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Duration: Certification: Languages: Related Resources: QUESTION SETTING AND STUDY DESIGN |
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:
- The procedures involved in planning, conducting and reporting inspections/audits, specifically at clinical investigator sites.
- 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’ also available on the Global Health Training Centre.
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
Congratulations! You are about to start a free course, a donation would help keep this access free for you, and everyone across the world.
Acknowledgements
The Global Health Training Centre is built through the support and partnership of 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
Use and reproduction of these e-learning materials:
These e-learning materials are owned by The Global Health Network. You are free to share or adapt this material but you must attribute it to The Global Health Network using the link www.theglobalhealthnetwork.org.
For further information please see our FAQ page.
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