Biorepositories for NCI-Sponsored Cancer Clinical Trials

Quality Assurance

The CGB have developed Quality Assurance (QA) systems for measuring and documenting the capabilities to plan, execute and track the collection, processing, storage, distribution and usage of biorepository specimens in order to ensure the quality of the specimens for downstream usage. The purpose of the QA program is to minimize and account for variability in the conditions to which biospecimens are subjected while in the custody of the repositories.  The QA programs explicitly specify the facilities, equipment, and procedures required for repository activities and for maintaining secure, restricted and stable environments for the biospecimens.

While each bank has their own QA program to assure the quality of specimens, a common feature of all programs is thorough record keeping that adequately encompasses specific activities of the biorepository.