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Procedure to Ensure Prompt Reporting Of Unanticipated Problems Involving Risks to Subjects or Others to the IRB - IRB PRO106
This procedure delegates responsibilities of the Investigator, OIRB and IRB for ensuring prompt reporting of unanticipated problems encountered in research.
UAB Policy on Reporting to Institutional Officials and Regulatory Agencies- IRB POL024
This policy describes the IRB's obligation to report certain determinations to UAB officials, regulatory and other federal regulatory agencies, and sponsors.
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