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

28. 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