Which statement best describes pre-trial regulatory notification?

• A. It must be dated and identify the protocol
• B. It is optional
• C. It must include only the investigator's CV
• D. It is submitted after the trial begins

Answer: (A)

Pre-trial regulatory notification is a formal communication to the regulatory authority about the planned trial before it starts. The key requirement is that this notice is dated and clearly identifies the protocol being submitted. The date provides an auditable start-point and keeps the regulator’s records aligned with the exact trial and its approved plan, while identifying the protocol ensures the correct study is linked to the notification and can be reviewed against the approved details.

This isn't optional, and the notice isn’t limited to the investigator’s CV. It also shouldn’t be submitted after the trial begins; the purpose is to inform oversight bodies before initiation so they can review safety, ethics, and compliance aspects in advance.