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

If changes to safety language in an Investigator's Brochure (IB) are not submitted to the Institutional Review Board (IRB), it indicates a decreased concern for participant safety. This is because the safety language in the IB is crucial for informing the IRB about any potential risks associated with the clinical trial. The IRB is responsible for protecting the rights and welfare of research participants, and any revisions to safety information must be communicated to them to ensure oversight and an up-to-date understanding of the risks involved. When these changes are ignored, it reflects a lack of diligence in monitoring participant safety, which is vital for ethical research conduct. Ensuring that the IRB is aware of safety updates is integral to maintaining the safety and rights of participants throughout the study.