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

What is an essential requirement before a clinical trial site can begin subject enrollment?

1. Approval of the study protocol by the IRB/IEC

2. Completion of preclinical studies

3. Acquisition of investigational product

4. Signing a clinical trial agreement with the sponsor

The correct answer is: Signing a clinical trial agreement with the sponsor

The essential requirement before a clinical trial site can begin subject enrollment is the approval of the study protocol by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC). This step ensures that the study has been ethically reviewed and meets the necessary regulatory standards to protect the rights and welfare of the study participants. The protocol outlines the study's objectives, design, methodology, statistical considerations, and ethical considerations, and obtaining IRB/IEC approval is crucial for ensuring that these aspects comply with relevant regulations and ethical guidelines. While other requirements, such as completing preclinical studies, acquiring the investigational product, and signing a clinical trial agreement with the sponsor, are important in the study initiation process, they do not directly impact the ability to enroll subjects. For enrollment to commence, the protocol must first receive ethical approval to ensure participant safety and ethical conduct throughout the trial. Thus, obtaining the approval from the IRB/IEC is paramount in the timeline of securing all necessary components to conduct a clinical trial.