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ICH Topic E 6 (R1) Guideline for Good Clinical Practice

All involved agencies need to participate on this planning team from the outset to ensure a successful and safe event. At its initial meeting, the planning team should develop its mission and objectives, and determine the necessary components of the public safety plan. For example, what elements are within the realm of the promoter and what are within the realm of the public safety agencies? The planning team should also develop its structure using ICS as a model (that is, Sections, Branches, Divisions, and Groups, as needed). Chapter 3 will discuss ICS in greater detail | 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 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.eu.int http www.emea.eu.int EMEA 2006 Reproduction and or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged TABLE OF CONTENT INTRODUCTION.5 1. GLOSSARY.5 1.1 Adverse Drug Reaction ADR .5 1.2 Adverse Event AE .5 1.3 Amendment to the protocol .5 1.4 Applicable Regulatory Requirement s .5 1.5 Approval in relation to institutional Review Boards .5 1.6 Audit.5 1.7 Audit Certificate.6 1.8 Audit Report.6 1.9 Audit trail.6 1.10 Blinding Masking.6 1.11 Case Report Form CRF .6 1.12 Clinical Trial Study.6 1.13 Clinical Trial Study Report.6 1.14 Comparator Product .6 1.15 Compliance in relation to trials .6 1.16 Confidentiality.6 1.17 Contract.6 1.18 Coordinating Committee.6 1.19 Coordinating investigator.7 1.20 Contract Research Organization CRO .7 1.21 Direct Access.7 1.22 Documentation.7 1.23 Essential Documents.7 1.24 good Clinical Practice GCP .7 1.25 independent Data-Monitoring Committee IDMC Data and Safety Monitoring Board Monitoring Committee Data Monitoring Committee .7 1.26 Impartial Witness. 7 1.27 Independent Ethics Committee IEC .7 1.28 Informed Consent.8 1.29 Inspection.8 1.30 Institution medical .8 1.31 Institutional Review Board IRS .8 1.32 Interim Clinical Trial Study Report.8 1.33 Investigational Product.8 1.34 Investigator.8 1.35 Investigator Institution.8 1.36 Investigator s Brochure.8 1.37 Legally Acceptable Representative.8 1.38 Monitoring.9 1.39 Monitoring Report.9 1.40 Multicentre Trial.9 1.41 Nonclinical Study.9 1.42 Opinion in relation to Independent