Transcription of Guideline for good clinical practice E6(R2)
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Guideline for good clinical practice E6(R2)
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 5555 Send a question via our website European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged. 23 July 2015 1 EMA/CHMP/ICH/135/1995 2 Committee for Human Medicinal Products 3 Guideline for good clinical practice E6(R2) 4 Step 2b 5 Adopted by CHMP for release for consultation 23 July 2015 Start of public consultation 4 August 2015 End of consultation (deadline for comments) 3 February 2016 6 7 Comments should be provided using this template. The completed comments form should be sent to 8 9 Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/75 Document History 10 11 First Codification History Date New Codification November 2005 E6 Approval by the CPMP under Step 3 and release for public consultation.
Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 7/75 159 Introduction 160 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for 161 designing, conducting, recording and reporting trials that involve the participation of human subjects.
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