CDISC( Clinical Data Interchange Standards Consortium ) Milestones
To develop and support global ,platform-independent data standards that enable information system interoperatability to improve medical research and related areas of HC
- Founded around 1997
- Summer 1998 invited to form DIA SIAC
- Feb2000- Formed an idependent non-profitable oraganization
- Dec 2001-Global Presenation
To develop and support global ,platform-independent data standards that enable information system interoperatability to improve medical research and related areas of HC
What is SDTM ?
Standard Data Tabulation Model describes the general abstract model for representing clinical study data that is submitted to regulatory agencies .The CDISC standards provides standard descriptions of the most commonly used domains , with meta attributes .On July 2004 SDTM was selected as a standard specification for submitting tabulation data to FDA
The General Observation Classes
The CDISC has classified the domain in to four different categories : Interventions, Events, Findings and Others .
Interventions
Are related to the therapeutic and experimental treatments
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