Course Overview

Duration:

This course should take 30-45 minutes to complete

Certification:

A certificate is issued once a minimum of 80% is achieved in the final quiz section.

Summary:

This course is intended to benefit regulatory good clinical practice (GCP) inspectors and sponsor auditors who audit clinical trials in particular:

  • Regulatory authorities or sponsors in the process of building up their GCP inspection/audit team and an inspection/audit programme
  • Regulatory authorities or sponsors which require further, up to date training in the planning, conduct and reporting of GCP inspections/audits for their inspection/audit team.

Objectives:

Upon completion of this course, you will have an understanding of:

  1. The procedures involved in planning, conducting and reporting inspections/audits, specifically at clinical investigator sites.
  2. Some of the general principles described could also be used when conducting inspections at other sites e.g. those of the sponsors and contract research organisations (CRO).

Prerequisite:

It is recommended that before commencing this course, participants may find it valuable to complete the course ‘ ICH Good Clinical Practice’ available on the Global Health Training Centre website (https://globalhealthtrainingcentre.tghn.org/elearning/)

There is the possibility for this course to be offered as a face to face training course in conjunction with an onsite national inspection at a clinical investigator site. This would provide the opportunity to gain hands-on experience in the conduct of an inspection by implementing the theoretical aspects of the course, into real life practice. For further information and details please contact training@theglobalhealthnetwork.org

Acknowledgements

The Global Health Training Centre is built through the support and partnership of the Bill and Melinda Gates Foundation, the World-Wide Antimalarial Resistance Network and the East African Consortium for Clinical Research.  

Author:

  • Thania Spathopoulou - National Organisation for Medicines, Greece. GCP Inspector seconded to the European Medicines Agency:

‘I would like to express my thanks to the National Organisation for Medicines, Greece and the European Medicines Agency for giving me the permission to design this course’

Editor:

  • Susan Bull - Head, GlobalHealthReviewers.org , and Senior Researcher, The Ethox Centre, Nuffield Department of Population Health, University of Oxford

Reviewers: 

  • Lisbeth Bregnhøj - Medicines Inspector, Danish Health and Medicines Authority
  • Gunnar Danielsson - Senior Expert, Pharmaceutical Inspector, Inspection Unit, Medical Products Agency, Sweden
  • Mimi Darko - Safety Monitoring & Clinical Trials Division, Food and Drugs Authority, Ghana
  • Barbara Malungu – Country Head/Director of PHACT-Uganda (Public Health Alliance for Clinical Trials) and Founder and President of TransContinental-QA (TCQA)
  • Ria Christine Siagian - Clinical Trial Section, The National Agency of Drug and Food Control, Indonesia