Compliance, Privacy & Quality

GCP concepts, Part 11 principles, privacy expectations, and inspection readiness.

14 terms

Practical principles for data integrity: attributable, legible, contemporaneous, original, accurate, plus complete/consistent/enduring/available.

A documented nonconformance identified during audit or inspection.

Corrective and preventive action plan to address root causes of quality issues.

Action taken to fix an identified issue and restore compliance/quality.

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GCP concepts, Part 11 principles, privacy expectations, and inspection readiness.

14 terms

Practical principles for data integrity: attributable, legible, contemporaneous, original, accurate, plus complete/consistent/enduring/available.

A documented nonconformance identified during audit or inspection.

Corrective and preventive action plan to address root causes of quality issues.

Action taken to fix an identified issue and restore compliance/quality.

Data Integrity

Ensuring data are complete, consistent, accurate, and attributable over time.

Deviation is protocol noncompliance; discrepancy is a data inconsistency.

Ongoing state of documented processes, traceability, and controlled records.

Collect only what is needed for protocol endpoints and safety assessment.

Clinical operations activity that may trigger data review and SDV findings impacting CDM.

Action that prevents recurrence by addressing root cause rather than symptoms.

Designing forms and workflows to reduce collection of identifiers and limit exposure.

Structured method to identify the underlying cause of recurring issues.

Plan specifying which data will be source-verified and at what frequency.

Record of who was trained, when, on which materials and system versions.