From: Robinson, Connie [connie_robinson@merck.com] Sent: Thursday, December 16, 2004 2:56 PM To: 'fdadocket@oc.fda.gov'; Mayhew, Brian M. Subject: Docket 04D-0440 Draft Guidance for Industry; Computerized Systems Used in Clinical Trials Attached are the comments of Merck Research Laboratories on Docket 04D-0440 Draft Guidance for Industry; Computerized Systems Used in Clinical Trials <<04D-0440 Comment ltr re Computerized Systems121304.pdf>> <<04D-0440 Comment ltr re Computerized Systems.doc>> We have provided a pdf file with the signed Merck comments letter. Due to the size of this document, a word version will be send separately for your convenience. Please confirm receipt of these comments, and let us know if there is any difficulty with the files. ------------------------------------------------------------------------------ Notice: This e-mail message, together with any attachments, contains information of Merck & Co., Inc. (One Merck Drive, Whitehouse Station, New Jersey, USA 08889), and/or its affiliates (which may be known outside the United States as Merck Frosst, Merck Sharp & Dohme or MSD and in Japan, as Banyu) that may be confidential, proprietary copyrighted and/or legally privileged. It is intended solely for the use of the individual or entity named on this message. If you are not the intended recipient, and have received this message in error, please notify us immediately by reply e-mail and then delete it from your system. ------------------------------------------------------------------------------