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VICH Topic GL9 (GCP) - Europa

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)

A procedure to reduce potential study bias in which designated study personnel are kept uninformed of the treatment assignment(s). 1.6. Case Report Forms/Data Capture Forms/Record Sheets Printed, optical, electronic, or magnetic documents specifically designed to record study protocol-required and other observations of study animals or

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