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

Are changes to an Investigator's Brochure (IB) required to be submitted to the IRB/IEC?

1. Yes, all changes must be submitted

2. No, changes are not required

3. Only specific safety language changes must be submitted

4. Changes only need submission if critical

The correct answer is: Only specific safety language changes must be submitted

The correct approach is to understand that specific safety-related changes in the Investigator's Brochure (IB) must indeed be submitted to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC). This requirement arises from the need to keep the IRB/IEC informed about any modifications that may impact the safety and well-being of the study's participants. Safety language in the IB serves a crucial role as it contains key information about the potential risks and benefits of the clinical trial. When there are updates or changes to this safety information, it is imperative that these changes are communicated to the IRB/IEC to ensure that the ethical oversight of the study is maintained. This process helps protect participants and ensures that the IRB/IEC can reassess the ethical considerations of the research study based on the most current data available. The other responses suggest broader or less comprehensive requirements than what is mandated. For instance, stating that all changes must be submitted may lead to unnecessary administrative burdens, while suggesting that no changes need to be submitted does not align with the essential role of the IRB/IEC in participant safety. Additionally, indicating that only critical changes must be submitted could overlook the importance of specific safety updates that, while not deemed critical, could still