What documentation describes shipment dates, batch numbers, and method of shipment for investigational products to enable tracking and accountability?

• A. Updates of Medical/Lab/Technical Procedures/Tests Certification, Accreditation, Established QC and/or External QA, or Other Validation
• B. Documentation of Investigational Products Shipment
• C. Source Documents
• D. Signed Informed Consent Forms

Answer: (B)

Tracking and accountability for investigational products relies on a record that documents when shipments occurred, which batch or lot was sent, and how the shipment was delivered. This Documentation of Investigational Products Shipment provides that exact information, creating a traceable chain of custody from sponsor to site and allowing inventory reconciliation, verification of proper storage conditions, and audit readiness.

Other records serve different purposes: source documents capture data on study subjects and procedures, informed consent forms document that participants agreed to partake in the trial, and general QA or validation records cover quality system activities rather than the movement of investigational products.