Investigational Product Accountability Section
ICH E6(R3) treats investigational-product accountability as an operational responsibility distinct from simply describing the intervention. Controls should support product integrity, protocol use, participant safety, and traceable disposition.
An Investigational Product Accountability section explains how trial product receipt, storage, dispensing/use, return, reconciliation, and final disposition will be controlled and documented.
Key details
Important caveats
Scope Boundary
Product-accountability details depend on product type, route, trial design, local regulation, direct-to-participant supply, and sponsor arrangements; do not copy a drug-trial workflow into studies where it does not apply.
Further guidance
Content
Describe responsible roles and the processes for receipt, storage conditions, dispensing or administration, reconciliation, returns/retrieval, unused product, and documentation as applicable.
Purpose
Show how investigational product will remain controlled and traceable from receipt through final disposition.
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