How should the sponsor inform investigators about the need for record attention?

• A. Verbal
• B. In Writing
• C. Email
• D. Through the sponsor's counsel

Answer: (B)

Communicating about record attention should be done in writing because written notices create a durable, verifiable trail that supports regulatory compliance and proper documentation in the trial master file. A formal written notice clearly states what records need attention, what actions are required, who is responsible, and by when, so the investigator can reference it later and ensure consistent follow-through during source data verification and audits. Verbal reminders can be forgotten or misinterpreted, and while email is a form of writing, the emphasis on formal written communication helps avoid ambiguity and ensures there is an official record. Communicating "through the sponsor's counsel" adds unnecessary steps for routine record-keeping changes and is not required for standard notices.