Protocol Registration Manual (version 3.0, April 2015) Essential Documents Appendix (version 2.0, 20/Dec/2006)

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Presentation transcript:

Protocol Registration Manual (version 3.0, April 2015) Essential Documents Appendix (version 2.0, 20/Dec/2006)

Critical finding CSMG PWI 2.0: Critical finding are defined, In general, as serious breaches of DAIDS policies and procedures either in the conduct of the clinical trial ,the accountability of investigational product or Implementation of regulatory requirements Persistent non-compliance with GCP Overall trend that may represent inattention to protocol requirements on the part of study staff