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Study Start-Up Process
Welcome to the Quorum study start-up process. We are committed to working with you to make the submission process as straightforward as possible. If Quorum has been identified as the central review board for your study, the sponsor or CRO will submit the protocol, model consent form, and drug/device information on your behalf. You are responsible for submitting only those materials that pertain to the conduct of the study at your research site. To guide you through the submission process, Quorum has developed a checklist of required submission elements. To ensure prompt review of your submission, please review the checklist carefully and complete all submission forms according to the instructions provided. All submission forms must be completed thoroughly before they will be submitted to the Board for review.
If the sponsor has not identified a central Board for your study, you may apply for review as a "single site." In addition to Quorum's standard submission forms, single site investigators are also required to submit those items routinely provided by the sponsor or CRO. Quorum's submission checklist contains a complete list of additional materials to be provided by a single site investigator.
Quorum requires all sites to submit the following documents in addition to the materials already submitted by the sponsor or CRO:
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,
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.
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 assent forms. These can be provided
upon request.
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 the Board meeting at which they will be discussed. Quorum’s review boards meet every Tuesday, Wednesday and Friday, excluding holidays. Research that includes research in Canada will be reviewed at Wednesday’s 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 and holidays for the current calendar year and the submission deadline for each. Please contact us if you need assistance or have questions about the submission process.
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