Transcription of E6 Step 5 Good clinical practice R1
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E6 Step 5 Good clinical practice R1
European Medicines Agency 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: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged 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 STEP ERRATA (linguistic minor corrections) July 2002 EMEA 2006 2 TABLE OF CONTENT INTRODUCTION .. 5 1. GLOSSARY .. 5 ADVERSE DRUG REACTION (ADR) .. 5 ADVERSE EVENT (AE).. 5 AMENDMENT (TO THE PROTOCOL) .. 5 APPLICABLE REGULATORY REQUIREMENT(S) .. 5 APPROVAL (IN RELATION TO INSTITUTIONAL REVIEW BOARDS) .. 5 AUDIT .. 5 AUDIT CERTIFICATE.
monitoring board, monitoring committee, data monitoring committee) ... 5.13 manufacturing, packaging, labelling, and coding investigational product(s) ...
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