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

When can a site in the start-up phase of an industry-sponsored Phase 3 trial begin enrolling subjects?

1. Immediately after IRB/IEC approval

2. After a signed clinical trial agreement with the sponsor is in place

3. Once the investigational product is received

4. After completion of site initiation training

The correct answer is: After a signed clinical trial agreement with the sponsor is in place

In the context of a site starting up for an industry-sponsored Phase 3 trial, enrolling subjects is contingent upon several essential preparatory steps aligning correctly. A signed clinical trial agreement with the sponsor is crucial because it legally formalizes the relationship between the site and the sponsor, outlining the responsibilities, expectations, and financial arrangements for the trial. Only after this agreement is in place can the site ensure that it has the right to enroll subjects and that all parties are aligned with the trial’s objectives and requirements. While IRB/IEC approval is a necessary step for ethical oversight and to ensure the safety and well-being of participants, and receiving the investigational product and completing site initiation training are important steps in the overall trial preparation, they cannot independently authorize subject enrollment unless the clinical trial agreement has first been executed. This agreement is the foundation that provides the necessary legal and operational framework for the trial to proceed, thus ensuring the site is compliant and ready for subject recruitment. In summary, the presence of a signed clinical trial agreement is the critical milestone that enables a site in the start-up phase to begin enrolling subjects in a Phase 3 trial.