Protocol and Modification 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 Training Requirements for IRB Modifications

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 Modification Training Audit Summaries

April:  Research Protocol Training SOP Audit

November:  Amendment Training SOP Audit
June:  Research Protocol Training SOP Audit
February:  Amendment Training SOP Audit

2021:  Amendment Training SOP Audit 

Last updated by Grady, Deborah (NIH/NCI) [E] on Jun 03, 2024