SOCRA CCRP Practice Exam 2025 – The Complete All-in-One Guide to Master Your Certification!

Question: 1 / 400

How is source data defined by ICH GCP guidelines?

As digital data only

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.

Get further explanation with Examzify DeepDiveBeta

Only paper-based documents

Communications with regulatory authorities

Next Question

Report this question

Download SOCRA CCRP Practice Exam 2025 – The Complete All-in-One Guide to Master Your Certification! PDF Study Guide
Subscribe

Get the latest from Examzify

You can unsubscribe at any time. Read our privacy policy