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

What must a site have in place before it can begin enrolling subjects in a phase 3 trial after receiving IRB/IEC approval?

1. A signed clinical trial agreement with the sponsor

2. Approval from the regulatory authority

3. Training certification for all staff

4. All ethical review board approvals

The correct answer is: A signed clinical trial agreement with the sponsor

For a site to begin enrolling subjects in a phase 3 trial after obtaining IRB/IEC approval, it is essential to have a signed clinical trial agreement with the sponsor. This agreement outlines the responsibilities and expectations of both the sponsor and the site, including budget considerations and compliance with regulatory requirements. Having this agreement in place ensures that the site is authorized to conduct the trial and is aware of the sponsor's obligations regarding compensation for the site's services, coverage for the subjects, and other logistical aspects critical to the conduct of the trial. While it is true that regulatory authority approval and training certifications for all staff are important factors in clinical trial readiness, these components typically do not represent the primary condition for commencing subject enrollment. Ethical review board approvals are also necessary and include IRB/IEC approval as one aspect of ensuring the study's ethical conduct. However, without the clinical trial agreement signed by both parties, the site lacks the formalized authorization to proceed with enrollment activities, making it the most crucial element at this stage.