Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Is the signature page of the Investigator's Brochure (IB) optional?

1. No, it is mandatory

2. Yes, it is optional

3. Only under certain conditions

4. It is optional for external auditors only

The correct answer is: Yes, it is optional

The best understanding of the signature page of the Investigator's Brochure (IB) is that it is indeed optional. The IB serves as a comprehensive document that outlines the clinical trial's methodology, background information, and safety data relevant to the investigational product. While the inclusion of a signature page can add an extra layer to confirm that investigators have acknowledged and understood the contents of the brochure, it is not a mandatory component of the document. The practice around the IB's signature page may vary across institutions and specific clinical trials, where obtaining a signature could be deemed useful to ensure compliance or acknowledgment. However, the regulatory requirements do not stipulate the necessity of a signature page for the IB to be considered valid or effective in informing trial participants and investigators about the study. Understanding the nature of the IB and its role in clinical studies is crucial, as it supports the dissemination of vital information but does not hinge on whether a signature page is included or not.