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Sponsor Forms and GuidelinesQuorum sponsor forms and guidelines are designed to collect vital study information necessary for the Board to render its decisions. Documents and information in this section pertain to study start-up, maintenance, and protocol continuing review: For information about the review of research in Canada, please see our page about North American Research. Quorum Handbook The most comprehensive source for understanding the policies and procedures that govern Quorum’s institutional review board/research ethics board. Customers can contact Quorum to obtain the password required to access portions of the Handbook.
Phone: (206) 448-4082 
Study Start-Up
Central Study Questionnaire A comprehensive document detailing the specifics of the Protocol such as:
Quorum Device Studies Form Supplemental form for Device Studies only. Please complete and enclose with Protocol submission materials when submitting a Device Study.
Safety Reporting
If a safety event meets Quorum’s reporting requirements, an investigator is required to report the event to Quorum within 10 business days of becoming aware of the event. To determine if an event meets Quorum’s reporting requirements, refer to our guidelines or the appropriate form. Sponsor Reports of Changes to Investigator Brochures, Package Inserts, and Device Manuals
Protocol Level Safety Information and Unanticipated Problems
Quorum allows the sponsor to accept responsibility for submitting study-wide safety information to Quorum on behalf of all investigators involved with the study. The sponsor can make this choice by providing the appropriate information on the Central Study Questionnaire. If the sponsor has assumed this responsibility, the sponsor will submit all protocol-level safety information to Quorum at the same time these documents are sent to investigators. Or, refer to the Quorum Handbook to learn more.
Participant Recruitment
Board approval is required for all recruitment materials that are intended to be seen or heard by prospective participants to solicit their participation in a study. Approval is also required for participant study materials, which are documents provided to participants during the course of the study. Refer to Quorum’s "Guide to Participant Recruitment" for guidance on submitting advertisement and recruitment materials for board review; including requirements for submission, helpful hints for a successful submission, and a list of materials Quorum does not review.
The sponsor may submit model advertising or participant recruitment materials on behalf of all or some of the investigators participating in a protocol. These materials will be approved without investigator-specific contact information, which can be added by the investigator after approval. For model recruitment material, the Board will only review the submitted materials for those investigators that the sponsor specifically identifies. These materials are reviewed within 48 hours of receipt and approval documents will be shipped to investigators within five business days of approval. Or, refer to the Quorum Handbook to learn more.
Continuing Review
When Quorum is acting as a central ethical review board, Quorum will send the sponsor a continuing review packet that will include a copy of the Protocol Continuing Review Report and a copy of the materials provided to sites for continuing review. When Quorum is not the central Board for a multi-site study, Quorum will send the reminder and report form to the investigator who then must forward it on to the sponsor. Sponsors must return the Protocol Continuing Review Report by the due date indicated on the form so that the protocol can be reviewed prior to the sites. Or, refer to the Quorum Handbook to learn more.
Study Changes
Please complete the above form if there are any significant changes that need to be made to any of the sections listed on the Central Study Questionnaire. This will allow for thorough and accurate documentation for both Quorum and the sponsor concerning the specifics of the study. Amendments and Revised Consent Forms Quorum requires review of all changes in research activity, including protocol amendments and/or consent form revisions. Please submit the following information, at minimum:
All consent form revisions must be tracked in electronically using the current, Board-approved version of the consent form. Some protocol amendments may qualify for Expedited Review. Or, refer to the Quorum Handbook to learn more.
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