Before starting the trial, how should regulatory submissions be dated?

• A. They must be dated and contain information identifying the protocol
• B. They must be unsigned
• C. They must be submitted after the trial starts
• D. They must include the final protocol only

Answer: (A)

Dates on regulatory submissions are essential for traceability and version control. Before the trial begins, the submission should be dated and clearly identify the protocol version it relates to (including protocol title and date) so regulators can match the approval to the exact protocol in effect. This ensures an auditable trail and prevents confusion if multiple protocol amendments exist. Submissions should be properly authorized (signed) and include the necessary regulatory documents beyond just the final protocol, all tied to the correct protocol version.