Intervention Training Section
ICH E6(R3) links delegated trial work to appropriate qualification, information, and proportionate trial-related training. A focused intervention-training description can therefore document training that is specific to trial delivery rather than merely listing provider credentials.
An Intervention Training section describes any trial-specific training needed for staff or providers to deliver or support the intervention consistently and safely.
Key details
Important caveats
Scope Boundary
Training requirements depend on the intervention, delegated activities, local practice, sponsor processes, and risk. Do not duplicate provider-eligibility criteria or imply that one training package fits every trial.
Further guidance
Content
Describe who requires training, the intervention/protocol elements covered, who provides or verifies it, and any planned documentation or refreshers when relevant.
Purpose
Show how personnel will be prepared for trial-specific intervention tasks beyond their ordinary qualifications.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E6(R3) Good Clinical Practice Guidance for Industry — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current ICH E6(R3) GCP guidance on investigator oversight, training/delegation, participant withdrawal, investigational-product accountability, site close-out, essential records, and insurance/indemnification