Free Lesson Preview
This is just the beginning
The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
View enrollment optionsAlready enrolled? Sign in
Free GCP training
Professional tracks
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.
View enrollment optionsAlready enrolled? Sign in
Define and apply each element of the ICH E6(R3) data integrity criteria with specific CRC-relevant examples, and distinguish the E6(R3) framework from the industry ALCOA-CCEA mnemonic.
A coordinator sits at a workstation and enters a blood pressure reading into the electronic data capture system: 142/88 mmHg. It takes perhaps five seconds. The number appears in the field, the edit check accepts it, and the coordinator moves on to the next data point.
But that single entry -- those six characters -- must satisfy eight distinct criteria before anyone can trust it. The reading must be traceable to the person who measured it. It must be readable without ambiguity. It must have been recorded at or near the time the measurement was taken. It must reflect the original observation, not a recopied or reconstructed value. It must match what the sphygmomanometer actually displayed. It must include everything required -- the date, the time, the position, the arm, the device. It must be protected from unauthorized alteration. And the process that produced it must be dependable enough that a different coordinator, following the same procedure, would generate an equally trustworthy result.
That is the burden every data point carries in a clinical trial. And the clinical research coordinator is the person who bears it first.
Progress saves itself — finish reading and this lesson completes