Table of Contents
Regulated Clinical Research Information Management: Progress in Standards Development
Overview
Health Level Seven
RCRIM
FDA Data Council
Consolidate Health Informatics
ICH
Proposed Standards
Clinical Study Data
CDISC Version 3 Submission Data Model
Standard Descriptive Variables
Observations Characterized Using Standard Descriptive Variables
Annotated ECG Waveform Data
Stability Data
Electronic MedWatch
Structured Product Labeling
Unique Ingredient Identifiers
Other Standards
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Author: LEVINR
Home Page: http://www.fda.gov/cder/regulatory/ersr/DIA2003.htm
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