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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
Free Lesson Preview
The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
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Understand the CRC's unique position in the data chain, identify systemic threats to data quality, and develop strategies for protecting data integrity at the point of creation.
Consider a single blood pressure reading: 148/92 mmHg. A coordinator measures it at 10:17 a.m., records it on the source document worksheet, and enters it into the electronic data capture system. From that moment, the number passes through hands that never touched the participant, never watched the sphygmomanometer settle, never heard the participant mention they had just climbed three flights of stairs because the elevator was broken.
A clinical research associate reviews the entry during a monitoring visit, comparing it against the source worksheet. A data manager at the CRO runs it through programmatic edit checks. A medical monitor flags it as a potential safety signal. A biostatistician includes it in a blood pressure trend analysis across 200 participants. A regulatory reviewer at the FDA reads the summary table in a New Drug Application and notes the incidence of treatment-emergent hypertension.
Twelve people -- or more -- will handle that number before it influences a regulatory decision about whether a drug reaches the market. But only one of them was in the room when the measurement happened. Only one saw the participant's arm position, heard the mention of the stairs, noticed that the cuff size was borderline between regular and large. Only one had direct knowledge of the original clinical observation.
That person was the coordinator.
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