Reconciliations

Cross-system checks (e.g., SAE, labs, IXRS), mismatch handling, and documentation.

7 terms

Validate exports against expected counts, formats, and variable definitions.

Compare patient-reported outcomes from ePRO platform against EDC records.

Compare randomization and drug dispensation from IRT with EDC exposure data.

Check between lab vendor dataset and EDC to ensure alignment of results and units.

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Cross-system checks (e.g., SAE, labs, IXRS), mismatch handling, and documentation.

7 terms

Validate exports against expected counts, formats, and variable definitions.

Compare patient-reported outcomes from ePRO platform against EDC records.

Compare randomization and drug dispensation from IRT with EDC exposure data.

Check between lab vendor dataset and EDC to ensure alignment of results and units.

Protocol Deviation Reconciliation

Ensure deviations in CTMS/ops align with deviations recorded in EDC.

Record of reconciliation runs, findings, and closures across systems.

Process to ensure serious adverse events recorded in EDC match those in the safety system, resolving mismatches with documentation.