Working Paper Article Version 1 This version is not peer-reviewed

Improving the Quality Conduct and Efficiency of Clinical Trials with Training: Recommendations for Qualification of Investigators and Delegates

Version 1 : Received: 2 October 2019 / Approved: 8 October 2019 / Online: 8 October 2019 (05:18:34 CEST)

How to cite: Bechtel, J.; Chuck, T.; Forrest, A.; Hildebrand, C.; Panhuis, J.; Pattee, S.R.; Comic-Savic, S.; Swezey, T. Improving the Quality Conduct and Efficiency of Clinical Trials with Training: Recommendations for Qualification of Investigators and Delegates. Preprints 2019, 2019100076 Bechtel, J.; Chuck, T.; Forrest, A.; Hildebrand, C.; Panhuis, J.; Pattee, S.R.; Comic-Savic, S.; Swezey, T. Improving the Quality Conduct and Efficiency of Clinical Trials with Training: Recommendations for Qualification of Investigators and Delegates. Preprints 2019, 2019100076

Abstract

The Clinical Trials Transformation Initiative (CTTI) Investigator Qualification Project addresses the need for a more efficient and effective means of identifying qualified clinical investigators and delegates. Selection of investigators and delegates who are qualified by training and experience to conduct clinical trials is essential to safeguarding protections for study participants and ensuring data quality and integrity. Sponsors generally document investigator qualification through training on the principles of good clinical practice (GCP), as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopted by regulatory authorities in the US, Japan and the European Union. Although these GCP principles provide an important foundation for promoting the conduct of quality clinical trials, the industry standard “one-size-fits-all” GCP training may not fully prepare investigators and delegates for conducting quality clinical trials. Routine GCP training alone may not be sufficient to prepare an inexperienced member of a site team, while repeating such training is unlikely to enhance the qualifications of an experienced researcher. The CTTI project team used findings from qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to identify gaps and redundancies in the current training of investigators and their delegates and recommend practical, action-based solutions. CTTI provides recommendations on how to implement a more efficient and effective means of qualification for investigators and delegates, determine whether a site team is a good fit for a particular protocol, and improve the quality of clinical trial conduct.

Subject Areas

clinical trials; investigator qualification; good clinical practice; investigator training

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