In GLP, a study is not considered complete until what occurs?

• A. The archive is created
• B. The final report is signed
• C. The QA audit is completed
• D. The raw data is transferred to the sponsor

Answer: (B)

In GLP, the official close of a study happens when the final report is signed by the Study Director. That signature signals that the report has been reviewed, approved, and accurately reflects the study’s design, conduct, data, and conclusions. The final report is the formal, auditable document that documents what was planned, what was done, what was found, and what it means. Without this signature, the study isn’t considered complete because there’s no validated record of its outcomes.

Other activities like creating the archive, completing the QA audit, or transferring raw data to the sponsor are essential parts of GLP practice to ensure integrity, traceability, and proper data handling, but they do not by themselves mark the completion of the study. Archiving preserves records for future access; QA audits verify compliance and data integrity; transferring data to the sponsor facilitates dissemination. The signed final report ties all of these elements together into a formally completed study.