GOOD CLINICAL PRACTICE (GCP) COMPLIANCE AUDIT

Created by ChecklistGuro (https://checklistguro.com)

[ ] Fetch Audit Scope: Retrieve the specific clinical study details and site information from the Study Data Model to define the audit boundaries.
[ ] Assign Auditor: Create a task for the Lead Auditor to review the scope and formally assign an auditing team.
[ ] Initialize Audit Plan: Create a new entry in the Audit Plan Data Model containing the audit date, methodology, and checklist requirements.
[ ] Document Review Task: Create a task for the auditor to review essential regulatory documents (e.g., Investigator Brochure, Protocol).
[ ] Retrieve Regulatory Documents: Fetch all relevant regulatory documents from the Document Management Data Model for the selected study.
[ ] On-Site/Remote Inspection: Create a task for the active inspection phase where the auditor verifies source data against the CRF.
[ ] Log Observation: Update the Audit Finding entry with specific details, severity (Major/Minor/Critical), and evidence descriptions.
[ ] Create Deviation Record: Create a new entry in the Deviation Tracking model whenever a non-compliance issue is identified during the audit.
[ ] Calculate Total Findings Count: Aggregate all entries in the Audit Findings model to provide a total count of Major and Minor deviations found.
[ ] Calculate Compliance Score: Execute a formula to calculate the overall compliance percentage based on the ratio of passed vs. failed audit checkpoints.
[ ] CAPA Assignment: Create a task for the Study Manager to initiate Corrective and Preventive Actions (CAPA) for all critical findings.
[ ] Update Audit Status: Update the main Audit Entry status to 'Closed' once all findings have been addressed and signed off.
[ ] Generate Final Audit Report: Create a comprehensive PDF/Report summarizing the scope, findings, and compliance score for regulatory submission.
[ ] Notify Stakeholders: Send an email to the Clinical Operations Director and Sponsor with the final Audit Report attached.
[ ] Urgent Alert: Send an SMS to the Quality Assurance Lead if a 'Critical' level finding is recorded during the audit.

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