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

What must be documented if a subject consistently adheres to the protocol but forgets to bring back medication?

1. Her current medication dosage

2. Document the incident as a major protocol violation

3. Record that she has forgotten the medication in the source document

4. Cancel her participation in the study

The correct answer is: Record that she has forgotten the medication in the source document

The necessity to document that the subject has forgotten the medication in the source document is essential for several reasons. First, accurate documentation ensures that all events and behaviors related to the study are recorded, which is crucial for maintaining the integrity of the trial data. This record helps to provide context for the subject's adherence to the study protocol, demonstrating that while the subject is compliant overall, there was an isolated incident of forgetting the medication. Furthermore, this documentation serves as a basis for potential future interactions with the participant and allows study personnel to address any issues regarding medication adherence effectively. Additionally, it is important for the ongoing evaluation of participant safety and overall study validity. If this incident is recorded, it can be taken into account when analyzing data or making clinical decisions regarding the participant's continued involvement in the study. This systematic approach to documenting minor lapses ensures no disruption to the trial’s objectives and can provide insights for managing similar situations in the future. The incorrect options suggest misrepresenting the significance of the incident; for instance, labeling the forgotten medication as a major protocol violation is disproportionate, as the participant has otherwise adhered to the study's requirements. Likewise, canceling participation or focusing solely on current medication dosages detracts from the primary objective of maintaining detailed