Study Manager or InitialStudySupport@quorumreview.com for more information.

Quorum generally requires translation certificates from an outside party contain the following elements:

• Name and contact information of the company employing the translator.
• The name of the document, including version and/or date if applicable, or other document identifier.
• Source and target language (for example, English into Portuguese).
• A statement of attestation that includes the following language (or very similar): “I hereby certify that the identified translated document is, to the best of my knowledge and belief, a true and accurate translation for the original source document.”
• Name, title and signature of the person certifying the translation.
• Date of the certification.

Quorum is dedicated to streamlining the translation of study material while maintaining appropriate safeguards for participants. Please contact your Study Manager if you have questions about your translation certifications, or about our requirements for a valid translation certificate.

Submission of Canadian French material for studies conducted at Canadian sites may be accepted with a translation certificate, or with an attestation from the investigator, sponsor, CRO, or site that the Canadian French document is an accurate representation of the English document. 

The attestation should state that the material was prepared by a business or employee of the investigator, sponsor, CRO, or site, who normally conducts business in Canadian French and English, and whose primary responsibility involves the creation, editing and/or translation of study-related material.

In order to enroll non-English speaking participants there must a non-family member, available on site, who is fluent in a language understood by the participant in order to assist in the consenting process.

Quorum takes into a consideration many factors in the billing process. For translation projects, Quorum will charge per word fees, discounted per word fees for similar segments previously translated, and/or hourly fees in depending on the translation project. Additionally, Quorum has a standard handling fee that applies to all translations. Quorum strives to exceed industry standards while remaining competitive with the pricing of our translation service. Please contact your Study Manager or Quorum’s Initial Study Support team to request a quote, or if you have billing questions.

On the Site Information Questionnaire, the Quorum asks the site to confirm that the Principal investigator and research staff understands the role of the Ethical Review Board, the importance of the informed consent process, and other pertinent aspects of human participant protection. If Human Research Participant Protection Training has not been conducted, the Board may require additional investigator or staff training.

Quorum expects Principal investigators to be responsible for the conduct of research trials and all associated research facilities consistent with the IRB-approved protocol, applicable law and regulations, applicable federal and ICH Guidelines for Good Clinical Practice, and ethical principles of the Belmont Report.

CITI stands for the Collaborative Institutional Training Initiative. This program provides training modules in Good Clinical Practice, Basic Courses in the Protection of Human Research Subjects, Responsible Conduct of Research (RCR), and a variety of other subjects. Quorum provides access for Principal investigators and study coordinators, and other study staff. Please see the Instructions for joining CITI through Quorum Review for information on how to initiate CITI training.

Read more about Quorum Review’s CITI training here

Yes. On the Central Study Questionnaire that is required with new study submissions, Quorum asks if the investigator would like Quorum to send a representative to attend the investigator meeting and provide training. This is a great way for sites to learn how to work with Quorum and can ensure complete site submissions and fewer questions later in the study regarding safety reporting, continuing review, and study closure. Please contact Initial Study Support if this is something you’d be interested in.

Some research activities that involve human subjects may be exempt from IRB review under certain conditions pursuant to 45 CFR 46.101(b) (federally funded projects), 21 CFR 56.104(d) (FDA regulated studies), and the Tri-Council Policy Statement (TCPS 2), Article 2 (Canadian Research). An applicant may therefore apply to Quorum Review for an exemption determination.

If you would simply like more information regarding how to make an exempt determination please refer to the Quorum handbook.

Quorum accepts Exemption Determination Request via the OnQ Client Portal, email to our Initial Study Support department, fax, or mail.

Quorum Review
Initial Study Support Department
1601 Fifth Ave., Ste. 1000
Seattle, WA 98101
Fax: 206-448-4193
InitialStudySupport@quorumreview.com

For an exemption determination, the Quorum Review Request for Exemption Determination Form should be completed. Additionally, a copy of the final protocol or research proposal is required.

Our Initial Study Support department should be contacted with any questions regarding exemption determination requests. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.

Quorum Review IRB is registered with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and with the Food and Drug Administration (FDA) with registration number IRB 00003226.

Prior to the Board’s review of federally-funded research, the following documentation must be submitted in addition to other required material for review of new protocol submissions:

• A completed Federal Funding Addendum (available on our website).
• A complete copy of the applicable grant application or other funding application. (The grant application or other funding applications typically does not need to be reviewed by Quorum Review IRB for a non-awardee institution involved in a multi-site research project).
• A copy of the federal contract (if available).
• A valid Federal Wide Assurance (FWA) number. A Federal Wide Assurance (FWA) must be filed for each legal entity engaged in the federally funded study as required by 45 CFR § 46.103 and in accordance with the following OHRP guidance: “Engagement of institutions in Research”http://www.hhs.gov/ohrp/policy/engage08.html. You can submit the FWA form electronically on the OHRP website. For more information visit: http://www.hhs.gov/ohrp/assurances/assurances/file/index.html. (Please contact the applicable agency if using a different assurance process other than a FWA).
• A completed IRB Authorization Agreement (IAA). (Quorum Review IRB will accept any standard IAA form. You may obtain Quorum’s template IAA from our website).

Please contact Quorum Review IRB’s Initial Study Support team for clarification or assistance regarding these requirements.

An independent IRB does not need to obtain a separate Federal Wide Assurance (FWA). It is generally accepted that the IRB is not actively engaged in the research nor is it a direct recipient of federal funds. Consequently, the IRB can be considered a sub-contractor and as such should be listed on the Sponsor’s FWA form as the IRB of record.

To designate Quorum as an IRB of Record on the FWA, simply include “Quorum Review IRB” and Quorum’s IRB registration number IRB00003226 on the FWA.

For more information on Federal Wide Assurances, visit the U.S. Department of Health and Human Services website at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html. Please contact Quorum Review IRB’s Initial Study Support team for clarification or assistance regarding these requirements.

Quorum asks that you submit a finalized version of the protocol that is separate from the grant. It is recommended that you review the Quorum Handbook for information on Board expectations for protocols to be considered for review. This information is available in Appendix A of Quorum’s Handbook, protocol Contents.

A Certificate of Confidentiality is a document that federal agencies issue to investigators to protect the privacy and welfare of subjects by preventing the release of protected health information and other sensitive information regarding subjects who are participating in a research study. Certificates of Confidentiality allow investigators to refuse to disclose identifying and sensitive information obtained as part of research, in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. An investigator should consider obtaining a Certificate of Confidentiality for IRB-approved research when he or she collects information from or about a subject that is identifiable and sensitive (i.e., could lead to discrimination, social stigmatization, legal prosecution, damage to their financial standing, employability, insurability, or reputation).

Even if a Certificate of Confidentiality is issued, research investigators should be aware that federal, state, or local law may require that licensed health care providers and/or certain other individuals report identifiable information regarding subjects involved in research if they have reasonable cause to suspect issues such as child abuse, a possible threat to self or others, or reportable communicable disease. Other disclosures may also be required by federal, state, or local law. For example, Certificates of Confidentiality do not authorize researchers to refuse to disclose information regarding a subject if such disclosure is required by federal law (e.g., required disclosures as set forth in the Food, Drug, and Cosmetic Act or if federal agency requests information for auditing or program evaluation purposes).

No. Quorum does not require an investigator to apply for Certificate of Confidentiality.

An institution may enter into confidentiality agreements between its research investigators and the institution’s IRB so that investigators can access records without a subject’s written consent or authorization. Such agreements vary, but they usually describe the investigator’s obligations and responsibilities regarding the confidentiality and use of those records.

The protection of a Certificate of Confidentiality applies only if the data is sent to and maintained in the U.S.

A number of federal agencies issue Certificates of Confidentiality, including the Food and Drug Administration (FDA). For a list of other Department of Health and Human Services (HHS) agencies that issue the Certificate, see http://www.hhs.gov/about/index.html#agencies. Information related to NIH-funded research and Certificates of Confidentiality can be found at http://grants.nih.gov/grants/policy/coc/faqs.htm.

Participants must be informed in the informed consent document regarding the limitations and protections of the Certificate of Confidentiality. Please notify Quorum Review IRB if you have requested or will be requesting a Certificate of Confidentiality. Also note that if a Certificate of Confidentiality is obtained after the study has commenced, the consent form will need to be revised in order to inform subjects about the Certificate, including its limitation and protections.

Please contact Quorum Review IRB if you have questions regarding what type of language needs to be included in the consent form. If Quorum is notified that a Certificate of Confidentiality has been or will be obtained, Quorum can also include standard template language in the consent form.

The researcher is provided with a tracked version of the consent form(s) prior to the Board meeting. The researcher can then respond to Quorum’s edits prior to the Board meeting, often saving a round of negotiation after the Board meeting. This process can reduce study start-up time.

Additional changes may be requested by the Board. However, this process often saves time during consent form negotiation.

Yes, please see the Additional Services pricelist for more information.

If you would like to utilize accelerated consent form processing at the start of your study, please contact your Study Manager.

An applicant may apply to Quorum Review IRB for a determination of whether a proposed activity is human subjects research in accordance with applicable U.S. federal regulations and/or the Canadian Tri-Council Policy Statement(TCPS 2): 21 CFR 50.3(c) and (g); 21 CFR 56.102(c) and (e); 45 CFR 46.102(d) and (f); TCPS 2 Article 2.1.

Quorum accepts Human Subject Research Determination requests via the OnQ Client Portal, email to our Initial Study Support department, fax, or mail.

Quorum Review
Initial Study Support
1601 Fifth Ave., Ste. 1000
Seattle, WA 98101
Fax: 206-448-4193
InitialStudySupport@quorumreview.com

For a Human Subject Research Determination, the Quorum Review Human Subject Research Determination Request Form should be completed. Additionally, a copy of the final protocol or research proposal is required.

Our Initial Study Support department should be contacted with any questions regarding Human Subject Research Determination requests. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.

Quorum defines a study as single site or central based upon with whom we communicate.

• Single site: Quorum communicates directly with the site only. In this case, Quorum is not the central IRB for the study but the site has chosen Quorum as their IRB.
• Central: Quorum communicates with the sponsor/CRO, protocol level decisions are made by the sponsor/CRO on behalf of site(s). In this case, Quorum is the designated central IRB for the study.

A chairperson study assessment can expedite the study start-up process because it allows the sponsor and a member of the Board to address possible issues and to answer questions before the study is reviewed by the full Board. Some examples of when a chairperson study assessment may be appropriate are, if the sponsor is proposing a complex trial design, trying to decide if a placebo arm is appropriate within a given population or trying to establish the right age range of participants, or other design or consent form related questions. Obtaining feedback early in the process often helps simplify the post-review negotiations and minimizes Board modifications.

No, Quorum offers this service free of charge.

If you would like to schedule a chairperson study assessment, please contact our Initial Study Support team at InitialStudySupport@quorumreview.com.

