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

How should a subject be identified on immediate and follow-up reports after a Serious Adverse Event occurs?

1. By their name

2. By their study group

3. By their subject identification number

4. By their medical record number

The correct answer is: By their subject identification number

Using the subject identification number to identify a subject on immediate and follow-up reports following a Serious Adverse Event (SAE) is the appropriate choice. This method ensures confidentiality and minimizes the risk of personal information being disclosed. The subject identification number is unique to each participant in a study, allowing for accurate tracking and documentation of events related to that particular subject without compromising their privacy. This method adheres to ethical guidelines and regulatory requirements that protect participant identities in clinical research. In contrast, identifying subjects by their name would violate privacy protocols and could lead to unintentional disclosure of personal information. Referring to a study group may not provide specific information about the individual, as multiple subjects could belong to the same group, leading to potential confusion. Using a medical record number could similarly risk exposing sensitive health information and may not be unique to the study context, potentially complicating data management and participant tracking.