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.

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.