Please submit a draft or final version of your protocol and any supplementary materials such as investigator’s brochures, package inserts, or device background literature for all primary and comparator drugs/devices. In addition, if there are specific questions regarding the informed consent document, it may be helpful to provide a copy of the proposed informed consent. It is also helpful to provide a list of questions for discussion ahead of time to help guide the discussion.

In order to allow sufficient time for the IRB Chairman to review your materials, please submit all documents one week prior to the scheduled chairperson study assessment, if possible.

Chairperson study assessment teleconferences are led by the IRB Chairman. Representatives from Initial Study Support, Study Management, and Regulatory also attend the meetings.

Quorum primarily provides chairperson study assessment services for new protocols in order to help guide sponsors as they are writing their protocol or deciding on the specific study design. There also may be times when a sponsor requests a chairperson study assessment of the informed consent document. Quorum can provide this service as well. This service is free of charge if no consent form edits are made. If the consent form is edited by Quorum’s consent form team at the request of the sponsor, this service falls under the category of “Consent Form Consultation / Editing.”

The opinions expressed in the chairperson study assessment are reflective of one individual Board member and may not always represent the opinions of the full Board. While the IRB Chairman cannot speak on behalf of the full Board, he has several years of experience working with Quorum Review IRB and its members and has a good sense of what criteria may be important to the Board.

If you are a Principal Investigator submitting a PI generated study, the IRB Chair pre-reviews all study-related materials before the study is submitted to the convened Board for review. If necessary, Quorum will contact you if additional information or a chairperson study assessment teleconference is required. You may also request a chairperson study assessment teleconference. For additional guidance see the Investigator Generated Studies page.

Consent form consultation/editing can expedite the study start-up process because it allows the sponsor and Quorum’s Consent Form Development Team to address any consent form language issues before the consent form is reviewed by the full Board. Obtaining feedback early in the process often helps simplify the post-review negotiations and minimizes Board modifications.

Yes, please see Quorum’s price list, located on the OnQ™ portal, for more information.

If you would like to schedule a consent form consultation/editing, please contact our Client Relations department at clientrelations@quorumreview.com.

Please submit a draft or final version of your protocol and the informed consent document(s).

The opinions expressed in the consent form consultation are reflective of the consent form development group and not Quorum’s Board. The Board may request additional changes to the consent form during fully convened Board review.

Yes. Quorum Review IRB maintains an ethics review board (referred to as the “North American” Board) and serves as a both a duly convened research ethics board (REB) as well as a central institutional review board (IRB). The North American Board complies with Canadian and U.S. requirements and meets every Wednesday to review U.S. and Canadian studies. Quorum accepts both privately and publicly funded research. Quorum is subject to the same provincial restrictions that apply to other central REBs in Canada. Therefore, Quorum does not provide review in Alberta, Newfoundland and Labrador, and Saskatchewan. In Quebec, Quorum reviews only studies involving adult participants.

The Tri-Council Policy Statement (TCPS 2) is a Canadian Government policy statement that sets ethics standards for conducting research on human subjects. The agencies that make up Tri-Council are as follows: (1) Canadian Institutes of Health Research (CIHR), (2) Natural Sciences and Engineering Research Council of Canada (NSERC), and (3) Social Sciences and Humanities Research Council of Canada (SSHRC). These agencies will consider funding organizations that certify that they will comply with the TCPS 2 for the research study involving human subjects. Many organizations apply the TCPS 2 standards to all studies even if only specific studies are being funded by one of the three agencies. In addition, many organizations voluntarily apply the TCPS 2 to all studies as a matter of policy even if no public funding is being received for any study.

Yes. Quorum will review Canadian research in accordance with applicable regulations and guidelines, including the Tri-Council Policy Statement (TCPS 2).

Since many organizations in Canada have voluntarily elected to adopt TCPS 2, even if they are not required to do so, there is a likelihood that we will encounter a site that will require Quorum to comply with the TCPS 2. As a matter of policy we therefore apply the TCPS 2 to all studies unless the organization provides and explanation regarding why it should not apply.

In accordance with Article 11.11 of the Tri-Council Policy Statement (TCPS 2), Quorum’s REB is required to review the clinical trial budget for Canadian studies in order to “ensure that conflicts of interest are identified and minimized, or otherwise managed.”

Although compliance with provincial and local law requirements are ultimately the responsibility of the principal investigator, Quorum has developed consent forms that are in compliance with provincial and local law requirements where Quorum provides review.

PIPEDA refers to the federal Personal Information Protection and Electronic Documents Act (S.C. 2000, Ch. 5) (Federal Act). The Act applies to all organizations that collect, use or disclose personal information in the course of commercial activities. The term “commercial activity” means any particular transaction, act or conduct or any regular course of conduct that is of a commercial character. Clinical research under contract to a private organization is a “commercial activity”. As of January 1, 2004, the Act applies to all personal information collected, used or disclosed in the course of all commercial activity. Note: If a province passes a law that is substantially similar to the Federal Act, the organizations or activities covered by the provincial law will be exempted from the federal law for collection, use, or disclosure within the province.

Yes. Quorum’s template consent form is PIPEDA compliant, but it is the ultimate responsibility of the of the principal investigator to comply with the federal, provincial, and local law requirements.

The North American Board meets every Wednesday to review U.S. and Canadian studies.

Yes. Quorum Review IRB has an office in Canada; however, our staff is available at the main office in Seattle to support Canadian sites and research. Please send all submissions to the main Seattle office.

Yes. Quorum can provide French Canadian translations and offers translation services in over 100 languages and dialects for all study related documents. By coordinating translation through Quorum staff, you can help ensure that additional translations are not needed for your study documents for submission to the Board. Please contact your Study Manager if you would like more information regarding these services.

For sites with personnel and/or study subjects who speak French, Quorum can provide French translations of the study Consent Form(s) and any other participant materials (such as diaries, recruitment materials, etc.). Quorum also has a phone support system in place with a dedicated mailbox for study personnel and participants who speak French.

Because of the different regulatory requirements in the US and Canada, Quorum issues separate protocol approval documents for the U.S. and Canadian arms of a study.

All Board correspondence will be posted to the OnQ Portal for U.S. and Canadian studies. Sponsors that are approved to conduct research in both the U.S. and Canada will see two separate links to their approval documents when logging into the OnQ Portal. One link will route you to the U.S. arm and another link will route you to the Canadian arm. To easily identify the Canadian arm vs. the U.S. arm, Quorum has assigned an identical Quorum Review tracking number (QR#) with an addition suffix for the Canadian arm. The U.S. arm will contain our standard 5 digit number (e.g. QR# 23333) and the Canadian arm will be assigned the same number with an additional suffix (e.g. QR# 23333CDN).

In addition to Quorum’s standard submission requirements, Canadian sites must provide a copy of the Principal Investigator’s Medical License. A copy of the sites Clinical Trial Budget should also be provided, if applicable.

Quorum will issue an acknowledgement letter to the site when a revised Investigator Brochure is received. When all other safety information is received, such as Protocol Deviations, IND safety reports, Serious Adverse Event reports, and reports of Unanticipated Problems, Quorum will issue a standard acknowledgment. In the case of a standard acknowledgement, Quorum will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

No, Quorum does not review or acknowledge the FDA Form 1572. Quorum’s SIQ collects all the information that Quorum needs from the 1572.

Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Quorum’s Site Support Team at (877) 472-9883 or sitesupport@quorumreview.com if you’d like more information about this process.

A CV is not required for an observational registry site submission. Depending on the answers to the questions on the Observational Registry SIQ, supplemental materials (e.g., for an additional facility or audit information) may still be required.

No, Quorum does not review or acknowledge the FDA Form 1572. Quorum’s SIQ collects all the information that Quorum needs from the 1572.

You can contact the Site Support Team or your sponsor and they will be able to tell you if the protocol has been approved as an “Observational Registry” study.

You CANNOT submit using the standard SIQ if the study has been qualified as observational registry. Utilization of the standard SIQ will cause your site to be held from review until the complete Observational Registry SIQ is received.

Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Quorum’s Site Support Team at (877) 472-9883 or sitesupport@quorumreview.com if you’d like more information about this process.

Quorum Review IRB accepts Investigator Generated Studies. Generally, in these types of studies, the principal investigator is acting as both the sponsor and the investigator (a “sponsor-investigator” under FDA regulations). This means that the principal investigator initiates and conducts the research. In addition to Quorum’s standard site submission forms, for Investigator Generated studies the Principal Investigator is responsible for submitting all study-level information for review as well.

At Initial Review, in addition to all site-specific submission materials (Site Information Questionnaire, current CV, and other attachments as applicable) the site is also expected to submit all materials needed for the review of the protocol including the Protocol, Consent Form, Investigator Brochures and Package Inserts, and any data collection tools. For Investigator Generated studies there are additional requirements, please contact Initial Study Support for details. 

Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), the site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator Brochures). Sites are also expected to promptly submit any Amendments, and consent form revisions.

All Investigator Generated Studies submitted to Quorum Review IRB require pre-review by the Quorum Medical and Legal-Regulatory Consultants. During pre-review, the Consultants may request revisions or additional information before the submission can be scheduled for full Board review. This can extend the submission timelines considerably.

It is recommended that you review the Quorum Handbook for information on Board expectations for protocols to be considered for review. This information is available in Appendix A. Also, Quorum has developed a sample consent form which investigators are encouraged to use for guidance in developing consent forms. Quorum also has developed sample genetics consent forms and age appropriate consent forms. These can be provided upon request.

Quorum generally will not review research where a Sponsor-Investigator is also the sole sponsor of the IND, but may make exceptions on a case-by-case basis. For example, the Board may make an exception in instances where there are additional local protections for subjects that would be recruited for this type of research. The most common exception is where the Sponsor-investigators are still under the jurisdiction of an organization that provides the added protection of organizational policies and procedures, including the management of conflicts of interest, reporting of unanticipated problems and serious or continuing non-compliance, and reporting of scientific misconduct. Additionally, an exception may be made for this type of research if there is an Agreement between the organization and Quorum which requires Quorum to report certain events and actions to the organization. Such an agreements is further evidence that the organization has jurisdiction over of the Sponsor-investigator. Any restrictions imposed based on the forgoing however shall not apply to treatment INDs submitted by Principal Investigators.

The mere provision of funds to a principal investigator to conduct research does not make the outside source the sponsor of the research. A “sponsor” has specific responsibilities concerning the research being conducted.

Yes. You should follow the instructions for the submission of federally-funded research.

Quorum will issue an acknowledgement letter to the site when a revised Investigator Brochure is received. When all other safety information is received, such as Protocol Deviations, IND safety reports, Serious Adverse Event reports, and reports of Unanticipated Problems, Quorum will issue a standard acknowledgment. In the case of a standard acknowledgement, Quorum will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

No, Quorum does not review or acknowledge the FDA Form 1572. Quorum’s SIQ collects all the information that Quorum needs from the 1572.

Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Quorum’s Site Support Team at (877) 472-9883 or sitesupport@quorumreview.com if you’d like more information about this process.

Quorum requires the following documents:

• “Site Information Questionnaire: Primary Research Facility” form
• Principal investigator’s Curriculum Vitae including clinical research experience with human subjects and education (if applicable,the principal investigator needs to submit a CV to Quorum only once)
• Canada sites only: Hard copy of principal investigator’s Medical License

The SIQ instructions will alert you if any of the following elements are needed.

• “Site Information Questionnaire: Additional Research Facility” form
• Proposed site-specific advertisements and recruitment materials. These materials should be accompanied by written sponsor approval if this is required by the sponsor
• Proposed site-specific participant study materials (diaries, questionnaires, written study instructions, etc.)
• Supplemental material as appropriate based on “Site Information Questionnaire” responses (for example, FDA Audit information, letters of explanation, etc.)

The most common item area of confusion on the Site Information Questionnaire is the question on participant compensation. Please ensure that the per visit amount multiplied by the number of visits equals the total amount you have provided. Also, please ensure that you provide information on whether your site is planning to compensate participants for any substudies, if there are any. 

Additional delays are caused when sites fail to completely and accurately respond to all questions on the SIQ. The best way to prevent this error is to address ALL questions and if you feel the question doesn’t pertain to your site write in “N/A” rather than leaving it blank. 

To ensure that your submission is complete and able to be processed immediately upon receipt by Quorum, please reference the SIQ workbook on the forms tab. If you have any questions regarding your submission, please contact the Site Support Team.

The CV must describe the principal investigator’s education, licensure (for all states in which the research is being conducted), training, clinical background, and research experience relevant to the study in question. If the principal investigator’s relevant research experience is not included in the CV, please provide additional documentation as necessary.

No, Quorum does not review or acknowledge the FDA Form 1572. Quorum’s SIQ collects all the information that Quorum needs from the 1572.

From time to time, Quorum’s Board will request submission of sub investigator’s CVs. Your sponsor probably will notify you if this request is made. Less frequently, the Board might ask for additional information about your site.

If you aren’t certain if your site has submitted to Quorum before you can contact Site Support, the protocol Study Manager or the Initial Study Support team.

The location where patients are being seen and research is being conducted should be listed as the primary research facility on the SIQ. The administrative facility can be listed as the contact address. There is no need to fill out an additional form for administrative facilities.

The AFSIQ needs to be completed and submitted in conjunction with the SIQ if you have more than one facility at which more than minimally invasive procedures are being performed.

Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Quorum’s Site Support Team at (877) 472-9883 or sitesupport@quorumreview.com if you’d like more information about this process.

By insuring that your site’s compensation schedule is accurate and reflective of the consent form language determined by Quorum and the sponsor. 

Throughout the past year, Quorum has been analyzing data we collect on the reasons for held submissions. Our #1 hold reason is compensation issues. To better assist our clients, we have assembled a list of items you should review before sending your submission documents to Quorum. By going through this list, you can save yourself the delay of having us contact you to resolve issues which may arise from your payment plans. 

1. Did you add up the amount per visit and does it match the total you have listed on the SIQ (or compensation attachment)? Something as simple as making sure the ‘per visit’ amount adds up to the total you provide is a common error that is often overlooked.
2. Ask your sponsor if there are any special compensation parameters for this study when they send you your enrollment forms. Some studies have very specific arrangements for payment. Find out before-hand if your study has any of these requirements.
3. Feel free to use the Compensation Template available in the forms section of our website. The template provides you with a table format to easily list your visit payments and the combined total for the visits.
4. Unless the study specifically states otherwise, please remember that a total for all visits is required for review by Quorum. While you may request that the total not be included in the consent form verbiage (which we typically allow unless the sponsor has locked the model language), we must always know the total possible for a participant to receive – it must be listed on the SIQ or the compensation attachment you provide. If you do not want the total listed on the consent form, and the language is allowed to be modified per the sponsor, please write a note on your SIQ’s compensation section indicating your choice to do so. Again, you must still list the total on the SIQ for your submission to be reviewed.
5. If the study you are conducting has a sub-study associated with it or a study that may involve a caregiver consent form, be sure to find out if compensation plans are required for those as well. Contact your sponsor prior to submission to find out if there are special compensation worksheets or attachments that your study will use. This can include – but is not limited to – genetics, biomarker, or Caregiver consent forms. If you are not compensating for these things, please be sure to indicate that as well. Do not assume Quorum will automatically know your plans not to compensate.

Observational registries are limited to data collection and do not include any procedures or interventions conducted specifically for the research (including randomization or assignment to treatment groups). Minimal risk registries involve only minimal risk interventions (for more information on minimal risk procedures, please refer to the Quorum Handbook). In order for Quorum to review a study under the “Registry” designation, a protocol should not involve any interventions that are greater than minimal risk specifically for the research.

The primary advantage of having a study designated as a Registry is that there are fewer submission requirements for the investigators. The Registry Site Information Questionnaire is significantly shorter than the standard site questionnaire and has been specifically tailored to ask questions pertinent to registry studies. A CV is not required for a registry site submission. Also, there is separate pricing for certain registry studies. Please log on to Quorum’s portal for more information on timelines and to view a registry pricelist.

To qualify as registry, a protocol should not involve any interventions that are greater than minimal risk specifically for the research. To consider a study for registry status, a sponsor must request this evaluation be completed on the initial protocol submission form.

When a principal investigator is submitting to Quorum Review IRB as part of a registry study, s/he must use a different version of the study questionnaire. PIs in a registry study must submit the Observational Registry Site Information Questionnaire. A CV is not required for a registry site submission.
Depending on the site and study, the supplemental materials (e.g., for an additional facility or audit information) may still be required.

Please contact Initial Study Support for an explanation of pricing requirements.

Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Initial Study Support at (877) 472-9883 or InitialStudySupport@quorumreview.com if you’d like more information about this process.

All proposed changes to an approved protocol or consent form(s) must be submitted by the sponsor to the Board prior to implementation. Once the Board has reviewed and approved the change to the protocol and any corresponding consent form revisions, Quorum will issue a Sponsor Letter of Amended Approval to the sponsor and Amended Approval documents to all approved/active sites in the study.

When submitting an amendment to Quorum you must include:

• Amendment Submission Coverpage
• Protocol Amendment
• Summary of changes per the Amendment (including rationale)
• Revised consent form(s), if applicable. Modifications must be incorporated into the current IRB approved consent form, using the ‘Tracking’ feature in Microsoft Word.

Amendments may be submitted via the OnQ Portal, over email to your Study Manager, or through the mail.

Amendments are reviewed at our Daily Board meeting.

Yes. Any modifications to the Protocol should be submitted to Quorum for review prior to implementation.

Please complete and return the Central Study Change Form. You may use this form to indicate primary and secondary contact changes, billing contact changes, changes in shipping preference, and acknowledgment and shipping preference changes.

You may submit this sub-study using the amendment submission process described above. On the Amendment Submission Coverpage, please indicate that only a subset of sites are participating in the sub-study and provide a list of sites and rationale.

If you’d like to get feedback on a protocol revision, a Chairperson Study Assessment can be arranged. Chairperson Study Assessments are typically a conference call arranged between the sponsor/CRO and Quorum. Chairperson Study Assessment teleconferences consist of, on Quorum’s side, the Board chair, Regulatory, Initial Study Support and Study Management.

Since protocol study tools are considered participant study materials, Quorum Review processes them as we would new or revised participant study material and a Quorum Review-approved stamped copy of the approved participant study material is sent to sites.

Revised protocol study tools should be submitted to Quorum Review for approval prior to being distributed to participants.

Revisions to consent forms must be submitted by tracking all requested changes electronically into the current Board-approved version of the consent form. Consent form revisions independent of a protocol amendment must include written rationale for each change made.

Some revised consent forms may qualify for Expedited Review. Please contact your Study Manager for more information.

A Microsoft Word version of the most current “Quorum-approved” model consent form can be found on the OnQ Portal.

No, for central studies Quorum does not require that sponsors or their representatives complete the Site Status Report on behalf of investigators. We include a sample Site Status Update Report and an investigator Periodic Site Review checklist/instruction sheet with the Protocol Continuing Review packet so you are aware of what is expected of sites for periodic review.

No, Quorum will provide investigators with Site Status Reports and a letter requesting that the report be completed for periodic site review or site closure. These materials are issued to investigators approximately four weeks prior to the Site Status Report due date as cited on the original Notice of Approval or Notice of Re-Approval issued. Additionally, Quorum staff will contact the sponsor or sponsor representative if investigators are unresponsive to our attempts at obtaining a Site Status Report.

An electronic copy of the Continuing Review Report for Protocols that includes pre-populated study information can be found on the OnQ Portal.

Please feel free to contact your Quorum Study Manager if you need assistance in completing specific questions on the Continuing Review Report for Protocols.

You can also reference Quorum’s Continuing Review Report for Protocols – Client Guidance for additional information.

Quorum considers a study closed only after all sites have submitted valid Site Status Reports for closure. If the valid closure notifications from all sites are received prior to the Protocol expiration date, the study can be closed without requiring an additional review. Please contact your Study Manager if you believe your study should be closed.

Quorum Review IRB considers a study closed at a site only if there are no actively enrolled participants and all interventions with participants have ceased. Once our closing criteria have been met, the investigator must provide formal notice of closure by submitting a “Site Status Report for closing”.

Quorum Review IRB does not consider a protocol closed until all Quorum-approved sites have been closed by the sponsor or the sponsor’s representative, submitted valid “Site Status Reports for Closing,” and been administratively closed by Quorum. Once all sites have been closed, Quorum will close the protocol. Quorum does not send sponsors written documentation of study closure.

In the rare instance that a site is unable to complete the Quorum Review IRB “Site Status Report for Closing” but the sponsor considers the site to be closed, Quorum Review IRB will accept documentation from the sponsor confirming:

• The site never initiated study activity, or the date of site closure by the sponsor or sponsor representative;
• That there are no enrolled participants at the site;
• That the site is no longer collecting data from participants; and
• The reason for non-responsiveness by the site

Please contact your Quorum Study Manager to assist you with this process.

Quorum Review IRB requests that the completed Continuing Review Report for Protocols be returned 60 days prior to the approval expiration date to allow adequate time for our staff to analyze the form and request any additional follow-up information if needed. This also allows adequate time for Board review.

Quorum will ensure your protocol is submitted and reviewed by the Board prior to the protocol expiration date. Once the protocol has been re-approved, Quorum will issue a Sponsor Letter of Reapproval to document the new approval period.

Please contact your Quorum Study Manager if you have having difficulty completing the report by the listed due date. Your Study Manager may be able to authorize additional time to complete and submit the report.

Quorum accepts submissions of Continuing Review Report for Protocolss via the web portal, email (to your Study Manager), or fax. Please remember to submit a signed version of the report.

