Protocol and Amendment Training Audits
Per Good Clinical Practice (GCP) Guidelines, “The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial . . .” (ICH GCP E6(R1) 4.1.1). To document appropriate training on the research protocol of all investigators involved in the study implementation, the CCR instituted two SOPs:
- PM-5: Research Protocol Training Requirements
- PM-9: Research Team Amendment Training
The Office of Education and Compliance (OEC) conducts audits of regulatory files to determine if appropriate documentation of training is available for review.
Protocol and Amendment Training Audit Summaries
2023: Amendment Training SOP Audit
2021: Amendment Training SOP Audit