SOCRA CCRP Practice Exam

How are source documents defined according to ICH GCP guidelines?

1. As certified copies of original documents

2. Original documents, data, and records

3. Only electronic records

4. Only patient diaries

The correct answer is: Original documents, data, and records

Source documents, according to ICH GCP guidelines, refer to original documents, data and records that contain information related to a clinical trial, research or patient health. Option A is incorrect because certified copies of original documents do not contain original information and may not be accurate representations. Option C is incorrect because while electronic records can be considered as source documents, it is not the only type that is included in this definition. Option D is incorrect because patient diaries are considered as source documents only when they contain original information or data. Therefore, the correct answer is B.