Quorum will send a partially pre-populated “Site Status Report” form to the site approximately two (2) months before the approval expiration date. The completed form should be returned to Quorum Review IRB at least six (6) weeks prior to the approval expiration date to allow adequate time for Board review. Quorum staff follows up with investigators who have not submitted “Site Status Reports” by the due date. Quorum will fax, call, and send an expiration warning letter to the investigator (with a copy to the sponsor) in an effort to assist the investigator and avert an unintended expiration.

At the time of initial review of research, the Board establishes an approval period for the protocol. Regulations require continuing review of the research at least once per year and more frequently if determined necessary by the Board. The Continuing Review Report for Protocols is meant to capture information for the study as a whole, including information that has occurred at all Quorum and non-Quorum sites. Each investigator is also expected to complete a Site Status Report for periodic site review to report information that has occurred at their particular site.

Quorum makes every effort to ensure protocols are reviewed prior to the expiration date. If you are attempting to close a study prior to the protocol expiration date, please work with your Quorum Study Manager regarding the timing of protocol closure.

Quorum prefers written documentation from the investigator in order to close a site. In rare circumstances, if a site is being unresponsive, Quorum Review IRB will accept documentation from the sponsor confirming:

• The site never initiated study activity
• That there are no enrolled participants at the site
• The reason for non-responsiveness by the site

Please contact your Quorum Study Manager to assist you with this process.

Safety information and other reportable events can be submitted to Quorum Review IRB using the OnQ portal, fax or mail. All safety information should be submitted using the appropriate report forms found on the Quorum website. Quorum expects investigators to report safety information and other reportable events to Quorum Review IRB within ten (10) business days of becoming aware of the event’s occurrence.

Federal regulations require IRBs to collect reports of potential “unanticipated problems involving risk to participants or others” (“Unanticipated Problems”). Unanticipated Problems are events that occur during the course of a research trial that potentially increase the risk to participants or others; adversely affect the rights, safety, or welfare of participants; or affect the integrity of the study. An “unanticipated” event is one that is not identified in nature, severity, or frequency in the relevant safety documents(s) for the study product or is not identified as a possible risk in the study protocol or the informed consent form for the study.

A reportable event can occur in either a clinical setting (such as a serious and unanticipated reaction to the study drug) or a non-clinical setting (such as the loss of a laptop with study data). The event is reportable if it poses risk to research participants, research staff, or others and is possibly related to the study.

It is ultimately the decision of the Board whether a reportable event constitutes an Unanticipated Problem. In the U.S., Quorum is required to report a Board determination of an Unanticipated Problem to the FDA, OHRP or other appropriate oversight agency.

Quorum requires investigators to promptly report each of the following events within ten (10) business days of becoming aware of the event’s occurrence:

• Serious Adverse Events
• Major protocol deviations/violations
• Research participant complaints
• Adverse audit or enforcement actions (e.g., Form FDA 483, FDA Warning Letters, FDA Establishment Inspection Reports (EIRs), adverse sponsor audit findings, etc.)
• IND Safety Reports that qualify as unanticipated problems involving risk to participants or others
• New/updated safety information that may increase risk to participants
• Reports, publications, or interim results or findings
• Recalls, Withdrawals, or Clinical Holds
• Any other incident that could qualify as an unanticipated problem involving risk to participants or others, such as the loss of a laptop with confidential study data (more examples below)
• Any incident that must be reported according to the policies of the sponsor or site

For additional guidelines regarding the types of incidents that require prompt reporting, refer to the Safety Information and Unanticipated Problems Reporting Guidelines.

Quorum considers the following events to be potential Unanticipated Problems and requires investigators to promptly report each of the following events within ten (10) business days of becoming aware of the event’s occurrence:

• Serious adverse events
• Major protocol deviations/violations
• Research participant complaints
• Adverse audit or enforcement actions (e.g., Form FDA 483, FDA Warning Letters, FDA Establishment Inspection Reports (EIRs), adverse Sponsor audit findings, etc.)
• IND Safety Reports that qualify as unanticipated problems involving risk to participants or others
• New/updated safety information that may increase risk to participants
• Reports, publications, or interim results or findings
• Recalls, wthdrawals, or clinical holds
• Any other incident that could qualify as an unanticipated problem involving risk to participants or others, such as the loss of a laptop with confidential study data (more examples below)
• Any incident that must be reported according to the policies of the sponsor or site

For additional guidelines regarding the types of incidents that require prompt reporting, refer to the Safety Information and Unanticipated Problems Reporting Guidelines.

Investigators are expected to submit all safety information to Quorum unless the sponsor/CRO study contact for a multi-site study has arranged with Quorum to assume responsibility for submitting such information on behalf of the investigators.

Investigators are expected to submit all safety information to Quorum unless the sponsor/CRO study contact for a multi-site study has arranged with Quorum to assume responsibility for submitting such information on behalf of the investigators. Please contact the sponsor/CRO or Quorum’s Site Support Team if you are not sure whether the sponsor/CRO for your study has made these arrangements.

Quorum Review IRB requires sites to submit reports of Serious Adverse Events (SAEs) that meet the criteria below:

• Serious;
• Unanticipated; and
• Related to the study product or study procedures.

If an adverse event meets all three requirements, it is a reportable SAE. An “unanticipated” adverse event is one that is not identified in nature, severity, or frequency in the relevant safety documents(s) for the study product or is not identified as a possible risk in the study protocol or the informed consent form for the study. Investigators must report an SAE to Quorum Review IRB within ten (10) business days of becoming aware of the event’s occurrence. Please use Quorum Review IRB’s Serious Adverse Event Report form. An adverse event that does not meet all three reporting criteria listed above does not need to be reported to Quorum.

Quorum Review IRB requires sites to report only major protocol deviations. A “major” protocol deviation is a protocol deviation that adversely affects the:

• Safety or welfare of research participants or others;
• Rights of research participants or others; or
• Integrity of the study design

Investigators must report a major protocol deviation to Quorum Review IRB within ten (10) business days of becoming aware of the event’s occurrence. Please use Quorum Review IRB’s Major Protocol Deviation Report form.

Under Quorum’s guidelines, examples of major protocol deviations include:

• Failure to obtain informed consent
• Informed consent obtained after the initiation of study procedures
• Omitting study procedure(s) required by approved protocol
• Performing a study procedure that is not outlined in the IRB-approved protocol
• Failure to report a Serious Adverse Event
• Drug dispensing/dosing error
• Failure to securely control the study product
• Enrolling participants outside of inclusion criteria
• Failure to follow a Safety Monitoring plan
• Study visit outside of window, only if in the opinion of the investigator, if affects the safety or welfare of the research participants or others, the rights or participants or other or the integrity of the study design.
• Use of an unapproved consent form

A minor protocol deviation is a protocol violation that, in the investigator’s judgment, does not adversely affect the risk/benefit ratio of the study, the rights, safety, or welfare of the participants or others, or the integrity of the study. Examples of minor protocol deviations include:

• Study procedure conducted out of timeframe
• Study visit out of timeframe
• Participant failure to initial every page of the consent form
• Copy of consent form not given to participant during informed consent process
• Site over-enrollment
• Participant failure to return diary
• Missing original signed consent, but have a copy of the participant signed consent

Minor protocol violations do not need to be reported to Quorum Review IRB.

Federal regulations require IRBs to collect reports of potential “unanticipated problems involving risk to participants or others” (“Unanticipated Problems”). Unanticipated Problems are events that occur during the course of a research trial that potentially increase the risk to participants or others; adversely affect the rights, safety, or welfare of participants; or affect the integrity of the study. An “unanticipated” event is one that is not identified in nature, severity, or frequency in the relevant safety documents(s) for the study product or is not identified as a possible risk in the study protocol or the informed consent form for the study. A reportable Unanticipated Problem can occur in either a clinical or a non-clinical setting and is reportable if it poses risk to research participants, research staff, or others. Quorum expects investigators to report potential Unanticipated Problems to Quorum Review IRB within ten (10) business days of becoming aware of the event’s occurrence.

Quorum considers major protocol deviations and SAEs to be potential Unanticipated Problems. Additional examples of potential Unanticipated Problems that should be promptly reported include:

• Unresolved research participant complaints
• Adverse audit or enforcement actions
• Breaches of privacy/confidentiality
• Unauthorized use or disclosure of protected health information (PHI)
• Loss of study records
• Disappearance of study drug
• Research staff misconduct affecting the research
• Incarceration of a research participant
• Injury sustained by research staff relating to the study
• Suspension of principal investigator’s medical license
• Higher than expected volume of adverse events
• Higher than expected volume of protocol deviations
• Higher than expected volume of participant drop-out rates
• Complaint from a research participant involving an unanticipated risk that cannot be resolved by the research staff
• New findings that may influence a research participant’s willingness to continue participation in the study

As a general rule, no. Examples of events that generally do not need to be reported to Quorum include:

• Adverse events that, in the PI’s judgment, are not related to the study (such as a participant catching the flu);
• Adverse events that are anticipated or expected as part of the study (such as nausea in a trial of a chemotherapy drug);
• IND Safety Reports that, in the PI’s judgment, do not adversely affect the conduct of the PI’s study at his/her research facility;
• Minor protocol deviations (such as study visits performed slightly out of window);
• Minor research participant complaints that are adequately resolved by the research staff.

At the time of periodic site review, Quorum Review IRB’s “Sites Status Report for Periodic Site Review” will ask whether the investigator believes that a change in the research plan or the consent form is necessary in light of these unreported events. If the investigator recommends a change in the research or the consent form, Quorum Review IRB might request that the investigator submit the log or other summary of adverse events and protocol deviations for further consideration.

Quorum Review IRB recognizes that sponsors, site monitors, CROs or sites may have broader reporting requirements than Quorum’s. You can go ahead and submit such reports. Quorum Review IRB will provide a standard acknowledgement of all documents submitted to fulfill such sponsor and site requirements.

Quorum Review IRB recognizes that sponsors, site monitors, CROs or sites may have broader reporting requirements than Quorum’s. You can go ahead and submit such reports. Quorum Review IRB will provide a standard acknowledgement of all documents submitted to fulfill such sponsor and site requirements.

Under Quorum’s guidelines, the vast majority of IND Safety Reports, MedWatch Reports and CIOMS Reports (“Reports”) do not need to be reported to Quorum Review. The only Reports that must be submitted are those that qualify as potential unanticipated problems involving risk to participants or others.

We understand that a number of sponsors and sites have SOPs that require transmission of all Reports to the Board regardless of the nature of the incident reported. If you are submitting a Report to fulfill such a requirement, you can so indicate on the cover page. You will receive an acknowledgment of receipt by Quorum.

If you are submitting multiple IND Safety Reports (or other events) at the same time, we encourage you to include a cover letter listing all of the reports included in the submission.

