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

When monitoring a study, which of the following should you look for in source documents?

1. Blurry original entries

2. Unobscured original entries

3. Untraceable records

4. Summary sheets only

The correct answer is: Unobscured original entries

In monitoring a study, it is crucial to ensure that source documents are clear and accurately reflect the information they are meant to provide. Unobscured original entries mean that the data recorded are legible and easily interpretable, which is vital for verifying the integrity and accuracy of the study data. Clear entries allow monitors to trace back the data to its original source without ambiguity, which strengthens the reliability of the study's findings. Maintaining unobscured original entries also aids in compliance with regulatory requirements and ensures that the study can withstand scrutiny during audits or reviews. When source documents are difficult to read or when entries are obscured, it raises concerns about data accuracy and the ability to verify the authenticity of the information, which can be detrimental to the integrity of the research. In contrast, blurred or untraceable records create uncertainty and hinder the monitoring process, while relying solely on summary sheets does not provide the depth of information needed to ensure comprehensive oversight.