Time and energy are valuable resources to clinical investigators. CTTI’s recent publication, “Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency,” provides evidence that redundant Good Clinical Practice (GCP) training places an unnecessary burden on investigators. Investigators should be relieved of the burden of repetitive training so they can focus on what matters most: protecting the rights, integrity, and confidentiality of clinical trial participants and assuring the credibility and accuracy of data and reported results. The authors offer suggestions to increase applied learning, focus on relevant trial information, and tailor training for specific job functions.

CTTI’s GCP Training Project team conducted a literature review to inform the project on current practices in the implementation of GCP training and analyzed sample GCP training programs. The findings were discussed by a multi-stakeholder group of experts who helped the team to develop official recommendations that were released in 2015. The recommendations include the 13 minimum essential elements for a training program, training frequency and format, and evidence of successful completion of training.

The paper was published in Therapeutic Innovation & Regulatory Science (TIRS).