FAQs

My institution’s IRB has jurisdiction over my site. Can my site be reviewed by Quorum?

(4 People have viewed this FAQ)

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.

I am interested in choosing Quorum as my IRB but my institution still wants to be aware of what is happening with my study. Is this possible?

(3 People have viewed this FAQ)

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.

My study is Federally Funded. Does Quorum review Federally Funded Research?

(2 People have viewed this FAQ)

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.

My study is Federally Funded. Does Quorum review Federally Funded Research?

(2 People have viewed this FAQ)

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.

What is Quorum Review’s Federal Wide Assurance (FWA) number?

(2 People have viewed this FAQ)

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.

I am only allowed to use an Accredited IRB. Is Quorum accredited?

(1 Person has viewed this FAQ)

Yes, Quorum is AAHRPP Accredited.

Do Quorum’s consent forms comply with Canadian provincial requirements?

(2 People have viewed this FAQ)

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.

Will all my Board correspondence post to the OnQ Portal?

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).

What is an informed consent form?

(4 People have viewed this FAQ)

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.

Under what regulatory authorities does Quorum operate?

(4 People have viewed this FAQ)

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.

Is it safe to participate in a clinical research study?

(3 People have viewed this FAQ)

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.

What questions should I ask the clinical investigator or the study staff member before deciding to participate?

(3 People have viewed this FAQ)

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.

How do I know if this research study is right for me?

(3 People have viewed this FAQ)

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.

What are my rights as a research participant?

(3 People have viewed this FAQ)

  • 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

What is an institutional review board (IRB)?

(10 People have viewed this FAQ)

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.

Do you require 1572’s?

(6 People have viewed this FAQ)

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

Does Quorum require a CV for each sub investigator?

(4 People have viewed this FAQ)

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.

How do I submit safety information and unanticipated problems (e.g. Major Protocol Deviations/Violations, SAEs, IND safety reports) to Quorum?

(3 People have viewed this FAQ)

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.

I am interested in transferring jurisdiction of my site from another IRB to Quorum, what should I do?

(3 People have viewed this FAQ)

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.

What differences can I expect when submitting as a single study?

(3 People have viewed this FAQ)

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.

How is safety information acknowledged for a single site study?

(3 People have viewed this FAQ)

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.

I have two facilities, one that is administrative and one that sees patients. Which location should I use for which form?

(3 People have viewed this FAQ)

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.

What are single sites expected to submit to Quorum?

(2 People have viewed this FAQ)

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 Single Site Studies page. 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.

What submission documents are required by Quorum?

(2 People have viewed this FAQ)

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

What are the most common errors Quorum sees on site submissions?

(2 People have viewed this FAQ)

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.

When do I need to complete an Additional Facility Site Information Questionnaire (AFSIQ)?

(2 People have viewed this FAQ)

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.

How is safety information acknowledged for a Principal Investigator Generated Study?

(2 People have viewed this FAQ)

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.

How should I submit safety information and potential unanticipated problems to Quorum Review IRB?

(2 People have viewed this FAQ)

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.

Can I make changes to the size of my approved material?

(1 Person has viewed this FAQ)

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

What type of information is required on an investigator’s CV?

(1 Person has viewed this FAQ)

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.

I am interested in transferring jurisdiction of my site from another IRB to Quorum, what should I do?

(1 Person has viewed this FAQ)

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.

What are the consequences of submitting as a single site study?

(1 Person has viewed this FAQ)

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.

We made modifications to my previously approved material, do I need to submit for review again?

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.

Do I need to submit participant gifts for review?

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

Do you require 1572’s?

(6 People have viewed this FAQ)

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

I received a Site Status Report with the packet for Protocol Continuing Review. Do I need to complete the Site Status Report?

(6 People have viewed this FAQ)

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.

Does the sponsor or sponsor representative need to send Site Status Reports to the investigators to complete?

(4 People have viewed this FAQ)

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.

How do I submit safety information and unanticipated problems (e.g. Major Protocol Deviations/Violations, SAEs, IND safety reports) to Quorum?

(3 People have viewed this FAQ)

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.

I am interested in transferring jurisdiction of my site from another IRB to Quorum, what should I do?

(3 People have viewed this FAQ)

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.

What differences can I expect when submitting as a single study?

(3 People have viewed this FAQ)

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.

How is safety information acknowledged for a single site study?

(3 People have viewed this FAQ)

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.

Where can I find the Board Roster?

(3 People have viewed this FAQ)

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.

What are single sites expected to submit to Quorum?

(2 People have viewed this FAQ)

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 Single Site Studies page. 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.

Where can I obtain an electronic copy of my Continuing Review Report for Protocols?

(2 People have viewed this FAQ)

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

How is safety information acknowledged for a Principal Investigator Generated Study?

(2 People have viewed this FAQ)

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.

How do I obtain help completing the Continuing Review Report for Protocols?

(2 People have viewed this FAQ)

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.

How should I submit safety information and potential unanticipated problems to Quorum Review IRB?

(2 People have viewed this FAQ)

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.

What do I need to include if I want to submit an amendment?

(1 Person has viewed this FAQ)

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.

I am interested in transferring jurisdiction of my site from another IRB to Quorum, what should I do?

(1 Person has viewed this FAQ)

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.

What are the consequences of submitting as a single site study?

(1 Person has viewed this FAQ)

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.

Do Sponsors receive a copy of approved model recruitment and participant study material?

(1 Person has viewed this FAQ)

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.

Do I need to submit participant gifts for review?

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

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