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

Is the signature page a required section of the Investigator's Brochure (IB)?

1. Yes

2. No

3. Only for Phase I trials

4. Only for Phase III trials

The correct answer is: No

The signature page is not a required section of the Investigator's Brochure (IB). The primary purpose of the IB is to provide comprehensive information about the investigational product to investigators and their staff involved in the clinical trial. It includes details regarding the preclinical and clinical data about the drug, its mechanisms, dosages, and potential risks. While a signature page can be useful for documenting that the investigator has read and understood the contents of the IB, it is not mandated by regulatory authorities or standard guidelines. Consequently, including a signature page is more of an administrative practice than a formal requirement. This understanding highlights that while the IB needs to contain crucial scientific information, the inclusion of a signature page does not hold the same significance and is not universally applicable to all stages of clinical trials, also reflected in the other choices which suggest specific circumstances or conditions where a signature page might be considered necessary.