Sites FAQs

What are the IRB Reporting Procedures for Emergency Use Investigational Devices?

(8 People have viewed this FAQ)

Quorum has procedures in place for review of emergency use of test articles. If a subject is in a life-threatening situation where no standard acceptable treatment is available, and there is not sufficient time to obtain Board approval, please contact our Initial Study Support department. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.  We highly recommend reading this article about  Emergency Use of Investigational Devices, including FDA Notification and IRB requirements.

Does Quorum have any recommendations regarding the protocol or consent form?

(67 People have viewed this FAQ)

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.

Does Quorum require a CV for each sub investigator?

(60 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.

Does Quorum review research that will be conducted at Canadian sites

(53 People have viewed this FAQ)

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.

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

(51 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.

How does Quorum define a single site vs. a central study?

(51 People have viewed this FAQ)

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.

What are single sites expected to submit to Quorum?

(43 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 are the IRB Submission Requirements for Compassionate Use Investigational Devices?

(4 People have viewed this FAQ)

For Quorum, a proposed compassionate use of an Investigational Device should be submitted as a single site study. We will need the following documents: The protocol should include the information that was previously included in the Investigational Device Exemption (IDE) supplement, specifically:
  1. A description of the patient's condition and the circumstances necessitating treatment;
  2. A discussion of why alternatives therapies are unsatisfactory and why the probable risk of using the investigational device is no greater than the probable risk from the disease or condition;
  3. An identification of any deviations in the approved clinical protocol that may be needed in order to treat the patient; and
  4. The patient protection measures listed above that will be followed.
  5. A monitoring schedule, which should include the investigational nature of the device and the specific needs of the patient. The patient should be monitored to detect any possible problems arising from the device.
For Quorum’s purposes, the submitted consent form may be based off of the consent form for the approved clinical trial. Please contact our Initial Study Support department for more information on submission requirements or access to our Regulatory Attorney Team. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.  

What is the difference between compensation and reimbursement?

(39 People have viewed this FAQ)

“Compensation” refers to payment for participation in a research study.  “Reimbursement” includes reimbursement for parking and travel, the provision of gifts for participant retention purposes, or the provision of medical devices to be retained by the participant following the study, etc.”

For more information see the Quorum Review IRB Handbook (requires an OnQ Portal account).

What are single sites expected to submit to Quorum?

(33 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 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.

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

(32 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.

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

(28 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.

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

(24 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.

Will Quorum review my study if I am listed on the IND?

(22 People have viewed this FAQ)

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.

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

(21 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.

I developed a protocol and received funding to conduct it from a federal agency. Is the federal agency considered the sponsor of the research?

(21 People have viewed this FAQ)

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

What are single sites expected to submit to Quorum?

(20 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 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.

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

(19 People have 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?

(18 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.

Are there any extra steps during the submission process for Principal Investigator Generated Studies?

(18 People have viewed this FAQ)

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.

How is safety information acknowledged for a single site study?

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

(16 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 are the consequences of submitting as a single site study?

(16 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?

(16 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 is safety information acknowledged for a Principal Investigator Generated Study?

(16 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.

What are investigators expected to submit to Quorum for Principal Investigator Generated Studies?

(16 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. 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.

How is safety information acknowledged for a single site Study?

(15 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.

What is Investigator Generated research?

(15 People have viewed this FAQ)

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.

What submission documents are required by Quorum?

(140 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 IRB Submission Requirements for Treatment Use Investigational Devices?

(11 People have viewed this FAQ)

For Quorum, a treatment use investigational medical device protocol is either submitted as a central study (if submitted by the sponsor) or as a single site study (if submitted by the investigator). The submission forms will depend on the type of submission. Please contact our Initial Study Support department for more information on submission requirements or access to our Regulatory Attorney Team. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.

Do you require 1572’s?

(101 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.

What are the IRB Reporting Procedures for Emergency Use Investigational Devices?

(8 People have viewed this FAQ)

Quorum has procedures in place for review of emergency use of test articles. If a subject is in a life-threatening situation where no standard acceptable treatment is available, and there is not sufficient time to obtain Board approval, please contact our Initial Study Support department. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.  We highly recommend reading this article about  Emergency Use of Investigational Devices, including FDA Notification and IRB requirements.

Does Quorum have any recommendations regarding the protocol or consent form?

(67 People have viewed this FAQ)

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.

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

(4 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.

What is the difference between compensation and reimbursement?

(39 People have viewed this FAQ)

“Compensation” refers to payment for participation in a research study.  “Reimbursement” includes reimbursement for parking and travel, the provision of gifts for participant retention purposes, or the provision of medical devices to be retained by the participant following the study, etc.”

For more information see the Quorum Review IRB Handbook (requires an OnQ Portal account).

