What should the Title Page potentially include according to the guidelines?

• A. The product's marketing materials
• B. A confidentiality statement instructing investigators to treat the IB as confidential
• C. The sponsor's confidential ledger
• D. The trial's enrollment status

Answer: (B)

Confidentiality is a key feature of the Investigator’s Brochure. The Title Page should clearly state that the document is confidential and intended for investigators to treat it as such, which protects proprietary information about the investigational product and limits access to authorized personnel. The other items don’t fit on a Title Page: marketing materials aren’t part of the IB’s formal front matter, a sponsor’s confidential ledger isn’t a document element, and trial enrollment status isn’t information typically included on the Title Page. So the confidentiality statement best aligns with the page’s purpose and guidelines.