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General Forms and GuidelinesQuorum's site guidelines and forms are designed with the investigative site in mind, while providing Quorum with the information we need to protect research study participants. Please don't hesitate to contact Quorum if you have questions or comments regarding our guidelines and/or forms.
Quorum Handbook The most comprehensive source for understanding Quorum's policies and procedures. Customers can contact Quorum to obtain the password required to access portions of the Handbook.
Phone: (206) 448-4082 
Initial Submission
Thank you for choosing Quorum for this study. We are committed to working with you to make the initial submission process as straightforward as possible. This page contains all of the forms and materials you will need to prepare your submission for review. Please note the different requirements for "central" vs. "single site" studies below. If you are submitting an investigator-generated protocol please contact us for guidance on additional requirements. Some of the above documents apply to investigational new drug studies (IND studies) only. Certain types of studies, such as investigator-generated or post-marketing studies, may require additional or slightly modified submission documents. Please contact us if you have questions about the submission documents required for your study. To allow adequate time for preparation and review, Quorum requires that all submission materials are received at least one week in advance of a scheduled Tuesday, Wednesday, or Friday IRB/REB meeting. Quorum will assess sites on a daily basis and some sites will receive a decision on an accelerated schedule. The Board Meeting Schedule lists all scheduled meetings for the current calendar year and the submission deadlines for each. Please contact us if you need assistance or have questions about the submission process. Central Study For multi-center ("central") studies, an approved model consent form is developed in cooperation with the sponsor or CRO. Sites are not required to submit a consent form if they intend to use the model consent form. However, sites may request changes to the content of an approved model consent form (considered "unique changes"). Unique changes may include the addition of a Witness Statement, language added/modified to fulfill state law requirements that the model does not already include, or other wording changes. 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. Single Site For single site studies, you will be asked to submit both a hard copy and an electronic copy of the proposed consent form. Quorum has developed a sample consent form which investigators are encouraged to use for guidance in developing single site consent forms. Quorum also has developed sample genetics consent forms and age appropriate consent forms. These can be provided upon request.
Participant Recruitment and Participant Study Materials
Board review and 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. IRB/REB 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 and Participant Study Materials" for guidance on submitting advertisement and recruitment materials for board review. The Guide includes requirements for submission, helpful hints for a successful submission, and a list of materials Quorum does not review. Or, refer to the Quorum Handbook to learn more.
Informed Consent
Refer to Quorum's "Guide to Informed Consent" or the Quorum Handbook for more information on general guidance and Quorum's specific policies regarding informed consent.
Site Changes
When an administrative change occurs at your site, access the "Guide to Site Modifications" for guidance on submitting a change to Quorum. Or, refer to the Quorum Handbook to learn more.
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, turn to our guidelines or the appropriate form. Or, refer to the Quorum Handbook to learn more
Periodic Site Review (formerly Site Continuing Review)
At the time of initial review, the IRB/REB establishes a continuing review period for all approved studies. Continuing review is required at least once per year, although the Board may require it more frequently. The Board will assign each site an anniversary date for an investigator's approval. This date will be noted on the site’s Notice of Approval document. Periodic Site Review must be complete before the anniversary date or IRB approval for the site will expire. Quorum will send a Site Status Report to each site approximately 10 weeks prior to the site anniversary date. The completed Site Status Report should be returned to Quorum at least six weeks prior to expiration to allow adequate time for review. Refer to the Quorum Handbook to learn more.
Site Closeout
Quorum requires investigators to provide formal notice of closure in all instances - whether the study was terminated early, cancelled by the sponsor, or completed. Refer to the Quorum Handbook to learn more.
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