The FDA has an expectation that the study team has knowledge of the applicable human subject regulations and of investigator responsibilities. The regulations do not specifically state that all staff members need to have GCP and HSP training, however, most institutions have internal GCP and HSP training requirements that must be met prior to conducting human subjects research.
To verify that training expectations are met, you must be aware of your institution’s policy related to training and also that of the sponsor. Before initiating a study, have the study sponsor clearly define sponsor training requirements and review your institution’s policy related to training requirements. Be sure to maintain all training certificates for the duration of the study.
