During a public webinar on Thurs., Nov. 15, CTTI released new recommendations that propose a fresh approach for investigator qualification. The webinar, now available online, explored how these new recommendations can move qualification activities beyond repetitive one-size-fits-all training to include individual experience and protocol-specific preparation.
While current FDA regulations state that sponsors and their delegates are responsible for selecting qualified investigators, no guidelines exist for how to meet this requirement. Good Clinical Practice (GCP) training is widely used as the industry standard, but there is little evidence that it sufficiently qualifies investigators and their delegates to conduct quality clinical trials.
CTTI convened a team of experts and leaders across the clinical trials enterprise to develop new recommendations and resources that can help to implement a more efficient and effective qualification process. CTTI’s recommended approach recognizes previous training and experience, identifies gaps in knowledge and skills, and improves understanding of how to apply GCP principles to the conduct of clinical trials.
“If we are to support successful clinical trial conduct, we can’t look at training in isolation,” said Sabrina Comic-Savic of The Medicines Company, who presented during the webinar. “These recommendations come as part of an overall approach that CTTI is taking to improve the whole ecosystem where sites operate in order to support the quality conduct of clinical trials.”
The webinar also featured Jimmy Bechtel of the Society for Clinical Research Sites (SCRS) and Kate Haratonik of Genentech—a member of the Roche Group.