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RCRC holds meetings twice weekly, Monday and Thursday. All submissions are due at 12:00 NOON (CST) on the deadline day. Please see the Meeting Calendar for submission deadlines. All study-related documents and attachments must be received by noon for your submission to be considered complete. If you are unable to meet the deadline, please contact our office as we may be able to accommodate your submission. Submissions may be sent using SafeSync™, our secure online submission system. We also accept submissions through email, fax, or mail. Drug and/or Device Research - Initial Review Submission Forms Non-Drug / Non-Device Research - Initial Review Submission Forms Additional Submission Forms for Initial Review, as Applicable Study Status Reports Federal regulations require IRBs to conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year as determined by the IRB. RCRC requires the following status reports prior to the IRB approval expiration date. Ongoing Review - Single Site Research Investigator participating in Single-Site Research Ongoing Review - Multiple Site Research Multi-Site Research in which RCRC serves as the central IRB Study Closure Modifications to Ongoing Research Unanticipated Problems Unanticipated Problems (Form 300) Safety Reports Due to the FDA Guidance Document on Reporting Adverse Events, effective April 5, 2010, RCRC no longer requires submission of Safety Reports unless they are determined to be an unanticipated problem by the Investigator/Sponsor. Please click here to read RCRC’s policy on unanticipated problems and submission of safety reports required to be reported by the sponsor. Miscellaneous Forms General items, such as generic recruitment materials and in-house clinic rules which do not contain protocol-specific information, do not require IRB approval. However, upon request, RCRC will provide review of these items. Please use the form below to request review for general items. Guidance Documents Additional Resource
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