Sponsor/CROs FAQs

What is Quorum’s closing criteria for a site?

(35 People have viewed this FAQ)

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".

How do I close my study?

(31 People have viewed this FAQ)

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.

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

(25 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.

If a site is closed, but is being non-responsive, what should I do?

(23 People have viewed this FAQ)

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.

Do I have to get sites that never had study drug delivered/never enrolled participants to complete a closing report?

(23 People have viewed this FAQ)

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.

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

(18 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.

I submitted my Continuing Review Report for Protocols before the report due date. When will it be reviewed?

(16 People have viewed this FAQ)

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.

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

(15 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 the Continuing Review Report for Protocols?

(15 People have viewed this FAQ)

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.

My Protocol Continuing Report due date has passed, but I plan to close the study prior to the expiration date. How do I close as many people as possible and save money while still being compliant?

(15 People have viewed this FAQ)

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.

Why does Quorum contact me when my expiration date is more than a month from now?

(14 People have viewed this FAQ)

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.

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

(13 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.

What if I cannot complete my Continuing Review Report for Protocols by the listed due date?

(13 People have viewed this FAQ)

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.

Why does Quorum request a Continuing Review Report for Protocols—isn’t this just for my sites to complete?

(12 People have viewed this FAQ)

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.

Why are you sending reports requesting Continuing Review as this study has completed?

(11 People have viewed this FAQ)

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.

What steps does Quorum take to make sure my sites don’t expire?

(11 People have viewed this FAQ)

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.

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

(9 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 review research that will be conducted at Canadian sites

(54 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.

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

(52 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?

(45 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 is the difference between compensation and reimbursement?

(40 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).

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

(4 People have viewed this FAQ)

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.

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 schedule of Board Meetings and what are the submission deadlines?

(36 People have viewed this FAQ)

Quorum Review IRB has four 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.

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.

Can you meet my tight deadline/how can I make sure you meet that tight deadline for study startup?

(29 People have viewed this FAQ)

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.

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.

What happens after my study is assigned a Board Review date?

(23 People have viewed this FAQ)

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.

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

(23 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.

Where can I find the Board Roster?

(21 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 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.

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

(2 People have viewed this FAQ)

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.

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

(2 People have viewed this FAQ)

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.

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.

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 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.

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.

Who should I submit documents to (amendments, safety information, etc.)?

(15 People have viewed this FAQ)

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.

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?

(141 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)
  • Medical License
    • Quorum Review IRB verifies the PI’s medical license for all locations where he/she will be conducting research under Quorum Review’s jurisdiction.
    • If the PI is conducting research in a location which does not provide online license verification (e.g. Puerto Rico, certain Canadian provinces, etc.), submission of the PI’s medical license(s) is required.
    • If you do not know if online license verification is available for the location(s) applicable to the PI’s medical license(s), it is recommended to include a copy of the PI’s medical license(s) with the PI’s site submission.
    • If Quorum Review is unable to verify the PI’s medical license(s), processing of the PI’s site submission will be delayed.

How does the OnQ Portal work?

(14 People have viewed this FAQ)

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.

What happens if the Board makes changes to my protocol or consent form?

(12 People have viewed this FAQ)

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.

Who is my Study Manager and what is their job?

(11 People have viewed this FAQ)

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.

Is there a way for me to check on the status of the sites that have submitted for the study?

(11 People have viewed this FAQ)

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.

Why do I have to track changes I want into the consent form (for negotiations)/how do I do this?

(11 People have viewed this FAQ)

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.

I would like to submit my submission through the web portal but do not have an account?

(11 People have viewed this FAQ)

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

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.

Does Quorum review research in Canada?

(1 Person has viewed this FAQ)

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 and Friday 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.

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.

What is the difference between compensation and reimbursement?

(40 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 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 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.  

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

(23 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.

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

(7 People have 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.

What is a Participant Retention Program?

(7 People have viewed this FAQ)

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.

What is the difference between model, mini-model, and site recruitment and participant study materials?

(6 People have viewed this FAQ)

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.

What is the difference between study tools and participant study material?

(6 People have viewed this FAQ)

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.

Are there any differences in submission requirements when submitting generic recruitments materials versus study specific recruitment materials?

(6 People have viewed this FAQ)

Generic Material Submissions require the Generic Material Submission Form.

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.

What are the various ways that recruitment materials/participant study materials be submitted for review?

(5 People have viewed this FAQ)

  • 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

How can I minimize the cost of my recruitment and participant study material review?

(5 People have viewed this FAQ)

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.

What is the difference between compensation and reimbursement?

(40 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).

Why don’t our sites have stamped approved copies of the Diaries and Questionnaires (protocol study tools) submitted with the initial protocol?

(4 People have viewed this FAQ)

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.

What are the characteristics of generic materials?

(4 People have viewed this FAQ)

  • 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 material is one year. Toward the end of the approval period, Quorum will notify the client that the approval will expire unless the client requests otherwise. If Quorum receives no response from the client before the end of the approval period, Quorum will cancel its approval for the material, and the material must no longer be used.
  • 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

What is a National or Regional Recruitment Campaign?

(4 People have viewed this FAQ)

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.

How does Quorum interact with third party vendors and/or Advertising Agencies?

(3 People have viewed this FAQ)

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.

What if I originally indicated that I wanted sponsor approval on site materials in the central Study Questionnaire but I now wish to change my preference (or vice versa)?

(3 People have viewed this FAQ)

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

What does it mean to request sponsor approval for site recruitment or participant study materials?

(3 People have viewed this FAQ)

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.

What are the defining characteristics of national and regional recruitment materials?

(3 People have viewed this FAQ)

  • 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

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

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.

How should I submit Recruitment material to Quorum Review IRB?

(11 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 your Study Manager for assistance.

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.

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."

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.

Do I need to submit protocol-level safety information?

(8 People have viewed this FAQ)

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.

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.

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 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.

I don’t see formal acknowledgment letters for PD’s and SAE’s in the site documents. Are the site files missing something?

(3 People have viewed this FAQ)

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.

Does Quorum issue approval for Investigator Brochures (IB) and other product information?

(3 People have viewed this FAQ)

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.

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.

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 safety information should be reported to Quorum?

(12 People have viewed this FAQ)

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.

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).

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 is sponsor acknowledgement?

(1 Person has viewed this FAQ)

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.

A site neglected to obtain IRB approval prior to implementing a protocol waiver. What should the site do now?

(1 Person has viewed this FAQ)

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.

How does a site obtain prospective (prior) permission to implement a protocol waiver?

(1 Person has viewed this FAQ)

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.

What happens when there are changes to study tools?

(8 People have viewed this FAQ)

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.

How do I submit an amendment?

(8 People have viewed this FAQ)

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

How do I request a consent form revision?

(5 People have viewed this FAQ)

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.

How do I locate the most current version of the “Quorum-approved” consent form?

(5 People have viewed this FAQ)

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

We’re revising our protocol, but first we’d like to know what the Board thinks. How do we go about getting this input?

(4 People have viewed this FAQ)

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.

How often are amendments reviewed?

(4 People have viewed this FAQ)

Amendments are reviewed at our Daily Board meeting.

What if my health gets worse while I am participating in the study?

(24 People have viewed this FAQ)

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.

We are adding a sub-study that only some sites will participate in; how should we submit this information?

(2 People have viewed this FAQ)

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.

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

(11 People have 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.

When should I submit a protocol amendment?

(11 People have viewed this FAQ)

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.

How do I notify you if a contact within our company changes?

(11 People have viewed this FAQ)

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.

Do I need to submit administrative changes?

(11 People have viewed this FAQ)

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

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