Transcription of REFLECTION PAPER ON EXPECTATIONS FOR …
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REFLECTION PAPER ON EXPECTATIONS FOR …
European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) E-mail: EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London, 17 October 2007 Doc. Ref. EMEA/505620/2007 GCP INSPECTORS WORKING GROUP <DRAFT> REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN clinical TRIALS ADOPTION BY GCP INSPECTORS WORKING GROUP FOR RELEASE FOR CONSULTATION 14 June 2007 END OF CONSULTATION (DEADLINE FOR COMMENTS) 31 April 2008 ADOPTION BY GCP INSPECTORS WORKING GROUP <day month year> DATE FOR COMING INTO EFFECT <day month year> Comments should be provided using this template to Fax +44 20 7418 8595 KEYWORDS Source data, electronic, eCRF, eSource, ePRO, clinical trial Page 2/10 EMEA 2007 REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN clinical TRIALS TABLE OF CONTENTS EXECUTIVE 3 1.
Computers are being used increasingly in the conduct of clinical trials. This is already a well-established practice for data management, analysis and reporting at …
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