U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
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Center for Drug Evaluation and Research |
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Impact of Regulations on
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Table of ContentsImpact of Regulations on Data Management Practice Part 11 Electronic Submissions What Submissions Are Currently Accepted in Electronic Format? What Electronic Submissions Are Being Considered? Electronic Submission Information Health Insurance Portability and Accountability Act (HIPAA) Standards Development Organizations Study Data Standards Initiatives Standard Descriptive Variables Observations Characterized Using Standard Descriptive Variables Study Data Standards Controlled Terminology Study Data Standards Data Content Standards |
Author: Randy Levin, M.D. Associate Director for Information Management Center for Drug Evaluation and Research U.S. Food and Drug Administration Home Page: http://www.fda.gov/cder/regulatory/ersr/default.htm |
FDA/Center for Drug Evaluation and Research
Last Updated: November 14, 2002
Originator: OTCOM/DLIS
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