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

Under what condition can a Clinical Research Coordinator adjust the dose of the Investigation Product for a subject?

1. When they are a licensed pharmacist

2. Only if they have a medical degree and are delegated this responsibility by the PI

3. When the subject requests a change

4. When it is documented in the protocol

The correct answer is: Only if they have a medical degree and are delegated this responsibility by the PI

The correct answer is provided based on the responsibilities and regulations governing the role of a Clinical Research Coordinator (CRC). In clinical research, the adjustment of the dose of an Investigational Product (IP) is a significant decision that primarily falls under the jurisdiction of a licensed medical professional, typically the Principal Investigator (PI). A CRC acting in accordance with established protocols and regulatory frameworks must adhere strictly to the guidelines laid out in the clinical study protocol. If the protocol specifies that dose adjustments can only be made by a qualified medical professional, then only those with the requisite medical training and appropriate delegations from the PI can carry out this task. While a licensed pharmacist has expertise in medication management and could technically adjust doses based on their training, without delegation from a PI in the context of clinical research, they may not have the authority to do so. Similarly, a subject's request to change the dose does not constitute a clinical justification; dose adjustments must be based on clinical criteria and protocol specifications. Thus, the evidence from the research protocol is paramount, as it provides the approved framework for making such critical clinical decisions. When documented in the protocol, it outlines the specific conditions under which a CRC may operate, ensuring patient safety and adherence to regulatory standards.