For centralized multi-site studies, Quorum Review IRB requests that sponsors submit the following documents on behalf of the investigators:

• Investigator Brochures
• Package Inserts
• Device Manuals

When Investigator Brochures, Package Inserts, and Device Manuals are revised, Quorum Review IRB requires sponsors to submit a summary of changes along with the revised document to Quorum Review IRB on behalf of all investigators at the same time these revised documents are sent to investigators. In addition, it is especially helpful to provide a tracked version of the document showing the changes made.

For centralized multi-site studies, Quorum Review IRB requests that sponsors submit the following documents on behalf of the investigators:

• Investigator Brochures
• Package Inserts
• Device Manuals

Quorum requires submission of an IB for the initial review of every IND protocol. The IB is important to the review of a protocol, in that it provides information that is necessary to assess the overall risks and benefits of the research; however, Quorum Review does not “approve” or “disapprove” this document.

Should the IB be updated during the course of a study, acknowledgement of the revised document is provided to the sponsor and all active sites, if requested by the sponsor, in order to document that Quorum Review has been adequately notified of additional safety information provided since the initial review.

A protocol “waiver” or “exception” is an intentional deviation from the approved protocol, such as the enrollment of a participant in violation of the protocol’s inclusion/exclusion criteria. Most sites realize that it is necessary to obtain the sponsor’s approval prior to implementing a protocol waiver. It is also necessary, however, to obtain the IRB’s approval prior to implementing a protocol waiver, unless the change is deemed necessary to eliminate an apparent immediate hazard.

All requests for protocol waivers should be submitted to Quorum on Quorum’s Prospective Waiver Request Form. Quorum will ask for documentation of the sponsor’s approval and each request will be submitted to the Board. Such requests typically are typically processed through Quorum’s expedited Board reviewers.

All requests for protocol waivers should be submitted to Quorum on Quorum’s Prospective Waiver Request Form. Quorum will ask for documentation of the sponsor’s approval and each request will be submitted to the Board. Such requests typically are processed through Quorum’s expedited Board reviewers.

Please submit a protocol deviation report to notify Quorum of changes made from the approved protocol without prior approval. The change is reportable if it meets the reporting criteria for major protocol deviations.

Please submit a protocol deviation report to notify Quorum of changes made from the approved protocol without prior approval. The change is reportable if it meets the reporting criteria for major protocol deviations.

A standard acknowledgment is an acknowledgement of receipt. Quorum Review IRB will stamp the first page of a submitted safety report with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator. Please note that standard acknowledgment represents receipt only; the standard acknowledgement does not represent Board review of the reported information. The Board will send a separate notice if it is determined upon review that additional action is necessary. In a multi-site study in which a number of investigators submit duplicate information (such as IND Safety Reports), Quorum will return a standard acknowledgment to each investigator who sends a submission.

A standard acknowledgment is an acknowledgement of receipt. Quorum Review IRB will stamp the first page of a submitted safety report with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

Please note that standard acknowledgment represents receipt only; the standard acknowledgement does not represent Board review of the reported information. The Board will send a separate notice if it is determined upon review that additional action is necessary. In a multi-site study in which a number of investigators submit duplicate information (such as IND Safety Reports), Quorum will return a standard acknowledgment to each investigator who sends a submission.

A sponsor acknowledgement is provided when a sponsor chooses to assume sole responsibility for submitting to Quorum Review IRB study-level safety information and Reportable Events (such as IND Safety Reports, Investigator Brochures, Package Inserts, and Device Manuals). Even if the sponsor assumes this responsibility; however, Quorum Review IRB will generate the acknowledgement letter upon receipt of the initial report without regard to who submitted it.

Quorum Review IRB will generate only one receipt letter per report, even if Quorum Review IRB receives multiple copies of the report. In addition, Quorum Review IRB will generate a standard stamp acknowledgement for each investigator who submits a copy of the report.

Quorum Review IRB provides sponsors with two types of acknowledgement for Safety Information and Unanticipated Problems:

• Option one – sponsor acknowledgment only: Quorum Review IRB sends the receipt letter to the sponsor only. The sponsor then accepts responsibility for distributing acknowledgments to the sites as necessary.
• Option two – study-wide acknowledgment: Quorum Review IRB distributes receipt letter to each site that is open at the time of receipt. For this service, Quorum Review IRB will charge on a per site basis.

When Quorum Review IRB is reviewing a study on a single-site basis, Quorum Review IRB will always send the Standard acknowledgment as described above. When Quorum Review IRB is acting as a central Ethics Review Board, the sponsor determines the type of acknowledgement investigators will receive for study-wide reports at the time of protocol submission. The sponsor makes this choice on the “Central Study Questionnaire” (CSQ).

You can change your acknowledgement preferences by submitting the Central Study Information Change Request Form at any time throughout the course of the study. For more information about acknowledgment options or changing acknowledgment preference contact your Study Manager.

Quorum Review IRB does not send formal acknowledgement letters for site level safety Information. Quorum sends standard acknowledgements for site level safety information or Unanticipated Problems. Quorum Review IRB will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

Quorum will issue an acknowledgement letter to the site when a revised Investigator Brochure is received. When all other safety information is received, such as Protocol Deviations, IND safety reports, Serious Adverse Event reports, and reports of Unanticipated Problems, Quorum will issue a standard acknowledgment. In the case of a standard acknowledgement, Quorum will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

Please see the Study Start-Up Process section of the site for forms and information about getting started. Feel free to contact us with any questions.

The institutional review board/research ethics board currently meets on Tuesday, Wednesday, Thursday and Friday of each week, excluding major holidays (see the Quorum Review Board Meeting Schedule for exact dates) for the initial review of all protocols and consent forms. Quorum also has a daily Board that meets to review amendments and major consent form changes.

Submission deadlines are 5:00pm Pacific Time, each Tuesday, Wednesday and Friday, one week prior to the meeting at which you wish to have your materials reviewed. 

For example, all completed material received by Tuesday will be scheduled for the Board meeting on the following Tuesday. All completed material received by Friday will be scheduled for the Board meeting on the following Friday. 

Submission deadline for daily meetings is close of business two days prior. 

All required submission elements must be received before an item can be scheduled for Board review. 

Please note that some items may qualify for Expedited Review. Feel free to contact your Study Manager for more information about Expedited Review.

Site submission deadlines are 5:00pm Pacific Time, every weekday. Please contact Initial Study Support, Site Support or log in to the OnQ Portal and see Quorum’s IRB/REB Meeting and Review Cycle Timing sheet for more information on timelines.

Yes. Quorum Review IRB maintains an ethics review board (referred to as the “North American” Board) and serves as a duly convened research ethics board (REB) and central institutional review board (IRB). The North American Board complies with applicable regulatory requirements and meets every Wednesday to review U.S. and Canadian studies. Quorum is AAHRPP-accredited and accepts both privately and publically funded research in Canada. Read more about our North American review here, or contact us for more information.

Yes. Quorum’s North American Board is an institutional review board/research ethics board that meets on Wednesdays and is authorized to review research involving Canadian sites. Some Canadian sites may qualify for a daily review of sites; other site and protocol reviews will be scheduled for the North American meeting. Read more about our North American review.

Quorum will send notification of pending expiration to the primary study contact approximately 75 days before study approval is due to expire. To renew study approval, please submit a completed Protocol Continuing Review Report at least 60 days prior to the study expiration date. 

Quorum will send notification of pending expiration to all active sites under Quorum’s jurisdiction approximately 75 days before the site’s approval is due to expire. All sites scheduled to remain active after the last day of their current approval period must submit a completed Site Status Report at least 45 days before their expiration date. All sites scheduled to close before the last day of their current approval period must submit a completed Site Status Report prior to their expiration date. 

All sites that do not submit a completed report before their expiration date will be scheduled for consideration of suspension and, potentially, termination by the Board. (Please see the Continuing Review and Site Closure FAQ for more information)

Quorum will send notification of pending expiration approximately 75 days before your site’s approval is due to expire. If your site is scheduled to remain active after the last day of your current approval period, you must submit a completed Site Status Report at least 45 days before the expiration date. If your site is scheduled to close before the last day of your current approval period, you must submit a completed Site Status Report prior to your expiration date. If a Report is not received by the due date, IRB/REB approval may expire. A Board finding of continuing noncompliance may be reported to the study sponsor and the FDA.

Quorum requires review of all changes in research activity, including protocol amendments and/or consent form revisions. Quorum offers a cover sheet to assist with submitting an amendment.

Please submit the following required information, at minimum, to your Study Manager:

• Cover letter
• Summary of changes
• Rationale for changes
• Full text of amendment or amended protocol
• Tracked, electronic copy of consent form(s), (if applicable)

All consent form revisions must be tracked in electronically using the current, Board-approved version of the consent form. Some protocol amendments may qualify for Expedited Review. Please contact your Study Manager for more information.

Quorum does not require the submission of or acknowledge receipt of a revised Form FDA 1572. Instead, Quorum’s Change Request Form for Sites is the best way to report to Quorum any changes in your site’s address, contact information, study coordinator or participant compensation. Quorum’s Change in Primary Facility Form and Principal Investigator Change Form allow you to submit major changes. Please take a look at our Instructions for Submitting Study Site Modifications to Quorum Review for guidance on the use of the change forms and any additional requirements for documentation. Contact Quorum’s Site Support Team for assistance at 1-877-IRB-9883 or sitesupport@quorumreview.com.

The Board will review the information you submit and, if appropriate, issue a new consent form.

Revisions to consent forms must be submitted by tracking all requested changes electronically into the current Board-approved version of the consent form. Consent form revisions independent of a protocol amendment must include written rationale for each change made. Quorum offers a cover sheet to assist with submitting revised consent forms.

Quorum requires prompt reporting of all Major Protocol Deviations/Violations and Serious Adverse Events and Unanticipated Problems that occur at the investigator’s site. Notification of IND safety reports, Investigator Brochures, Device Manuals, Package Inserts, FDA Safety Alerts and other protocol level safety documents is required as arranged previously with the study sponsor. Quorum requires the use of its forms when submitting safety information.

For detailed guidance on submitting safety information refer to the Reporting Safety Information and Unanticipated Problems guidance document. Please do not hesitate to contact us with any questions.

The Board reviews consent forms for compliance with regulatory requirements and consistency with protocol information, as well as for grammar, formatting, and readability. Please contact us if you would like to receive a sample consent form to review. You also can review our complete set of template consent forms and guidelines in the Quorum Handbook © or the Quorum Web Portal.

All material intended for use in the recruitment of potential study participants must be reviewed and approved by the Board prior to use. These materials include, but are not limited to, advertisements in newspapers, television, radio, bulletin boards, posters, flyers and Internet postings.

For detailed guidance on submitting recruitment material to Quorum, please see our Guide to Recruitment and Participant Study Materials.

Please see our local law document.

Changes to the content of a consent form, outside of site specific contact information, that are not submitted by the sponsor are considered “unique changes.” Unique changes may include the addition of a Witness Statement, language added/modified to fulfill state law requirements, or other changes to the wording of the consent form.

