CTTI released new recommendations proposing a new approach for investigator qualification today during a public webinar. This approach goes beyond repetitive one-size-fits-all training and includes individual experience and protocol-specific preparation.
While Good Clinical Practice (GCP) training is widely used as the industry standard for investigator qualification, there is little evidence that completion of GCP training alone sufficiently qualifies investigators and their delegates to conduct quality clinical trials. In fact, the most common deficiencies noted during investigator inspections are often directly related to GCP principles. Furthermore, redundant GCP training creates an unnecessary burden for site teams and limits the opportunity for more valuable, protocol-specific learning and preparation.
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 in implementing a more efficient and effective means of qualification. 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 can also help stakeholders create a culture of collaboration and provide ongoing support through formalized mentorship and knowledge-sharing platforms.
Recognizing that successful clinical trials require not only qualified site teams but also well-designed protocols and robust site-based infrastructure, CTTI encourages site teams to use these new recommendations in conjunction with its Quality by Design recommendations on protocol development and Investigator Community recommendations for a holistic approach to conducting quality clinical trials.