CTTI will release new recommendations that propose a new approach for investigator qualification during a public webinar on Thurs., Nov. 15. This approach goes beyond repetitive one-size-fits-all training and includes individual experience and protocol-specific preparation.
Current regulations from the U.S. Food and Drug Administration (FDA) require that sponsors and their delegates select qualified investigators. Good Clinical Practice (GCP) training is widely used as the industry standard for ensuring investigators are qualified, but there is little evidence that completion of GCP training alone sufficiently qualifies investigators and their delegates to conduct quality clinical trials.
To address this challenge, 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 and determine whether a site team is a good fit for a particular protocol. 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.
By implementing CTTI’s recommendations, stakeholders could improve the execution of study protocols and ultimately the overall quality of trials. The recommendations could also help create a culture of collaboration and provide ongoing support through formalized mentorship and knowledge-sharing platforms.
The webinar will begin at noon ET and will be led by by Jimmy Bechtel of the Society for Clinical Research Sites (SCRS), Sabrina Comic-Savic of The Medicines Company, and Kate Haratonik of Genentech—a member of the Roche Group.