Will Quorum review my study if I am listed on the IND?

(22 People have viewed this FAQ)

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.

I developed a protocol and received funding to conduct it from a federal agency. Is the federal agency considered the sponsor of the research?

(21 People have viewed this FAQ)

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

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

(18 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.

Are there any extra steps during the submission process for Principal Investigator Generated Studies?

(18 People have viewed this FAQ)

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.

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

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

(16 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 are investigators expected to submit to Quorum for Principal Investigator Generated Studies?

(16 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. 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.

What is Investigator Generated research?

(15 People have viewed this FAQ)

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.

What are the IRB Submission Requirements for Treatment Use Investigational Devices?

(11 People have viewed this FAQ)

For Quorum, a treatment use investigational medical device protocol is either submitted as a central study (if submitted by the sponsor) or as a single site study (if submitted by the investigator). The submission forms will depend on the type of submission. Please contact our Initial Study Support department for more information on submission requirements or access to our Regulatory Attorney Team. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.

Do you require 1572’s?

(101 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.

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

(9 People have viewed this FAQ)

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.

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

(7 People have viewed this FAQ)

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

Do I need to use a submission cover sheet when submitting my recruitment or participant study material?

(6 People have viewed this FAQ)

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.

How does Quorum review radio and TV scripts?

(4 People have viewed this FAQ)

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.

What is the difference between compensation and reimbursement?

(39 People have viewed this FAQ)

“Compensation” refers to payment for participation in a research study.  “Reimbursement” includes reimbursement for parking and travel, the provision of gifts for participant retention purposes, or the provision of medical devices to be retained by the participant following the study, etc.”

For more information see the Quorum Review IRB Handbook (requires an OnQ Portal account).

How should I submit Recruitment or Participant Study Material to Quorum Review IRB?

(3 People have viewed this FAQ)

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.

How do I get/communicate sponsor approval for my recruitment or participant study material?

(3 People have viewed this FAQ)

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.

What does “Replacement Material” mean on my recruitment and participant study material approval document?

(3 People have viewed this FAQ)

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.

Does a posting on ClinTrials.gov need review?

(15 People have viewed this FAQ)

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.

I would like my materials translated, what should I do?

(13 People have viewed this FAQ)

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.

What does Quorum consider to be recruitment materials or participant study materials?

(13 People have viewed this FAQ)

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

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

(11 People have viewed this FAQ)

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

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

(11 People have viewed this FAQ)

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.

What is Generic Material Review?

(11 People have viewed this FAQ)

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.

Do I need to submit participant gifts for review?

(11 People have viewed this FAQ)

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

What does Quorum consider to be protocol study tools?

(11 People have viewed this FAQ)

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.

I have questions about HIPAA and recruitment where can I find those answers?

(10 People have viewed this FAQ)

Please visit the FAQs for HIPAA under "Additional Services."

When does Quorum consider a site to be closed?

(21 People have viewed this FAQ)

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.

What if no participants have been enrolled in this study? How do I complete the Information and Consent Form section?

(2 People have viewed this FAQ)

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.

Do I need to submit Adverse Events, Minor Protocol Deviations or Minor Unanticipated Problems to Quorum Review?

(17 People have viewed this FAQ)

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.

What is a “major” protocol deviation?

(93 People have viewed this FAQ)

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

What is a “minor” protocol deviation?

(83 People have viewed this FAQ)

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.

Who should submit changes to Investigator Brochures, Package Inserts, or Device Manuals?

(5 People have viewed this FAQ)

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

How do I change my Safety Information acknowledgment preference?

(5 People have viewed this FAQ)

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.

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

(42 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.

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

(4 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.

When should sites report a protocol deviation to Quorum?

(38 People have viewed this FAQ)

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.

Do sites need to submit reports of adverse events, minor protocol deviations or other minor problems to Quorum Review?

(29 People have viewed this FAQ)

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.

When should sites report serious adverse events to Quorum?

(27 People have viewed this FAQ)

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.

What are some examples of potential Unanticipated Problems?

(22 People have viewed this FAQ)

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

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

(18 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.

How is safety information acknowledged for a single site study?

(17 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.

Do I need to submit Adverse Events, Minor Protocol Deviations or Minor Unanticipated Problems to Quorum Review?

(17 People have viewed this FAQ)

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.

What is a standard acknowledgment?

(15 People have viewed this FAQ)

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.

Do I need to submit all IND Safety Reports for this study to Quorum?

(15 People have viewed this FAQ)

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.

What should I do if I have several different IND Safety Reports to submit at one time?

(11 People have viewed this FAQ)

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.

What are my options for safety information acknowledgment?

(11 People have viewed this FAQ)

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).

Do I need to report to Quorum any changes regarding sub investigators?

(45 People have viewed this FAQ)

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.
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