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

Can Clinical Research Coordinators (CRCs) who are qualified physicians adjust investigational product (IP) doses?

1. Yes, they can adjust IP doses regardless of their qualifications.

2. No, they cannot adjust IP doses even if qualified.

3. Yes, but only under supervision.

4. No, unless requested by the regulatory authorities.

The correct answer is: No, they cannot adjust IP doses even if qualified.

The response highlights an important regulatory framework and ethical considerations surrounding the role of Clinical Research Coordinators (CRCs) in clinical trials. CRCs, even when they are qualified physicians, typically do not have the authority to adjust investigational product (IP) doses. This restriction is rooted in the structured oversight and governance required in clinical research to ensure patient safety and adherence to the study protocol. The primary responsibility for making dosage adjustments is usually reserved for the principal investigator (PI) or other designated medical personnel closely involved in the trial's administration. This ensures that any changes to the treatment regimen are made based on a comprehensive understanding of the study's design, objectives, and safety monitoring requirements. The integrity of clinical trials relies heavily on adherence to established protocols, which includes dose specifications that were determined based on preclinical and preliminary data. Regulatory authorities, such as the FDA or EMA, also establish guidelines that emphasize the roles and responsibilities of various team members in clinical research, further reinforcing that any decisions that might affect participant safety or data integrity should not rest solely on CRCs—even if they possess medical qualifications. In summary, the guiding principle is that CRCs should not make independent adjustments to IP doses; this task is explicitly reserved for those who are designated and qualified