All unique consent form changes must be tracked into an electronic copy of the current Board-approved version of the consent form and submitted electronically. For central studies, requests for unique consent form changes must be accompanied by rationale and documentation of sponsor approval for the change. Failure to submit unique changes in the appropriate format or with the necessary sponsor authorization will result in delays in review.

Revised consent forms will be reviewed according to regular submission deadlines (see the Quorum Review Board Meeting Schedule). Some revised consent forms may qualify for Expedited Review. Please contact Quorum’s Site Support Team at 1-877-IRB-9883 or sitesupport@quorumreview.com for more information.

Upon request, Quorum will obtain a translated consent form for use in consenting a participant in his/her first language. Each site that wishes to use a non-English consent form must be specifically approved to do so. Please contact your Study Manager to further discuss your translation options.

Upon request, Quorum will obtain a translated consent form for use in consenting participants in their first language. All sites who wish to use a non-English consent form must be specifically approved to do so. To request a translation, please complete a Change Request Form for Sites. Contact Quorum’s Site Support Team for assistance at 1-877-IRB-9883 or sitesupport@quorumreview.com with the following information.

Participants must be informed in the informed consent document regarding the limitations and protections of the Certificate of Confidentiality. Please notify Quorum Review IRB if you have requested or will be requesting a Certificate of Confidentiality. Also note that if a Certificate of Confidentiality is obtained after the study has commenced, the consent form will need to be revised in order to inform subjects about the Certificate, including its limitation and protections.

Please contact Quorum Review IRB if you have questions regarding what type of language needs to be included in the consent form. If Quorum is notified that a Certificate of Confidentiality has been or will be obtained, Quorum can also include standard template language in the consent form.

Please download our local law document.

All questions can be directed to your Study Manager. We take pride in our single point of contact system that enables you to route all questions through a single individual who is responsible for all aspects of a study. For general questions you can always contact us.

All questions can be directed to Quorum’s Site Support Team at 1-877-IRB-9883 or sitesupport@quorumreview.com.

Quorum recommends submitting participant recruitment or participant study materials along with the Recruitment and Participant Study Materials Cover Page. Providing this document allows us to easily determine exactly what is being submitted, so we may properly route your items for processing. Failure to provide this document may result in a delay.

Participant Recruitment materials include:

• Printed materials: advertisements in newspapers, bulletin boards, posters, flyers, brochures, press releases, “Dear Patient” letters (for recruiting purposes), informational articles for recruitment purposes, newsletters, study synopses, etc.
• Audio/Video materials: radio scripts and recordings, public service announcement scripts and recordings, telephone screening scripts, television scripts and recordings, etc.
• Internet materials: Websites, Internet screening, banner ads, etc.

Participant study materials include:

• Diaries, instructions, and medication logs
• Other written instructions (for following study procedures, using study devices, following study dietary requirements, etc.)
• Participant information letters
• Appointment reminder cards, emergency unblinding cards

Protocol study tools include:

• Summaries of the study screening procedures
• Agreements to comply with study procedures or requirements
• Protocol-required questionnaires, surveys, and medical guidelines

A Protocol Study Tool is a type of participant study material generated by the sponsor that is also described in the protocol as being given to participants as part of the study procedures and is generally used to collect study data. Protocol study tools that are included in the body of the protocol are reviewed as part of the protocol. Protocol study tools that are not part of the protocol or that are identified as appendices are reviewed as participant study material. Since the study tools are reviewed as participant study material, a “Quorum Approved” stamped copy of the protocol study tool is included with the approval document.

Quorum accepts HIPAA Waiver/Alteration Requests via the OnQ Portal, email to our Initial Study Support team, fax, or mail.

Quorum Review
Initial Study Support Team
1601 Fifth Ave., Ste. 1000
Seattle, WA 98101
Fax: 206-448-4193
InitialStudySupport@quorumreview.com

A complete HIPAA waiver allows an investigator to use and disclose PHI for a particular research trial or activity without obtaining either a verbal or written authorization from the participants. A partial HIPAA waiver allows an investigator to obtain, use, and/or disclose PHI for one specified portion of a research trial or activity (e.g., in the course of recruitment) without first obtaining a verbal or written authorization.

An alteration allows an investigator to have any of the 6 specific core elements or 3 required statements removed from the requirement of HIPAA authorization. For example, a study has been approved with a waiver of documentation of consent. In order for participants to not have to sign an authorization, the investigator or sponsor will need to request an alteration in order to remove the HIPAA requirement to obtain the signature of the individual and date.

A request for a complete waiver, a partial waiver, or an alteration is completed on all one form: the Request for Waiver or Alteration of HIPAA Authorization Requirement.

IRBs and Privacy Boards coexist. Therefore, the HIPAA Privacy Rule allows a covered entity to use or disclose PHI based on an authorization or alteration approved by any IRB or Privacy Board, without regard to the location or affiliation of the IRB or Privacy Board. An investigator that is a covered entity has the right to rely on any IRB’s or Privacy Board’s documentation granting a waiver or alteration of the Authorization requirement so long as the documentation is proper. However, please note that if you are an investigation that is affiliated with an institution or hospital, they may require review and approval of any waiver/alteration before allowing the use or disclosure of PHI held by that institution or hospital.

Our Initial Study Support team should be contacted with any questions regarding a HIPAA waiver requests. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.

An investigator may need to obtain, use, or disclose PHI in the course of recruitment activities without first obtaining a written authorization. For example: an investigator wants to conduct telephone screens of potential study participants who are responding to an advertising campaign; an investigator (who is not a member of the workforce of the covered entity) wishes to record PHI obtained from patient charts and then contact those patients to determine if they may be interested in enrolling in the research. Quorum Review IRB encourages investigators to seek partial waivers in conjunction with such recruitment activities.

Quorum Review IRB discourages investigators from recruiting participants with “cold calls” based on information derived from the medical records of another practitioner when the investigator has no prior relationship with the recruits. Instead, Quorum Review IRB recognizes the ability of a practitioner to discuss with his or her own patient the possibility of participating in clinical research studies. When an investigator seeks a HIPAA waiver/partial waiver for recruitment activities that include “cold calls” to potential recruits, Quorum Review IRB prefers that potential recruits be contacted only by individuals who have been actively involved in providing health care to the potential recruits.

An investigator must proceed with recruiting carefully in light of the HIPAA Privacy Rule as well as state laws that may prohibit the release of PHI without written authorization. Some states may not allow an exception to confidentiality laws for purposes of recruitment into a research study. This is true even though the federal HIPAA Privacy Rule technically allows partial waivers for recruitment purposes.

No. Aside from HIPAA Authorizations incorporated into consent forms (i.e. “blended consent”) and HIPAA waiver/alteration requests, Quorum Review IRB will not review HIPAA compliance documents developed by the investigator. This includes stand-alone HIPAA authorizations.

If the model consent does not contain a HIPAA section, your site needs to present a HIPAA authorization according to your site’s requirements. The Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) requires investigators who are “covered entities” to obtain a HIPAA Authorization from each participant in a research trial. Obtaining a HIPAA Authorization from a research participant allows the investigator to use and disclose the participant’s protected health information (PHI) for research purposes.

If you have determined that you (as a researcher) and/or your site is not a covered entity and documented this analysis, you are not subject to the HIPAA Privacy Rule. However, state laws concerning confidentiality and disclosure of PHI, medical information, medical records, and/or genetic information will still apply. You are responsible for complying with any applicable state laws. Investigators are encouraged to seek legal counsel in order to ensure that he/she is in compliance with applicable state laws.

• For one investigator/site
• For all investigators in a study
• For a subset of investigators in a study
• For sponsor use at the national or regional level
• For generic use, not associated with a specific study

Yes, any gifts that will be given to participants should be submitted to Quorum for review.

Investigators may submit generic materials that are not associated with a specific study to Quorum Review for review and approval for generic use. If you think you have recruitment material that would qualify for the Generic Material Review option, contact Quorum and ask to speak to a Recruitment Specialist for more information about this option.

Some sponsors require sites to obtain sponsor/CRO approval for recruitment and participant study materials prior to use. In this case, Quorum requires written documentation from the sponsor or CRO indicating approval. This can be in the form or a letter or email and can be forwarded to Quorum from the site contact.

Materials that are “approved with modifications” by the Board must be resubmitted to Quorum with the requested modifications. The Board will verify these modifications prior to Quorum issuing an approval letter. If materials come back with changes in addition to modifications requested by the Board, Quorum considers the document to be a new submission and will result in additional charges as identified in the Quorum pricelist and could require sponsor approval, depending on the requirement of your sponsor.

Quorum recommends that scripts are submitted for review before production of the recording is started.

• After the script has received Board approval and the ad has been recorded, the final recording must be submitted for review prior to broadcast.
• After approval, radio scripts for live broadcast use must be read exactly as approved.

Please visit the FAQs for HIPAA under “Additional Services.”

Quorum offers translation services in over 100 languages and dialects for all study related documents, including recruitment and study materials. Please contact the Site Support Team if you would like more information regarding these services.

According to recruitment guidelines, internet listings where the system format limits the information provided to basic trial information, such as the title; purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and how to contact the site for further information do not require review.

If you are unsure if something requires review or not, you can submit a copy of the material to Quorum and ask to have a Recruitment Specialist analyze the listing to determine if your item requires review prior to use. If it is determined that the item does not require IRB review, our Recruitment Specialist will then send you a fax documenting the material does not require IRB review.

Yes, changes to previously approved recruitment or participant study materials should be submitted to Quorum Review IRB for approval prior to implementing the change. 

Spelling corrections and changes to site specific contact information as indicated with space holders are allowed without additional approval from Quorum Review. If no space holders are present, the advertisement should not be modified.

Changes in size can be made provided that the changes are made to scale relative to the original approved material.

Recruitment and Participant Study Materials can be submitted to Quorum Review IRB using the OnQ Portal, fax or mail. If you have additional questions about an advertisement submission contact the Site Support Team for assistance.

Revised recruitment and participant study material intended to replace a previous version are identified as “Replacement Material” on the approval document. Approval for the new version will replace approval for the previous version.

Model and Mini Model Materials: A study sponsor may submit model participant recruitment and participant study materials on behalf of all or some of the investigators participating in a protocol. These materials may be approved without investigator-specific contact information, which can be added by the investigator after approval. Generally, model participant recruitment and participant study materials are reviewed by the Board and approved for use by all investigators in a study. However, a sponsor can identify a subset of investigators to use particular participant recruitment and/or participant study materials which will be approved as mini-model materials.

Participant Study Materials : Consistent with the review of participant recruitment materials, the Board requires the review of participant study materials to ensure that the materials are not unduly coercive or misleading and do not promise a certainty of cure beyond what is outlined in the consent and the protocol. “Quorum-approved” stamped copies of these materials are included with the approval document.

