SOCRA CCRP Practice Exam

What is reviewed during Source Data Review (SDR) to ensure quality of a clinical study?

1. Marketing materials

2. Source documentation

3. Financial records

4. Patient questionnaires

The correct answer is: Source documentation

Source Data Review (SDR) is a process used to validate the accuracy and completeness of clinical trial data by reviewing source documents, such as medical records, laboratory reports, and other relevant documents. This includes reviewing the informed consent form, enrollment and eligibility criteria, and other documentation related to study procedures. Options A, C, and D are not reviewed during SDR because they do not directly pertain to the quality of the clinical study itself. Financial records may be reviewed during a different process, such as budget review, but they do not relate to the accuracy and completeness of the data collected. Patient questionnaires may be used to collect data, but they are not considered source documentation and therefore would not be reviewed during SDR.