How are protocol amendments properly managed in GLP?

• A. They must be approved by responsible authorities, documented as amendments, and incorporated into the study plan.
• B. They can be made informally and circulated as a memo.
• C. No amendments are allowed after protocol finalization.
• D. They are recorded only in the investigator’s notebook.

Answer: (A)

In GLP, protocol changes are treated as formal amendments. They must receive written approval from the responsible authorities before being put into effect, and the changes are documented as an official amendment with date, rationale, and any impact on the study. The amendment is then incorporated into the study plan and the controlled documents that govern how the study is conducted. This approach preserves traceability, ensures the data generated align with the approved design, and keeps the study compliant with GLP requirements. Recording changes only in an investigator’s notebook or circulating informal memos does not provide the necessary audit trail, and assuming no amendments are allowed contradicts standard GLP practice, since amendments are a normal part of managing study protocols.