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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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Determine when EMR data qualifies as source documentation, identify common pitfalls of clinical records in research, and apply strategies to make EMR data research-ready.
A monitor arrives for a routine visit and asks the coordinator to pull the source for a potassium result entered in the CRF. The coordinator opens Epic, navigates to the laboratory results tab, and points to the screen: potassium 5.2 mEq/L, drawn on 14 February 2026 at 0742, reported at 0918. The value matches the CRF entry exactly. The monitor nods -- then says, "This is not adequate as source."
The coordinator is confused. The value is right there. It matches. The laboratory generated the result. What is the problem?
The problem is not the potassium value. The problem is that the source data identification log for this study specifies "certified laboratory printout filed in the participant research binder" as the source document for laboratory results. The EMR screen display is not a printout. It has not been certified. And the monitor cannot verify a screen that may display differently tomorrow if the laboratory issues a correction or the system undergoes an update. The data are correct, but the source documentation pathway has not been followed.
This scenario plays out at study sites every week. The electronic medical record is an extraordinary clinical tool -- it contains a wealth of participant data, it is timestamped, it has audit trails. But its role as source documentation in clinical research is more nuanced, more limited, and more treacherous than many coordinators realize. The EMR is sometimes the ideal source. It is sometimes inadequate. And the difference hinges on decisions that must be made before the first participant ever walks through the door.
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