Regulatory News In Brief

Part 11: FDA plans to publish draft guidance on use of computerized systems in clinical trials by the end of August. The "Part 11" draft guidance will replace a guidance on the same topic published in April 1999 and align the guidelines with policy articulated in FDA's broader guidance released in August 2003: "Part 11, Electronic Records; Electronic Signatures - Scope and Application" (1"The Gray Sheet" Sept. 8, 2003, In Brief). The forthcoming draft guidance is expected to outline general principles that should be followed when computerized systems are used to create, modify, maintain, archive, retrieve or transmit clinical trial data to ensure that electronic records meet regulatory standards and requirements. Many of the guidance's general principles are expected to address clinical trial electronic record security...