Detailed Explanation
Chain of custody documentation creates an unbroken record of who has had possession of controlled materials and what has been done with them at each stage of their journey through the clinical trial. This documentation is essential for investigational products to demonstrate that materials were properly handled and stored throughout, and for biological samples to establish that specimens submitted for analysis actually came from the claimed source and were collected under proper conditions. Complete chain of custody enables reconstruction of material handling history and supports regulatory inspection readiness.