Before initiation of a study , the PI and study persons should be trained by whom?
LW: In the US, there is specific training that culminates in a certificate indicating appropriate training for a PI. While most investigators have not completed this level of certified training, it is offered by a number of groups. Ultimately, it is the sponsor’s responsibility to access the capabilities of both the site and the investigator. The Sponsor/Monitor usually addresses details of study activities during the pre-study initiation meeting. Dr. Pierce has also addressed this question in his responses. CHP: The PI is responsible for the training of all of her/his study staff. The PI usually gets her/his training working in clinical studies under a competent and knowledgeable PI. The apprentice system is what this is called.
