In a very small GLP facility, who is permitted to be responsible for storing and retaining specimens and raw data?

• A. The study director, when also authorized as the archivist
• B. The QA officer
• C. The facilities manager
• D. The laboratory technician

Answer: (A)

In GLP, the long-term storage and retention of specimens and raw data must be assigned to a designated individual who is authorized to act as the archive custodian and who ensures records remain complete, retrievable, and protected. In a very small facility, the study director can take on the archival role if they are formally authorized as the archivist and there are documented procedures for archiving, access control, and retention. This aligns accountability with the study’s overall responsibility for data integrity.

The QA officer is focused on quality assurance and audits, not archival custody by default; the facilities manager oversees environment and maintenance, and a laboratory technician may handle samples or data but does not automatically carry archival responsibility unless specifically designated. Therefore, the best arrangement is the study director, authorized as the archivist, to be responsible for storing and retaining specimens and raw data.