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FDA releases clinical trials guidance draft

EHR Connection, October 11, 2004

The FDA released draft clinical trials guidance for comment about creating and maintaining computerized systems-attempting to integrate with electronic signature policy passed last year, according to Health Data Management (HDM).

The FDA recommends nine general principles including:

  • making data accessible and accurate
  • implementing security measures
  • developing computerized systems compliant with regulatory requirements
Comments will be accepted until January 3, 2005, reports HDM.

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