Protocol Study Tools: A “protocol study tool” is a type of participant study material generated by the sponsor that is also described in the protocol as being given to participants as part of the study procedures and is generally used to collect study data. Protocol study tools that are included in the body of the Protocol are reviewed as part of the protocol. Protocol study tools that are not part of the protocol or that are identified as appendices to the protocol will be reviewed as participant study material. Since the study tools are reviewed and cited as participant study material, “Quorum approved” stamped copies of these materials are included with approval documents.

Prior to March 1, 2010, protocol study tools were considered part of the protocol, and Quorum processed them as we would the protocol or any amendments to the protocol. We issued approval for the material on Notice of Approval documents for protocol study tools that were reviewed with the initial protocol submission and we issued approval on Amended Approval documents for protocol study tools that were approved during the course of a study. We did not distribute Quorum Review-approved stamped copies of protocol study tools to sites as we did not issue Quorum Review-approval stamped copies of the protocol to sites.

Protocol study tools submitted after March 1, 2010, will be processed as participant study materials and a “Quorum Approved” stamped copy of the protocol study tool will be provided with the approval document.

A participant retention program is a program that involves the provision of gifts or other incentives to enrolled participants to encourage their continued participation in a study. As an example, an investigator might offer $20 gift cards to participants who reach a particular study visit milestone. Or, a sponsor might provide inexpensive gifts (e.g., tote bags, pens, t-shirts, mugs, etc.) throughout a study. All participant retention materials must be submitted for review.

A study sponsor may submit recruitment materials to be used by the sponsor at the national or regional level. These materials can only be approved with sponsor contact information that is not specific to the investigator. National or regional recruitment and study materials will be reviewed by the Board and approved for use by the sponsor.

• Sponsor will be responsible for running and maintaining the campaign
• Sites will not receive approval for the materials from Quorum
• Materials must be submitted in final format
• No site-specific contact information or placeholders for site contact information (with the exception of a centrally managed site location listing) Examples: Recruitment materials containing 1-800 numbers for sponsor-run call centers or sponsor-run websites

An investigator or sponsor/CRO/SMO may submit generic materials that are not associated with a specific study to Quorum Review for review and approval for generic use. The approval period for generic material is one year, with automatic annual review of the material. A courtesy notification of annual review will be sent prior to the annual review date. Annual review occurs until notification is received to cancel the annual review process.

• Generic advertisements such as brochures, print ads, web ads, or posters
• Generic telephone screening scripts
• Generic ads do not contain study-specific information
• The approval period for generic materials is one year. Materials will be annually re-reviewed automatically, unless correspondence is received to cancel the annual review process.
• Standard review fees apply for each annual review that occurs
• Materials must be submitted in final format
• Changes to approved generic material must be reviewed and approved prior to use

Generic Material Submissions require the Generic Material Submission Form.

When submitting a study to Quorum, sponsors have the option to require all site recruitment and participant study material to receive a written individual approval from the sponsor before being reviewed. If a sponsor chooses this option and a site submits materials without sponsor approval Quorum will contact the site to request sponsor approval before proceeding with the review of the materials.

If you would like to change your preference from what was indicated on your Central Study Questionnaire, please contact your Study Manager.

Submitting recruitment or participant study material along with initial protocol or site submission materials reduces cost. Submitting materials this way reduces cost because there will be no charge for the review and preparation of all site approval documents.

If you are unable to submit recruitment and study materials along with the protocol and consent form, attempt to submit them either before sites have been reviewed or with as few sites approved as possible. (Sites that already have approvals will accrue additional charges when Quorum Review IRB prepares the approval documents for those sites; sites that don’t yet have approval will receive approval for those materials with their ICF and Notice of Approval documentation). An alternative would be to submit as a mini model ad if only a certain subset of investigators will require the material.

Please visit the FAQs for HIPAA under “Additional Services.”

Quorum offers translation services in over 100 languages and dialects for all study related documents, including recruitment and study materials. Please contact your Study Manager if you would like more information regarding these services.

According to recruitment guidelines, internet listings where the system format limits the information provided to basic trial information, such as the title; purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and how to contact the site for further information do not require review.

If you are unsure if something requires review or not, you can send a copy of the material to your Study Manager and ask to have a Recruitment Specialist analyze the listing to determine if your item requires review prior to use. If it is determined that the item does not require IRB review, our Recruitment Specialist will then send you a fax documenting the material does not require IRB review.

Yes, changes to previously approved recruitment or participant study materials should be submitted to Quorum Review IRB for approval prior to implementing the change.

Spelling corrections and changes to site specific contact information as indicated with space holders are allowed without additional approval from Quorum Review. If no space holders are present, the advertisement should not be modified. If no space holders are present, the advertisement should not be modified.

Changes in size can be made provided that the changes are made to scale relative to the original approved material.

Recruitment and Participant Study Materials can be submitted to Quorum Review IRB using the OnQ portal, fax or mail. If you have additional questions about an advertisement submission contact your Study Manager for assistance.

Quorum asks that all Study-related correspondence is delivered through the designated contacts for the study. In the case of third party vendors and Advertising Agencies, it may be possible for these groups to submit recruitment materials but please provide written authorization from the primary study contact indicating that this person/company may submit materials on behalf of the sponsor.

Revised recruitment and participant study material intended to replace a previous version are identified as “Replacement Material” on the approval document. Approval for the new version will replace approval for the previous version.

As of March 1, 2010, Sponsors will receive an approval letter for approved model recruitment and participant study material reviewed after study start up. The approval letter will contain a “Quorum Approved” stamped copy of approved material.

Model recruitment and participant study material approved during study start up will be cited on the Sponsor’s Letter of Approvability. A “Quorum Approved” stamped copy of the material will not be provided to the Sponsor at this time.

Yes. Quorum has a form called the Observational Registry or Qualified Minimal Risk Site Status Report used for periodic site review or closure. This form is available on Quorum’s website. Quorum will also send a copy of the Observational Registry and Qualified Minimal Risk Site Status Report prior to the site’s anniversary.

Periodic Site Review is a review that occurs prior to your study expiration date. If you plan to continue to conduct your study after your expiration date listed on your Notice of Approval (or Notice of Re-Approval), then you will need to submit a Site Status Report for periodic site review.

Quorum considers a site to be closed when all of the following criteria have been satisfied:

• You have no enrolled participants.
• You are no longer collecting data from participants.
• Your sponsor or the sponsor’s representative considers you closed.

If your site does not meet all of these requirements, Quorum does not consider you closed. If you do not meet these requirements but your sponsor does consider you closed, please contact Quorum for further guidance on this matter.

If you meet the requirements for closing (see criteria above), you should complete a Site Status Report for Closing and submit it to Quorum. If you do not meet all the requirements for closing, and will not meet them before the expiration date listed on your Notice of Approval (or Notice of Re-Approval), then you will need to submit a Site Status Report for periodic site review. 

Please note that if a Site Status Report is not received by the IRB approval expiration date, IRB approval to conduct your study will expire. Be advised, conducting research activities without IRB approval is a violation of federal regulations. Furthermore, failure to provide a Site Status Report for Periodic Site Review or Closing may lead to a finding of serious or continuing noncompliance which requires notification to the U.S. Food and Drug Administration.

If you are closed, or planning to close before your IRB expiration date, you should complete a Site Status Report for closure and submit it to Quorum. If you don’t expect to close until after your expiration date, you should remain open and submit a Site Status Report for periodic site review. If the sponsor or sponsor representative will be closing your site a couple of days prior or on your expiration date, Quorum suggests you send in a Site Status Report for Periodic Site Review to prevent site expiration.

Please note that if a Site Status Report is not received by the IRB approval expiration date, IRB approval to conduct your study will expire. Be advised that conducting research activities without IRB approval is a violation of federal regulations. Furthermore, failure to provide a Site Status Report may lead to a finding of serious or continuing noncompliance which requires notification to the U.S. Food and Drug Administration.

Closed: You have no active enrolled participants, you are no longer collecting data from participants and your sponsor or the sponsor’s representative considers you closed. 

Closed to Enrollment: Your site is no longer enrolling new participants into the study. However, you may still have active participants in the study and/or other study activity may still be taking place. Please DO NOT submit a Site Status Report indicating your site is closed when your study is just closed for enrollment. Doing so could result in Quorum Review closing your file prematurely and may require a new site submission.

Not Yet Initiated:
Your site has not yet been initiated for this study by the sponsor, but you still plan to participate in the study.

Active:
Your site is currently actively participating in the study and enrollment is still open.

Active – enrollment is closed: 
This study is still open at your site, but you are closed to enrollment.

Generally, a screen failure is someone who does not get enrolled into the study for various reasons, documented during the screening process. Screen failures signed the consent form and may have had screening procedures but did not undergo any other study procedure.  Reasons for the participant to fail screening may include, but are not limited to, the participant not meeting inclusion criteria or meeting exclusion criteria (ineligibility). Your sponsor or protocol may define a screen failure differently.

A “participant who withdrew” is a participant who either:

1)  stopped the study before completing the full schedule of study visits (including follow-up),
- OR -
2) who transferred sites.

Some protocols may have a variable number of visits and consider participants as completing, rather than withdrawing, in the case of disease progression or similar clinical outcome. In such cases, the protocol definition should be followed, with the withdrawal category reserved for participants who withdrew for other reasons.

Since death is considered an adverse event, such participants should be listed in question 5. To determine if the death is an SAE (Serious Adverse Event) and reportable to Quorum, please refer to the Safety Information and Unanticipated Problems Reporting Guidelines Form.

Sometimes participants transfer to other sites because they move or because a site may stop doing the study. If a participant transfers away from your site to another site, they should be counted as a participant who dropped or withdrew early. 

If a participant transferred to your site from another site, please include this participant in the question asking for the total number of participants who signed a consent form throughout the course of this study. (see question 3 in Section Two).

Participants who are “currently active” in the study have not dropped early nor have they been terminated.

These are participants who have not yet completed the study. Participants who are currently active in the study include:

• Participants who still come to the site for study visits or still receive study product.
• Participants in follow-up (with or without study visits) even if a participant has no other involvement with the study.
• Any other participant who is still in the study. 

Please submit the advertisement that was used, a letter of explanation, and a completed Protocol Deviation (Major)/Violation Report form to Quorum with your Site Status Report.

In your letter of explanation, please indicate whether or not you would like Quorum to review the advertisement and give approval for its future use and provide a plan for corrective action to prevent this from occurring in the future.

Please submit the translated consent form that was used, a letter of explanation, and a completed major protocol deviation/violation form to Quorum with your Site Status Report. 

In your letter of explanation, please indicate if you wish to receive a Quorum-approved translated consent form for future use and provide a plan for corrective action to prevent this from occurring in the future. You must indicate what language you want the consent to be translated into and who at your site is fluent in that language.

Quorum defines a Major Protocol Deviation/Violation as any intentional or unintentional change from the IRB-approved protocol that adversely affects the risk/benefit ratio of the study; the rights, safety, or welfare of the participants or others; or the integrity of the study. Please refer to the Safety Information and Unanticipated Problems Reporting Guidelines for more information.

