CTTI Offers Recommendations to Streamline GCP

The Clinical Trials Transformation Initiative (CTTI) has announced recommendations to streamline Good Clinical Practice (GCP) training of investigators who participate in clinical trials. GCP is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The CTTIrecommendations were developed by a multi-stakeholder project team that considered the results of a literature review and analysis of some common GCP training programs, as well as discussions with experts on challenges regarding GCP training and possible solutions. The recommendations focus on four components of GCP training: minimum essential elements, training frequency, training format, and evidence of completion. Adaptability is encouraged as appropriate; for example, the frequency of training should be sufficiently flexible to accommodate different experience levels, gaps in training, etc., and should not be the same course every time.     Read the full release here.