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November 2007
Reflection Paper on Expectations for Electronic Source Documents Used in Clinical Trials (EMEA GCP Inspectors Working Group).






May 2007
Guidance for Industry: Computerized Systems Used in Clinical Investigations.






undated
Risk-Based Approach to 21 CFR Part 11.






May 2005
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.






November 2006
Leveraging the CDISC Standards to Facilitate the use of Electronic Source within Clinical Trials (Final).






September 2005
Leveraging the CDISC Standards to Facilitate the use of Electronic Source within Clinical Trials (Draft).






August 2003
Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application.






February 2003
Draft Guidance for Industry on 'Part 11, Electronic Records, Electronic Signatures - Scope and Application.






January 2002
General Principles of Software Validation; Final Guidance for Industry and FDA Staff.






November 2000
Legal Considerations in Designing and Implementing Electronic Processes: A Guide for Federal Agencies.






October 2000
Records Management Guidance for Agencies Implementing Electronic Signature Technologies.






September 1999
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software use in Medical Devices.






April 1999
Guidance for Industry: Computerized Systems Used in Clinical Trials.






March 1997
Electronic Records; Electronic Signatures; Final Rule.







10 June 2008
Fida Dankar, a post-doctoral fellow at the Electronic Health Information Laboratory will be presenting a modified k-Anonymity procedure in a talk entitled "Protecting Privacy Using k-Anonymity" on June 18, 2008 at 4:00 p.m. at the University of Ottawa, room CBY-A707.




19 February 2008
The fourth annual Electronic Health Information and Privacy conference will be held on 3rd November 2008 at the Hampton Inn Conference Center, Ottawa. This year's main themes will be the privacy of geographic/location information, and genetic data privacy.




14 December 2007
The full set of presentations from the Electronic Health Information and Privacy Conference held in Ottawa on 3 December is now available. The conference covered a wide spectrum of policy, technical, and ethical issues related to the collection, use, and disclosure of clinical and genetic information, including EHR governance issues, medical ID theft, and public attitudes and behaviors towards privacy.



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This page last modified on:
Tue Aug 19 2008