Frequently Asked Questions by Sponsors
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Q. I would like to submit a study to Quorum. How do I start? >>
Please see the Study Start-Up Process section of the site for forms and information about getting started. Feel free to contact us with any questions.
Q. How often does the Board meet? >>
The institutional review board/research ethics board currently meets on Tuesday, Wednesday and Friday of each week, excluding major holidays (see the Quorum Review Board Meeting Schedule for exact dates) for the initial review of all protocols and consent forms. Quorum also has a daily Board that meets to review amendments and major consent form changes.
Q. When will the material I submitted be reviewed by the Board? >>
Submission deadlines are 5:00pm Pacific Time, each Tuesday, Wednesday and Friday, one week prior to the meeting at which you wish to have your materials reviewed.
For example, all completed material received by Tuesday will be scheduled for the Board meeting on the following Tuesday. All completed material received by Friday will be scheduled for the Board meeting on the following Friday.
Submission deadline for daily meetings is close of business two days prior.
All required submission elements must be received before an item can be scheduled for Board review.
Please note that some items may qualify for Expedited Review. Feel free to contact your Study Manager for more information about Expedited Review.
For example, all completed material received by Tuesday will be scheduled for the Board meeting on the following Tuesday. All completed material received by Friday will be scheduled for the Board meeting on the following Friday.
Submission deadline for daily meetings is close of business two days prior.
All required submission elements must be received before an item can be scheduled for Board review.
Please note that some items may qualify for Expedited Review. Feel free to contact your Study Manager for more information about Expedited Review.
Q. Does Quorum review research in Canada? >>
Yes. Quorum Review IRB maintains an ethics review board (referred to as the “North American” Board) and serves as a duly convened research ethics board (REB) and central institutional review board (IRB). The North American Board complies with applicable regulatory requirements and meets every Wednesday to review U.S. and Canadian studies. Quorum is AAHRPP-accredited and accepts both privately and publically funded research in Canada. Read more about our North American review here, or contact us for more information.
Q. How do I renew IRB approval for a study? How do I renew IRB approval for the investigators involved in a study? >>
Quorum will send notification of pending expiration to the primary study contact approximately 75 days before study approval is due to expire. To renew study approval, please submit a completed Protocol Continuing Review Report at least 60 days prior to the study expiration date.
Quorum will send notification of pending expiration to all active sites under Quorum's jurisdiction approximately 75 days before the site's approval is due to expire. All sites scheduled to remain active after the last day of their current approval period must submit a completed Site Status Report at least 45 days before their expiration date. All sites scheduled to close before the last day of their current approval period must submit a completed Site Status Report prior to their expiration date.
All sites that do not submit a completed report before their expiration date will be scheduled for consideration of suspension and, potentially, termination by the Board. (Please see the Continuing Review and Site Closure FAQ for more information)
Quorum will send notification of pending expiration to all active sites under Quorum's jurisdiction approximately 75 days before the site's approval is due to expire. All sites scheduled to remain active after the last day of their current approval period must submit a completed Site Status Report at least 45 days before their expiration date. All sites scheduled to close before the last day of their current approval period must submit a completed Site Status Report prior to their expiration date.
All sites that do not submit a completed report before their expiration date will be scheduled for consideration of suspension and, potentially, termination by the Board. (Please see the Continuing Review and Site Closure FAQ for more information)
Q. How do I submit a protocol amendment? >>
Quorum requires review of all changes in research activity, including protocol amendments and/or consent form revisions. Quorum offers a cover sheet to assist with submitting an amendment.
Please submit the following required information, at minimum, to your Study Manager:
Please submit the following required information, at minimum, to your Study Manager:
- Cover letter
- Summary of changes
- Rationale for changes
- Full text of amendment or amended protocol
- Tracked, electronic copy of consent form(s), (if applicable)
Q. How do I request a consent form revision? >>
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.
Q. I am preparing a consent form for a new study. What does Quorum look for in a consent form? >>
The Board reviews consent forms for compliance with regulatory requirements and consistency with protocol information, as well as for grammar, formatting, and readability. Please contact us if you would like to receive a sample consent form to review. You also can review our complete set of template consent forms and guidelines in the Quorum Handbook © or the Quorum Web Portal.
Q. How do I know if the sites in my study are in compliance with local laws? >>
Please see our local law document.
Q. How do I request a non-English consent form? >>
Upon request, Quorum will obtain a translated consent form for use in consenting a participant in his/her first language. Each site that wishes to use a non-English consent form must be specifically approved to do so. Please contact your Study Manager to further discuss your translation options.
Q. Whom do I contact with questions about my existing study? >>
All questions can be directed to your Study Manager. We take pride in our single point of contact system that enables you to route all questions through a single individual who is responsible for all aspects of a study. For general questions you can always contact us.
Q. How do I know if this study needs IRB Review? >>
Please see Quorum’s section on Exemption Determinations.
Please describe the regulatory authorities under which Quorum operates.
Quorum Review IRB conducts review in accordance with pertinent authorities, including but not limited to, the ICH Guidelines for Good Clinical Practice, U.S. Food and Drug Administration (21 CFR Parts 50 and 56), U.S. Department of Health and Human Services (45 CFR Part 46), the ethical principles outlined in the Belmont Report, the Canadian Food and Drug Regulations (Part C, Division 5), Part 4 of the Canadian Natural Health Products Regulations, and the Tri-Council Policy Statement (TCPS 2).
Quorum Review IRB is registered with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) with registration number IRB 00003226. Quorum Review IRB is also fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Verification of AAHRPP accreditation can be obtained on the AAHRPP website located at http://www.aahrpp.org/www.aspx.
As a research ethics board, Quorum Review IRB is appropriately constituted, organized, and operated in accordance with regulations and guidelines referenced above and the World Medical Association Declaration of Helsinki, to the extent they apply. Quorum Review IRB also complies with other national, state, provincial, and local laws such as the U.S. Health Insurance Portability and Accountability Act of 1996 ("HIPAA Privacy Rule"), the Personal Information Protection and Electronic Documents Act (PIPEDA), and other relevant authorities in jurisdictions that relate to clinical research in which Quorum Review IRB provides oversight.