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

During a multi-site clinical study, whose responsibility is it to report the subject recruitment rate?

1. The Study Sponsor

2. The Investigator

3. The CRA (Monitor)

4. The IRB

The correct answer is: The CRA (Monitor)

The responsibility to report the subject recruitment rate primarily falls on the Clinical Research Associate (CRA) or monitor. This role is essential in the oversight and management of the clinical trial, as the CRA is tasked with ensuring that the study is conducted in accordance with the protocol, applicable regulations, and ethical standards. One of the key aspects of this oversight includes monitoring recruitment progress across sites. The CRA works closely with the investigators to collect data on subject enrollment and ensure that recruitment targets are being met. This allows the CRA to identify any challenges or issues that may be impacting recruitment and to facilitate communication between the study sponsor and the sites. Additionally, the CRA assists in reporting this information back to the sponsor, who requires updates to assess trial progress and make informed decisions based on enrollment status. The study sponsor is typically involved in overall management but relies on the CRAs for detailed reporting on recruitment metrics. Investigators primarily focus on conducting the study at their site and ensuring patient safety, while the Institutional Review Board (IRB) has a different mandate, focusing on the ethical aspects of the study rather than operational metrics like recruitment rates. Thus, the CRA’s role in tracking and reporting recruitment rates is crucial for the successful execution of a multi-site clinical study.