Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam 2026 - Free ACRP Practice Questions and Study Guide

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

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

No, they cannot adjust IP doses even if qualified.

Yes, but only under supervision.

Clinical Research Coordinators (CRCs), regardless of their qualifications, are typically not authorized to adjust investigational product (IP) doses. Their role primarily involves overseeing the day-to-day operations of clinical trials, including participant interaction, data collection, and compliance with the study protocol. While a CRC may have medical qualifications, their authority to modify treatment regimens, including dose adjustments, is limited by regulatory standards and trial protocols.

The rationale behind this limitation is grounded in the need for consistency in how investigational therapies are deployed during clinical trials. Dosage adjustments can significantly affect trial outcomes, integrity, and participant safety. Therefore, any such changes must be made under strict adherence to the study design and generally involve physicians or investigators directly responsible for patient care within the study's framework.

In contrast, the options suggesting that CRCs can adjust doses on their own or under specific conditions imply a level of autonomy that is not typically granted in clinical research settings, where safety and protocol fidelity are paramount. Hence, the assertion that CRCs cannot adjust IP doses, regardless of their qualifications, aligns with the established guidelines governing clinical research practices.

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No, unless requested by the regulatory authorities.

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