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.

For investigational products, chain of custody spans from manufacturing through delivery to participants. Manufacturing records document production and release. Shipping documentation tracks transport from depot to site, including temperature monitoring during transit. Site receipt records confirm arrival and condition. Storage logs document ongoing conditions. Dispensing records transfer custody to participants. Return and destruction records complete the lifecycle. Each transition requires contemporaneous documentation identifying who transferred the material, who received it, when the transfer occurred, and the condition of the material.

Biological sample chain of custody begins at collection and extends through analysis and any subsequent archival or destruction. Collection records document participant identity, collection time, and specimen type. Processing records describe any manipulations performed. Shipping records track transport to laboratories. Laboratory receipt and storage records continue the chain. Analysis records link results to specific specimens. This comprehensive documentation enables verification that reported results actually derive from the correct participant samples collected under proper conditions.