3 years ago

Clinical Research Experience

Clinical Research Experience

Statistical monitoring

Statistical monitoring of data (rather than physical monitoring of sites) • Standard checks of range, consistency and completeness of data • Checks for unusual distribution of data within and between study sites (e.g. too little variance; lack of outliers; unlikely dates) • Quality control assessments in random samples of investigators, patients and data items (supplemented by systematic checks of particular sites prompted by other analyses)

EXPECTED number of patients with at least one reported SAE Example: SAE rates by study site 0 50 100 150 200 O–E < -50 LESS than expected O–E < -20 MORE than expected 0 50 100 150 200 OBSERVED number of patients with at least one reported SAE

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