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The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
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Clinical Research Coordinator
Full course · Data Collection and Source Documentation
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The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
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Parse the ICH E6(R3) definitions of source data and source documents, identify source for each data category, and understand certified copies and prospective source determination.
A monitor arrives for a routine visit and asks to see the source document for a participant's hemoglobin A1c result. The coordinator pulls the laboratory printout from the participant's research binder -- the original report generated by the hospital's laboratory information system, dated and identified with the participant's medical record number. The monitor verifies it against the CRF entry. It takes 30 seconds. No ambiguity.
Then the monitor asks a harder question: "Where is the source for this participant's self-reported exercise frequency?"
The coordinator pauses. The exercise frequency was collected verbally during the screening visit and entered directly into the EDC system. There is no separate paper record. There is no printout to pull. Is the CRF itself the source? Is the coordinator's memory of the conversation the source? The answer depends entirely on a decision that should have been made before the first participant was ever enrolled -- a prospective determination of what would serve as source for each type of data in the trial.
That moment of uncertainty -- a competent coordinator, a reasonable question, and no clear answer -- illustrates why this lesson exists. Knowing what qualifies as a source document is not an academic exercise. It determines whether your data can survive source data verification, and ultimately, whether they can survive an inspection.
Progress saves itself — finish reading and this lesson completes