FAQs for Sites
Q. How often does the Board meet? >>
Quorum holds meetings of the institutional review board/review ethics board every day of the 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. 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? >>
Site submission deadlines are 5:00pm Pacific Time, every weekday. Please contact Initial Study Support, Site Support or log in to the OnQ Portal and see Quorum’s IRB/REB Meeting and Review Cycle Timing sheet for more information on timelines.
Q. Does Quorum review research that will be conducted at Canadian sites? >>
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.
Q. How do I renew approval for a study? >>
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.
Q. How do I submit a change of address or a new facility? >>
Quorum does not require the submission of or acknowledge receipt of a revised Form FDA 1572. Instead, Quorum's Change Request Form for Sites is the best way to report to Quorum any changes in your site's address, contact information, study coordinator or participant compensation. Quorum’s Change in Primary Facility 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.
The Board will review the information you submit and, if appropriate, issue a new consent form.
Q. How do I submit safety information and unanticipated problems (e.g. Major Protocol Deviations/Violations, SAEs, IND safety reports) to Quorum? >>
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.
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.
Q. How do I submit recruitment material to Quorum? >>
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.
For detailed guidance on submitting recruitment material to Quorum, please see our Guide to Recruitment and Participant Study Materials.
Q. How do I make changes to the content of my Board-approved consent form? >>
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 rationale and 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.
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 rationale and 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.
Q. How do I request a non-English consent form? >>
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 Change Request Form for Sites. Contact Quorum's Site Support Team for assistance at 1-877-IRB-9883 or sitesupport@quorumreview.com with the following information.
Q. What information should be included in the Consent Form if a Certificate of Confidentiality is Issued? >>
Participants must be informed in the informed consent document regarding the limitations and protections of the Certificate of Confidentiality. Please notify Quorum Review IRB if you have requested or will be requesting a Certificate of Confidentiality. Also note that if a Certificate of Confidentiality is obtained after the study has commenced, the consent form will need to be revised in order to inform subjects about the Certificate, including its limitation and protections.
Please contact Quorum Review IRB if you have questions regarding what type of language needs to be included in the consent form. If Quorum is notified that a Certificate of Confidentiality has been or will be obtained, Quorum can also include standard template language in the consent form.
Please contact Quorum Review IRB if you have questions regarding what type of language needs to be included in the consent form. If Quorum is notified that a Certificate of Confidentiality has been or will be obtained, Quorum can also include standard template language in the consent form.
Q. How do I know if my site is in compliance with local law? >>
Please download our local law document.
Q. Whom do I contact with questions about an existing study? >>
All questions can be directed to Quorum's Site Support Team at 1-877-IRB-9883 or sitesupport@quorumreview.com.
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.