SOCRA CCRP Practice Exam

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How is source data defined by ICH GCP guidelines?

  1. As digital data only

  2. Information necessary for reconstruction and evaluation of the trial

  3. Only paper-based documents

  4. Communications with regulatory authorities

The correct answer is: Information necessary for reconstruction and evaluation of the trial

Source data, as defined by ICH GCP guidelines, refers to all information in original records/documents that represents the study participants' trial involvement. This includes data captured at the investigator site from study participants' source documents (medical records, pharmacy records, etc.), as well as data gathered directly from study participants during the course of the trial. Therefore, option A, which mentions only digital data, and option C, which mentions only paper-based documents, are incorrect as they do not encompass all forms of source data. Option D, which mentions communications with regulatory authorities, is also incorrect as it does not directly relate to the definition of source data.

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