ICHGCP英文版（可编辑） .doc

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1、ICH-GCP英文版 European Medicines Agency July 2002 CPMP/ICH/135/95 ICH Topic E 6 (R1) Guideline for Good Clinical Practice Step 5 NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95) TRANSMISSION TO CPMP July 1996 FINAL APPROVAL BY CPMP July 1996 DATE FOR COMING INTO OPERATION January 1997 POST

2、 STEP ERRATA (linguistic minor corrections) July 2002 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: mail ?EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is a

3、cknowledged GUIDELINE FOR GOOD CLINICAL PRACTICE ICH Harmonised Tripartite Guideline INTRODUCTION .5 1. GLOSSARY.5 1.1 A D R (ADR).5 DVERSE RUG EACTION 1.2 A E (AE).5 DVERSE VENT 1.3 A ( ) .6 MENDMENT TO THE PROTOCOL 1.4 A R R ( ).6 PPLICABLE EGULATORY EQUIREMENT S 1.5 A ( I R B ).6 PPROVAL IN RELAT

4、ION TO NSTITUTIONAL EVIEW OARDS 1.6 AUDIT .6 1.7 AUDIT CERTIFICATE.6 1.8 AUDIT REPORT .6 1.9 A T .6 UDIT RAIL 1.10 B /M .6 LINDING ASKING 1.11 C R F (CRF) .6 ASE EPORT ORM 1.12 C T /S .7 LINICAL RIAL TUDY 1.13 C T /S R .7 LINICAL RIAL TUDY EPORT 1.14 COMPARATOR (PRODUCT) .7 1.15 COMPLIANCE (IN RELATION TO TRIALS) .7 1.16 CONFIDENTIALITY .7 1.17 CONTRACT .7 1.18 COORDINATING COMMITTEE.7 1.19 COORDINATING INVESTIGATOR .7 1.20 CONTRACT RESEARCH ORGANIZATION (CRO).