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IRB
Requirements
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IRB Submissions (application, consent forms, supporting documents)
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IRB Approval Letters
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Continuing Review(s)
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Amendments
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Adverse Events
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Violations/Deviations
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Reporting Forms (DSMB reports, Investigator drug/device brochure updates)
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Close out Information
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Investigator response(s) to IRB notification (if applicable)
IRB Decisions
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Approval letters and/or notification of IRB decisions
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Approved recruitment materials
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Approved educational materials/additional study information distributed to subjects (e.g. subject diary)
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Info regarding Federalwide Assurance (FWA); IRB registration and IRB membership (3/2011)
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Letter to Sponsors
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Any additional correspondence relating to the study (e.g. e-mails)
Tips/ Additional Information
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Copies of all signed and dated IRB submissions and correspondences between the study site and IRB should be kept on file.
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The QIU recommends filing documents in reverse chronological order to ensure that documentation provides an accurate history/timeline of study activity from approval to completion. Only one copy of each correspondence is needed.
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Request a copy of any missing documents from your protocol administrator or print them fto include in the binder.
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If documents are filed electronically, write a signed and dated note to file indicating the location.
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If signed and dated correspondences cannot be maintained electronically (e.g. pdf version), keep a hard copy on file.
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Regulations/Guidelines-45 CFR 46
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21 CFR 50
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21 CFR 56
Regulations/ Guidelines
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45 CFR 46
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21 CFR 50
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21 CFR 56
