Clinical Data Interchange Standards Consortium

Clinical Data Interchange Standards Consortium (CDISC)... 

The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit group that defines clinical data standards for the pharmaceutical industry. CDISC has developed numerous data models that you should familiarize yourself with. Four of these models are of particular importance to you ... 

The Clinical Data Interchange Standards Consortium (CDISC) and its Submission Data Standards group have provided another way to broadly categorize clinical trial data. 

Public Meeting on Clinical Data Interchange Standard Consortium Version 3 Submission Data Standards and Electronic Case Report Tabulations, October 2, 2003, Rockville, MD (Posted October 7, 2003)... 

Currently, most INDs are submitted in paper form, often accompanied by an electronic disk with hyperlinks. Purely electronic submissions are still rare, in large part because of a lack of standardization and electronic sophistication on the part of the FDA. There is currently a Clinical Data Interchange Standards Consortium (CDISC) test underway assuming it proves successful, it is likely that CD ISC will emerge as a common electronic submission standard for INDs, New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs) over the next three to five years. 

The type of data standards that will be implemented should be stated. For example, datasets will be created using Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards (as specified by the Clinical Data Interchange Standards Consortium at http //... 

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