Good Clinical Practice (GCP) Compliance Audit

Start of the Workflow/Process.

Retrieve the specific clinical study details and site information from the Study Data Model to define the audit boundaries.

Create a task for the Lead Auditor to review the scope and formally assign an auditing team.

Create a new entry in the Audit Plan Data Model containing the audit date, methodology, and checklist requirements.

Create a task for the auditor to review essential regulatory documents (e.g., Investigator Brochure, Protocol).

Fetch all relevant regulatory documents from the Document Management Data Model for the selected study.

Create a task for the active inspection phase where the auditor verifies source data against the CRF.

Update the Audit Finding entry with specific details, severity (Major/Minor/Critical), and evidence descriptions.

Create a new entry in the Deviation Tracking model whenever a non-compliance issue is identified during the audit.

Aggregate all entries in the Audit Findings model to provide a total count of Major and Minor deviations found.

Execute a formula to calculate the overall compliance percentage based on the ratio of passed vs. failed audit checkpoints.

Create a task for the Study Manager to initiate Corrective and Preventive Actions (CAPA) for all critical findings.

Update the main Audit Entry status to 'Closed' once all findings have been addressed and signed off.

Create a comprehensive PDF/Report summarizing the scope, findings, and compliance score for regulatory submission.

Send an email to the Clinical Operations Director and Sponsor with the final Audit Report attached.

Send an SMS to the Quality Assurance Lead if a 'Critical' level finding is recorded during the audit.

End of the Workflow/Process.