Good Clinical Practice inspectorate

Vincent Yeung has recently joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a Good Clinical Practice Inspector. He had been working at Great Ormond Street Hospital for 17 years he has specialised in clinical trials, research ethics, and metabolic and HIV medicine. He is an honorary lecturer at the Centre for Paediatric Research, University of London. His views in this book do not represent the view or official position of the MHRA. 

Premises where clinical studies are to be conducted are open to inspection by the GCP Inspectorate set up by the MHRA in accordance with the EU Directive on good clinical practice. The inspectorate is required to give a preliminary oral report at the conclusion of the inspection and a written report within 30 days. 

Detailed guidelines on the qualifications of inspectors who should verify compliance in clinical trials with the provisions of good clinical practice for an investigational medicinal product to implement the directive on Clinical Trials on medicinal products for human use. June 2002. http //pharmacos.eudra.org./F2/%20pharmacos/docs/Doc2002/june/ins gcp 06 2002.pdf. 

To verify compliance with the provisions on good clinical and manufacturing practice. Member States shall appoint inspectors to inspect... 

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