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Full CommitteesExpedited Review CommitteeThe Expedited Review Committee meets twice every week (Tuesday morning for modifications and progress reports and Tuesday afternoon for new studies and progress reports). The Expedited Review Committee consists of an IRB Specialist and at least one Full Committee Chair or Vice-chair (on a rotating basis). During each 3-4 hour meeting, between 40 and 50 items are reviewed. The deadline for a Tuesday meeting is noon on the previous Thursday. You can usually expect minute excerpts from the Tuesday meetings on Thursday of that week. Serious Adverse Events CommitteeThe Serious Adverse Event Committee (SAE) meets every Wednesday afternoon. This Committee consists of the chairs and vice-chairs of the four Full Committees (on a rotating basis), pharmacy representatives, community members, and representatives from the IRB office. Each week over 300 SAE’s, deviations, and other items (such as IND safety reports) are reviewed. The agenda for each meeting is set two weeks prior to the meeting. You can expect the minute excerpts and consent forms to be released within 2-3 days of the meeting. IRB Executive CommitteeThe Executive Committee of the IRB generally meets once every week and is comprised of the Full Committee Chairs, Vice Chairs, Legal Staff, and the Administrative Staff of the IRB. This Committee is responsible for investigating and adjudicating issues of investigator non-compliance; developing, clarifying, and refining IRB policies; and handling referrals from and making recommendations to other IRB Committees. |
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