Table 3.

Recommendations for GCP Training From the Clinical Trials Transformation Initiative.

Component	Recommendation
Recommended minimum essential elements for a GCP training program and other aspects of training content	The 13 elements from the investigator section of the ICH E6 Good Clinical Practice Consolidated Guidance. Other training topics may be considered if needed, depending on the nature and scope of proposed research GCP training programs should provide a framework for clinical research conduct. Training programs should emphasize topics that are Outside the scope of medical practice (eg, safety reporting, IRB review, research informed consent) Areas of recurring noncompliance Avoid redundancy of topics covered in protocol-specific training More advanced and role-based GCP training should be considered for those who have completed initial GCP training.
Frequency of training	GCP training is recommended to occur at a minimum of every 3 years. 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. The training should be mutually accepted across organizations so that trainees may qualify for the time period without needing retraining for each new trial or sponsor.
Format of training	There are no specific recommendations on format. An online format may be the most practical to impart GCP training.
Evidence of completion	Satisfactory completion of a training program—such as certificate, test score, or other formal confirmation of training received—should be documented.

Abbreviations: GCP, Good Clinical Practice; ICH, International Conference on Harmonisation.