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

Who is primarily responsible for providing the clinical trial protocol?

1. The Investigator

2. The Sponsor

3. The Research Coordinator

4. The Regulatory Authority

The correct answer is: The Sponsor

The sponsor is primarily responsible for providing the clinical trial protocol. The protocol is a comprehensive document that outlines the objectives, design, methodology, statistical considerations, and organization of a clinical trial. It serves as a guide for all parties involved in the study, including investigators and research teams. The sponsor, which may be a pharmaceutical company, biotechnology firm, academic institution, or any organization that initiates and oversees a clinical trial, ensures that the protocol is compliant with regulatory requirements and ethical standards. They also play a critical role in the overall design of the study and in ensuring that sufficient resources are allocated for the trial. While the investigator may contribute to the development of the protocol and ensure that it is feasible from a clinical perspective, and the research coordinator assists in the execution of the protocol, the responsibility for its creation and provision lies with the sponsor. The regulatory authority, on the other hand, assesses and approves the protocol before the trial can commence but does not create it.