GCP: A Question & Answer Reference Guide Common Sponsor/Monitor/CRO Inspectional Observations * Failure to select qualified investigators and/or monitors, ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan. (General responsibilities of sponsors) * Failure to maintain and/or retain adequate records in accordance with 21 CFR 312.57; accountability for the investigational product * Failure to bring non-compliant investigators into compliance Sponsor-Investigator Inspections Classifications - Domestic (FY 2019) n=13 46% (n=6) 54% (n=7) NAI VAI OAI NAI: No Action Indicated OAI: Official Action Indicated VAI: Voluntary Action Indicated Common Sponsor-Investigator Inspectional Observations * * * * * * * * Failure to submit an Investigational New Drug (IND) application Failure to ensure proper monitoring of the clinical investigation Failure to follow the investigational plan 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 Failure to comply with 21 CFR part 56 (IRB) requirements 712