Clinical OperationsGlossary Term
ICH E6(R3) Section 5.14
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
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.
Sample shipment
"The chain of custody form documented that the blood sample was collected by the phlebotomist at 0830, centrifuged and aliquoted by the coordinator at 0900, transferred to the freezer at 0915, and shipped to the central laboratory at 1400 with continuous temperature monitoring."
Drug distribution
"Chain of custody documentation demonstrated that the investigational product was manufactured on January 5, released on January 20, shipped to the distribution depot on January 25, forwarded to the site on February 3, received by the pharmacist on February 5, and stored under appropriate conditions until dispensed."
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.
A computerized system used in clinical trials to manage randomization, treatment allocation, drug supply, and participant status through interactive web-based or telephone interfaces.
ICH E6(R3) Section 5.14
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
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.
Sample shipment
"The chain of custody form documented that the blood sample was collected by the phlebotomist at 0830, centrifuged and aliquoted by the coordinator at 0900, transferred to the freezer at 0915, and shipped to the central laboratory at 1400 with continuous temperature monitoring."
Drug distribution
"Chain of custody documentation demonstrated that the investigational product was manufactured on January 5, released on January 20, shipped to the distribution depot on January 25, forwarded to the site on February 3, received by the pharmacist on February 5, and stored under appropriate conditions until dispensed."
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.
A computerized system used in clinical trials to manage randomization, treatment allocation, drug supply, and participant status through interactive web-based or telephone interfaces.