Transcription of I ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD …
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I ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD …
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL. REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE. ICH HARMONISED GUIDELINE . INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR good . clinical PRACTICE. E6(R2). Current Step 2 version dated 11 June 2015. At Step 2 of the ICH Process, a consensus draft text or GUIDELINE , agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Steering Committee to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Health Canada and Switzerland) for internal and external consultation, according to national or regional procedures. E6(R1). Document History New First Codification History Date Codification November 2005. E6 Approval by the Steering Committee under Step 2 27 E6. and release for public consultation. April 1995.
1 1 INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR 2 GOOD CLINICAL PRACTICE ICH 3 E6(R2) 4 INTRODUCTION 5 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for 6 designing, conducting, recording and reporting trials that involve the participation of human 7 subjects. Compliance with this standard provides public assurance that the rights, safety and
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Good Clinical Practice, HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE, Good Clinical, Practice, Guideline, Good clinical practice E6R2, Protocols and GCP, Preparing for Certification as a, Clinical, Clinical CAPA: Embedding Quality into Clinical Research, 22800 Federal Register /Vol. 73, 22800 Federal Register/Vol. 73