The institutional review board/research ethics board currently meets on Tuesday, Wednesday, Thursday 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.
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.
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.
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.
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 email@example.com.
The Board will review the information you submit and, if appropriate, issue a new consent form.
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.
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.
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 firstname.lastname@example.org for more information.
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 email@example.com with the following information.
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 download our local law document.
All questions can be directed to Quorum’s Site Support Team at 1-877-IRB-9883 or firstname.lastname@example.org.