Transcription of VICH Topic GL9 (GCP)
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VICH Topic GL9 (GCP)
The European Agency for the Evaluation of MedicinalProductsVeterinary Medicines and Information Technology Unit7 W estferry Circus, Canary W harf, London E14 4HB, UKSwitchboard (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47E-mail: 2000 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA isacknowledgedCVMP/VICH/595/98-FINALL ondon, 4 July2000 VICH Topic GL9 (GCP) Step 7 Consensus GuidelineGUIDELINE ON GOOD CLINICAL PRACTICESTRANSMISSION TO CVMPD ecember 1998 TRANSMISSION TO INTERESTED PARTIESD ecember 1998 COMMENTS REQUESTED BEFOREMay 1999 FINAL APPROVAL BY CVMPJuly 2000 DATE FOR COMING INTO OPERATION BYJuly 2001 FOR IMPLEMENTATION AT STEP 7 (FINAL) 06/00 Page 1 of 27 EMEA 2000 VICH GL9 (GCP)June 2000 For Implementation at Step 7 GGGGOOD CCCCLINICAL PPPPRACTICER ecommended for Implementationat Step 7 of the VICH Processon 15 June 2000by the VICH Steering CommitteeTHISGUIDELINE HAS BEEN DEVELOPED BY THE APPROPRIATEVICH EXPERTWORKINGGROUP AND HASBEEN SUBJECT TO CONSULTATION BY THE PARTIES,IN ACCORDANCE W ITH THEVICH THEPROCESS THE FINAL DRAFT IS RECOMMENDED FOR ADOPTION TO THE REGULATORY BODIES OFTHEEUROPEANUNION,JAPAN IMPLEMENTATION AT STEP 7 (FINAL) 06/00 Page 2 of 27 EMEA 2000 Good Clinical PracticeINTRODUCTIONThe objective of
properly conducted and whether the data are or were recorded, analyzed and accurately reported according to the study protocol, study related standard operating procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements. 1.4. Authenticated Copy A copy, which is a complete reflection of an original document, that ...
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