Once the experimental termination date is reached for an EPA study, its protocol remains in force until what occurs?

• A. The study is terminated automatically.
• B. The final report is signed.
• C. A new protocol is issued.
• D. The SOPs are updated.

Answer: (B)

In EPA GLP studies, the work stops on the experimental termination date, but the protocol remains in force until the final study report is signed. The signing of the final report marks formal completion and acceptance of all data, analyses, and conclusions, ensuring the study is properly documented and defensible. Only after this sign-off is the study considered closed and the protocol effectively ended. Updating SOPs or issuing a new protocol doesn’t automatically close the study, and automatic termination isn’t how GLP closure works, since the final report and its sign-off are the official closure step.