Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant

Version 1 : Received: 17 January 2020 / Approved: 19 January 2020 / Online: 19 January 2020 (04:46:48 CET)

How to cite: Swezey, T.; McGuire, F.H.; Hurley, P.; Panhuis, J.; Goldstein, K.; Chuck, T.; Dombeck, C.; Perry, B.; Brennan, C.; Phrsai, N.; Corneli, A. More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant. Preprints 2020, 2020010209 (doi: 10.20944/preprints202001.0209.v1). Swezey, T.; McGuire, F.H.; Hurley, P.; Panhuis, J.; Goldstein, K.; Chuck, T.; Dombeck, C.; Perry, B.; Brennan, C.; Phrsai, N.; Corneli, A. More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant. Preprints 2020, 2020010209 (doi: 10.20944/preprints202001.0209.v1).

Abstract

Background: Good clinical practice (GCP) training is the industry standard for ensuring the quality conduct of registrational clinical trials. However, concerns have been raised about whether the current structure and delivery of GCP training sufficiently prepares clinical investigators and their delegates to conduct clinical trials. Methods: We conducted qualitative semi-structured interviews with 13 clinical investigators and 10 research sponsors to 1) examine characteristics of the quality conduct of sponsored clinical trials, including critical tasks and concerns perceived as essential for trial quality, 2) identify key knowledge and skills required to perform critical tasks, and 3) identify gaps and redundancies in GCP training and areas of improvement to ensure the quality conduct of clinical trials. We used applied thematic analysis to analyze the data. Results: The top three tasks identified as critical for the quality conduct of clinical trials were obtaining informed consent, ensuring protocol compliance, and protecting participants’ health and safety. Respondents acknowledged that GCP principles address each of these critical tasks; however, they described many challenges and burdens of GCP training, including high training frequency and repetitive content. Respondents suggested moving beyond GCP training as a mere check-box activity by making it more effective, engaging, and interactive. They also emphasized that applying GCP principles in a real-world, skills-based environment would increase the relevance of GCP training to investigators and their delegates. Conclusion: Our findings indicate that although investigators and sponsors recognize that GCP training addresses critical tasks necessary to the quality conduct of clinical trials, they articulated the need for significant improvement in the design, content, and presentation of GCP training.

Subject Areas

good clinical practice; clinical trials; quality; investigator training; clinical investigator

Comments (0)

We encourage comments and feedback from a broad range of readers. See criteria for comments and our diversity statement.

Leave a public comment
Send a private comment to the author(s)
Views 0
Downloads 0
Comments 0
Metrics 0


×
Alerts
Notify me about updates to this article or when a peer-reviewed version is published.
We use cookies on our website to ensure you get the best experience.
Read more about our cookies here.