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Workshop Slated on Clinical Investigation Quality

04/30/2007

Federal Register Notice: FDA will co-sponsor a public workshop 5/10-11 with the Drug Information Association entitled “Defining and Implementing Quality in Clinical Investigations: From Design to Completion.'' FDA and DIA aim to solicit information on identifying attributes of quality in clinical investigations, approaches to quality from design to completion, and methods for measuring quality and ensuring data integrity during the conduct of clinical investigations. The workshop will discuss the definition of quality, mechanisms for implementing quality in clinical investigations, and methods to improve the accuracy and reliability of collected data, which will enhance human subject protection. It will take place from 8 a.m. to 5 p.m. at the Washington Marriott Hotel, 1221 22nd St. NW., Washington, DC 20037. Contact Kathleen Donner, DIA, (215) 293-5810. To view this notice, click here.

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