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

Can CRAs (monitors) review source documents of subjects who have withdrawn consent?

1. Yes, they can review past documents

2. No, they cannot review any documents

3. Only if authorized by the investigator

4. Only if the documents are de-identified

The correct answer is: Yes, they can review past documents

CRAs (Clinical Research Associates or monitors) are responsible for overseeing the conduct of clinical trials and ensuring that data collected is accurate and consistent with the regulatory requirements and study protocol. When a subject withdraws consent, it is important to respect their autonomy and confidentiality. However, the review of past documents can be justified in certain contexts. Reviewing past documents after a subject has withdrawn consent can be permissible because this action typically pertains to ensuring that the data already collected up until the point of withdrawal is accurate and has been properly handled. The purpose of this review is to ascertain compliance with the trial protocols and to assess the integrity of the data that has already been gathered prior to the withdrawal of consent. As regulations often allow for the review of data collected before a participant's withdrawal, this supports the rationale behind the correctness of this answer. This practice aligns with regulatory guidelines that prioritize both the ethics of patient consent and the necessity for data integrity in clinical research. Data that has already been obtained typically remains subject to oversight, because it is crucial for ensuring the final analysis and overall validity of the trial's conclusions. Therefore, CRAs are permitted to review source documents of subjects who have previously participated in the study, even after they have opted out.