Quorum defines a Serious Adverse Event as any event that is serious, unanticipated, and related to the study product/procedures. Please refer to the Safety Information and Unanticipated Problems Reporting Guidelines for more information.

Quorum defines an Unanticipated Problem as any problem that adversely affects – the risk/benefit ratio of the study; – the rights, safety, or welfare of the participants or others; or – the integrity of the study. Please refer to the Safety Information and Unanticipated Problems Reporting Guidelines for more information.

Yes. Any major Protocol Deviations/Violations or Serious Adverse Events not yet reported to Quorum must be submitted with the Site Status Report for Periodic Site Review or Closing.

Please refer to the Safety Information and Unanticipated Problems Reporting Guidelines for more information about Major Protocol Deviations/Violations and SAE reporting requirements. If you have not submitted Major Protocol Deviations/Violations or Serious Adverse Events to Quorum for a particular study, please do so immediately. If you are uncertain if you have already reported them, or if we have received them, please contact Quorum to verify their receipt.

Usually not. Quorum requires sites to submit an analysis of Adverse Events, Minor Protocol Deviations and other Minor Unanticipated Problems that have not been reported to Quorum Review only if in combination they adversely affect the risk/benefit ratio of the study; the rights, safety, or welfare of the participants or others; or the integrity of the study. Quorum does not review individual event reports or line listings of Minor Deviations, Adverse Events, or Minor Unanticipated Problems.

Community attributes or conditions that could affect medical research include (but are not limited to) religious attributes within the local population or recent media reports on clinical studies that may have affected public opinion about medical research.

Please contact your legal counsel for updates and interpretations of local and state law.

Training which qualifies as “Human Research Participant Protection Training” includes (but is not limited to) classes, on-line seminars, and self study about the rights and protections of human research participants. 

Quorum expects principal investigators to be responsible for the conduct of research trials and all associated research facilities consistent with the IRB-approved protocol, applicable law and regulations, applicable federal and ICH Guidelines for Good Clinical Practice, and ethical principles of the Belmont Report.

Yes, if you have not previously submitted this letter to Quorum for consideration in this study. Quorum requires all documentation of FDA audits of the principal investigator, sub investigators, and research facilities to be submitted.

Please include a memo stating that no results from the audit have yet been received and include any notifications for audit or correspondence with the FDA leading up to the audit with your Site Status Report. Once you have received the audit results, please submit them to Quorum for review.

You should list the most current English main/core Quorum-approved study consent form received by your site from Quorum (question 23). Please do not list consent forms such as Translated, Addendum, Assent, Pharmacogenetic or Pharmacokinetic consent forms.

Please use the version and date listed in the footer (often on the left hand side) of the main consent form (e.g. “Version 1, dated 01/01/00″). Do NOT use the “Quorum Approved” date, which is often stamped on the lower right-hand side of the consent form. 

The “Version Date” is the date the consent form was originally reviewed by Quorum for use in the study. 

The “Quorum Approved” date is the date that Quorum-approved your site to use the consent form.

If no participants have been enrolled at your site for this study, indicate in question 23 the most current English main/core Quorum-approved study consent form you have received for this study from Quorum and complete Question 24A and 24B stating that no participants have been enrolled in this study.

No. You only need to list the most current English main/core versions of the consent form. You do not need to list translated versions of the consent form or addenda.

No, listing the version and date of the current consent form on the Site Status Report is sufficient. Quorum can verify this internally for discrepancies.

Yes. Please indicate on question 23 the most current English main/core study approved consent form received from Quorum by your site. Please answer questions 24A and 24B indicating that no participants have signed the updated version and state the reason why. If participants have signed a previous version of the consent form for this study, please answer question 24C.

If you have changed any of the information covered by question 26 and it has not yet been reported to Quorum, then you must submit a completed Change Request Form for Sites) and any accompanying documents noted on the form.

Writing your changes on the Site Status Report or attaching a brief letter of explanation is not acceptable, and these changes will not be made unless submitted to Quorum on a completed Change Request Form for Sites.

If you have already submitted changes at your site to Quorum, then question 26 should be answered No.

You can download a clean copy of the report (F-040 – Site Status Report) from the “FORMS” tab at the top of this page.

No, a faxed (or mailed) copy is sufficient.

No. The Site Status report would not be considered valid.

Quorum requires that all sites submit a valid Site Status Report 45 calendar days prior to expiration. Failure to do so will result in overdue notifications. It is left to your discretion if you wish to hold your Site Status Report at your site until your scheduled closeout visit to avoid going through Periodic Site Review. 

If you choose to do so, please bear in mind the following:

• Closing visits are often cancelled or rescheduled. It is a good idea to prepare for Periodic Site Review in case this happens by completing your report and notifying Quorum of the situation.
• If we do not receive the report by the due date, we must adhere to our notification procedures that include a fax and expiration warning letter that is copied to your sponsor. Even if you contact us to let us know that you are planning on closing, you will still receive our overdue notifications as part of our due diligence to assure that no sites expire.
• If the report is not received within 14 calendar days of the expiration date, your site will be scheduled for IRB review. Upon review, the IRB may consider your failure to comply with the requirement to submit a Site Status Report as an instance of noncompliance. Please note that findings of noncompliance are reported to the sponsor and the FDA.

No. Once Quorum receives a Site Status Report, a process of analysis and scheduling for the board is started. It is left to your discretion if you wish to hold your report at your site until your scheduled closeout visit to avoid going through Periodic Site Review. Please see the previous question and answer (above) for ramifications of this choice.

Any FDA audit documentation, letters of explanation as required by the form, and any additional information that you think will help Quorum with the review of your site. Please refer to the Periodic Site Review Checklist/Instruction Sheet for further guidance.

An incomplete or inaccurate form, any missing attachment(s), (e.g. FDA audit documentation, letter(s) of explanation, SAEs, PDs, UPs) and/or missing/blank page(s).

Acknowledgement will come in the form of your Notice of Re-Approval documents or closing acknowledgment letter. If you wish to verify sooner whether or not we have received your Site Status Report, you can contact our Site Support Team at (206) 448-4082.

The final rule was published on Tuesday, January 4, 2011.  The effective date is March 7, 2011 and the compliance date is one year from that date: March 7, 2012.  Quorum updated its related procedures by the effective date, March 7, 2011.

The final rule revises the current informed consent regulations to require a new element for informed consent documents and processes that will inform potential participants that information about the research has been, or will be, entered into a databank that is publicly accessible at http://www.ClinicalTrials.gov.  The statement is as follows:

 “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

 The citation for the new regulation is: 21 CFR 50.25(c).

This requirement only applies to studies that are required to be listed on the website http://www.ClinicalTrials.gov. The sponsor will make the determination as to whether a particular research study must be listed on the website.

No, the new statement will only be applied to consent forms for studies that must be listed on the website http://www.ClinicalTrials.gov.  The statement will be included verbatim in new consent forms that are developed after Quorum’s procedures changed by March 7, 2011.  Older consent forms can be revised to include this statement verbatim if the sponsor would like to revise them, but Quorum will not proactively revise existing consent forms as this is not required.

Quorum Review IRB conducts review in accordance with pertinent authorities, including but not limited to, the ICH Guidelines for Good Clinical Practice, U.S. Food and Drug Administration (21 CFR Parts 50 and 56), U.S. Department of Health and Human Services (45 CFR Part 46), the ethical principles outlined in the Belmont Report, the Canadian Food and Drug Regulations (Part C, Division 5), Part 4 of the Canadian Natural Health Products Regulations, and the Tri-Council Policy Statement (TCPS 2).

Quorum Review IRB is registered with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) with registration number IRB 00003226. Quorum Review IRB is also fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Verification of AAHRPP accreditation can be obtained on the AAHRPP website located at http://www.aahrpp.org/www.aspx.

As a research ethics board, Quorum Review IRB is appropriately constituted, organized, and operated in accordance with regulations and guidelines referenced above and the World Medical Association Declaration of Helsinki, to the extent they apply. Quorum Review IRB also complies with other national, state, provincial, and local laws such as the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA Privacy Rule”), the Personal Information Protection and Electronic Documents Act (PIPEDA), and other relevant authorities in jurisdictions that relate to clinical research in which Quorum Review IRB provides oversight.

Quorum expects investigators to disclose potential conflicts of interest involving research staff or immediate family members (including spouses and dependent children). The financial and non-financial interests of investigators, staff and immediate family members that must be reported to Quorum Review IRB are listed below.  These criteria apply equally regardless of funding or regulatory oversight. For more information about these types of conflicts, please review Quorum’s Investigator Handbook.

1. Financial arrangement based on outcome of the study
2. Significant Payment (exclusive of the costs of conducting research)
3. Intellectual property rights or proprietary interests
4. Any significant equity interest in the sponsor of the study
5. Employment or executive relationship with the sponsor
6. Enrollment or recruitment bonuses or finder’s fees
7. Other financial or non-financial relationship that may create an actual or apparent conflict of interest

Investigators are required to complete Quorum’s Conflict of Interest Statement: Disclosure of Financial Interests and Management Plan if any of the above-described conflicts of interest exist.

Possible actions the investigator can take to manage potential conflicts of interest include:

• Disclose the conflict in the consent form
• Complete additional training or education requirements for the investigator and study staff.
• Require a non-conflicted sub-investigator, monitor, or other study staff member to assist or conduct certain parts of the research such as the informed consent process
• Require a designee without a conflict to collect and report study data
• Modify the recruitment and retention plans to account for the existing conflict
• Divest financial interests either partially or completely

All changes to the conflict of interest status of an investigator, a member of the research staff, or an immediate family member that exceeds one of the thresholds listed (or further exceed a threshold already reported to the Board) must be submitted to Quorum Review IRB in a revised Conflict of Interest Statement: Disclosure of Financial Interests and Management Plan.

Quorum understands that organizations have differing policies with respect to conflict of interest. Investigators can report conflicts of interest that do not meet Quorum’s threshold for reporting using the Conflict of Interest Statement and selecting category 7, “Other financial or non-financial relationship.”

The updated PHS regulations, effective August 24, 2012, impose requirements on institutions that receive that receive NIH funding from a grant or cooperative agreement and also investigators involved in such research. Quorum does not receive such funds. Therefore, Quorum’s reporting requirements related to conflict of interest may differ from the investigator’s obligations to report to their institution. If an investigator is required to report under their Institutional policy to the IRB, they may do so using Quorum’s Conflict of Interest Statement and selecting Category 7, “Other financial or non-financial relationship.”

Quorum no longer accepts the FDA Form 3455 from investigators in lieu of the Conflict of Interest Statement. Quorum requires investigators to report other types of conflicts of interest in addition to those that must be reported to the FDA using the FDA Form 3455. However, the first four categories on Quorum’s Conflict of Interest Statement match the questions of the FDA Form 3455, so this document will be helpful for completing Quorum’s form.