Transcription of Good Clinical Data Management Practices
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Good Clinical Data Management Practices
Good ClinicaData ManagemPractices Comml ent ittee S C D MS C D MS C D MS C D M Good Clinical Data Management Practices Version 4 October 2005 Copyright 2003. Society for Clinical Data Management , Inc. All Rights Reserved The need for Good Clinical Data Management Practices is not new. In the early 1970s, the Public Health Service recognized this need through a contract to a major research university for training of Research Data Managers; however, the need continues, the need changes over time, and the need for good Clinical data Management Practices has become even more important as biopharmaceutical and medical device industry and regulatory bodies rely more and more heavily on the evaluation of electronically transmitted Clinical trials data for critical data-based decision making.
limited to the following: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems, file transfers or central web based systems. The ICH guidelines on Good Clinical Practice (GCP) use the term ‘case report form’ or ‘CRF’ to refer to these systems1. No ...
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