GCP: A Question & Answer Reference Guide Common Clinical Investigator Inspectional Observations * * * * * * * Failure to follow the investigational plan; protocol deviations Failure to comply with Form FDA 1572 requirements Inadequate and/or inaccurate case history records; inadequate study records Inadequate accountability for the investigational product Inadequate subject protection; informed consent issues Safety reporting; failure to report and/or record adverse events Failure to comply with 21 CFR part 56 (IRB) requirements Institutional Review Board Inspection Classifications - Domestic (FY 2019) n=140 Includes 2 RDRC (VAI) 20% (n=28) 1% (n=1) 79% (n=111) NAI NAI: No Action Indicated OAI: Official Action Indicated VAI: Voluntary Action Indicated RDRC: Radioactive Drug Research Committee 710 VAI OAI