Delegation of Trial Activities Section
ICH E6(R3) separates delegation from the investigator’s retained responsibility: delegated persons or parties should be qualified and informed, and delegation records should be proportionate to the significance of the activities.
A Delegation of Trial Activities section states what work may be delegated, to whom, how suitability is established, and how delegation is documented and kept under investigator oversight.
Key details
Important caveats
Scope Boundary
Delegation requirements depend on the activity, clinical-practice context, applicable regulation, and site organization. Do not require documentation beyond what the governing requirements and risk justify.
Further guidance
Content
Describe categories of delegated activities, responsible persons/parties, qualification or information expectations, documentation of delegation, and relevant service-provider agreements.
Purpose
Make the allocation of trial responsibilities transparent without implying that responsibility itself is transferred away from the investigator.
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