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Good Clinical Practice (GCP) inspection program

Guidance for GCP inspection of clinical trial sites for investigational biologicals and medicinal products
12 May 2022
Download Good Clinical Practice (GCP) inspection program

Description

Following a successful pilot program, the TGA is implementing the ongoing risk-based Good Clinical Practice (GCP) Inspection Program.

About the Good Clinical Practice Inspection Program

Clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA's Good Clinical Practice (GCP) Inspection Program.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Compliance with GCP provides assurance that the rights, safety and well-being of clinical trial participants are protected and that the trial data generated are credible.

This guidance describes:

  • how we prioritise and schedule GCP inspections
  • the kinds of inspections we might conduct
  • the inspection process, and
  • how we report and follow-up on inspection.

Contacts

For any GCP-related enquiries, please email GCP.Inspection@health.gov.au.

  • Introduction
  • Inspection process
  • Inspection reports
  • Inspection follow-up
  • Compliance and enforcement
  • Records management
  • Publishing GCP inspection data
  • Grading deficiencies

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