SOCRA CCRP Practice Exam

When can a CRF be considered a source document?

1. When it is submitted to the IRB

2. When it is digitalized

3. When it is stored in a secure location

4. When CRF is signed, dated, and initialed by the person recording the information

The correct answer is: When CRF is signed, dated, and initialed by the person recording the information

A CRF (Case Report Form) is a document used to collect and record data during a clinical trial or patient study. A CRF can be considered a source document when it is the original document that contains the raw data, such as a patient's medical history, lab results, or other study-related information. This means that the data on the CRF is directly obtained from the source, without any alterations or interpretations. Therefore, options A, B, and C are incorrect because they do not relate to the originality of the data on the CRF. Option A refers to the submission of the CRF to the IRB (Institutional Review Board), which is a process that ensures the protection of human subjects in a research study but does not affect the CRF's status as a source document. Option B refers to the digitalization of the CRF, which is simply a