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Classification and analysis of the GCP inspection findings ...

01 December 2014 INS/GCP/46309/2012 compliance and Inspections Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP ( inspection reports to EMA 2000-2012) 30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5505 Send a question via our website European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. TABLE OF CONTENTS 1. GLOSSARY .. 3 2. INTRODUCTION .. 4 3. SCOPE AND AIMS .. 6 4. METHOD .. 6 INFORMATION ABOUT findings .. 6 INFORMATION ABOUT THE APPLICATIONS .. 7 INFORMATION ABOUT THE clinical TRIAL(S) INSPECTED.

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well -being of trial subjects are

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