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Please describe the regulatory authorities under which Quorum operates. |
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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).
Quorum Review IRB is registered with the United States 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. |
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I would like to submit my research site to Quorum. How do I start? |
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Please see the Study Start-Up Process section
of the site for forms and information about getting started. To ensure that the
review process goes smoothly, please coordinate your submission with the
sponsor for the study. Feel free to contact
us with any questions about the submission process. |
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How often does the Board meet? |
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Quorum holds meetings of the institutional review board/review ethics board on Tuesday, Wednesday, and Friday of each week, excluding major holidays (see the Quorum Review Board Schedule for exact dates). On Wednesday is our North American meeting, at which Quorum’s IRB/REB reviews research that will include Canadian sites. |
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When will the material I submitted be reviewed? |
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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 meeting on the following Friday. Materials involving Canadian research will be scheduled for the North American meeting on Wednesday.
All required submission elements must be received before an item can be scheduled for IRB/REB review.
Qualifying site submissions will be reviewed on a daily basis. In addition, some items may qualify for Expedited Review. Please contact us for more information about Expedited Review. |
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Does Quorum review research that will be conducted at Canadian sites? |
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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 here. |
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How do I renew approval for a study? |
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Quorum will send notification of pending expiration approximately 75 days before your site's approval is due to expire.
If your site is scheduled to remain active after the last day of your current approval period, you must submit a completed Site Status Report at least 45 days before the expiration date.
If your site is scheduled to close before the last day of your current approval period, you must submit a completed Site Status Report prior to your expiration date.
If a Report is not received by the due date, IRB/REB approval may expire. A Board finding of continuing noncompliance may be reported to the study Sponsor and the FDA. (Please see the Continuing Review and Site Closure FAQ here.)
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How do I submit a change of address or a new facility?
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Quorum does not require the submission of or acknowledge receipt of a revised Form FDA 1572. Instead, Quorum's Site Information Change Request Form is the best way to report to Quorum any changes in your site's address, contact information, study coordinator or participant compensation. Quorum’s Primary Facility Change Form and Principal Investigator Change Form allow you to submit major changes. Please take a look at our Instructions for Submitting Study Site Modifications to Quorum Review for guidance on the use of the change forms and any additional requirements for documentation. Contact Quorum's Site Support Team for assistance at 1-877-IRB-9883 or sitesupport@quorumreview.com.
The Board will review the information you submit and, if appropriate, issue a new consent form.
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How do I submit safety information and unanticipated problems (e.g. Major Protocol Deviations/Violations, SAEs, IND
safety reports) to Quorum? |
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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, please see our
Reporting Safety Information and Unanticipated Problems guidance document. This document is also provided
with your initial Notice of Approval, and subsequent Notice(s) of Re-Approval.
Please do not hesitate to contact us with any
questions.
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How do I submit recruitment material to Quorum? |
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All material intended for use in the recruitment of potential study
participants must be reviewed and approved by the Board prior to use. These
materials include, but are not limited to, advertisements in newspapers,
television, radio, bulletin boards, posters, flyers and Internet
postings.
For detailed guidance on submitting recruitment material to Quorum,
please see our Guide to Recruitment and Participant Study Materials.
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How do I make changes to the content of my Board-approved consent form? |
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Changes to the content of a consent form, outside of site specific contact information, that are not submitted by the sponsor
are considered "unique changes." Unique changes may include the addition of a
Witness Statement, language added/modified to fulfill state law requirements,
or other changes to the wording of the consent form.
All unique consent form changes must be tracked into an electronic copy of the
current Board-approved version of the consent form and submitted electronically.
For central studies, requests for unique consent form changes must be
accompanied by documentation of sponsor approval for the change. Failure to submit unique changes in the appropriate format or with the necessary sponsor authorization will result in delays in review.
Revised consent forms will be reviewed according to regular submission
deadlines (see the Quorum
Review Board Meeting Schedule). Some revised consent forms may qualify
for Expedited Review. Please contact Quorum's Site Support Team at 1-877-IRB-9883 or sitesupport@quorumreview.com for more information.
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How do I request a non-English consent form? |
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Upon request, Quorum will obtain a translated consent form for use in
consenting participants in their first language. All sites who wish to use a
non-English consent form must be specifically approved to do so. To request a
translation, please complete a Site Information Change Request form. Contact Quorum's Site Support Team for assistance at 1-877-IRB-9883 or sitesupport@quorumreview.com with the following
information:
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Language needed (and dialect, if applicable)
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Name of study personnel at your site fluent in this language
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Copy of your policy or procedure for the consent of non-English speaking
participants
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Whom do I contact with questions about an existing study? |
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All questions can be directed to Quorum's Site Support Team at 1-877-IRB-9883 or sitesupport@quorumreview.com.
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