Decoding the

Acronyms i n

C l i n i c a l

Data

Standards

Who is

BehindC l i n i c a l

D a t a

S t a n d a r d s ?

Bi omedi ca

l

Research

Integrated

Domain

Group

Col labora t ive e f f o r t among advocates f o r data s tandard iza t ion .

A Domain Analys is Model.

I t ' s goal i s t o standardize domains and s t ruc tu res f o r c l i n i c a l data.

C l i n i c a l

Data

I nt er change

Standards

Consortium

Non-p ro f i t o rgan iza t ion founded i n 1997.

Sponsored by 32 companies across the globe.

Works t o st reaml ine the submission of c l i n i c a l data t o the FDA.

Wor l d

Wide

Web

Consor t i um

" In te rna t iona l community t ha t develops open

standards" f o r data exchange across the web.

Provides an idea l framework f o r healthcare data

i n i t i a t i v e s .

Decodi ng The Acr onyms

Acr onym: SDTM

F u l l Name: Study Data Tabulat ion Model

Descr ip t ion:

CDISC standard f o r submi t t ing c l i n i c a l data to the FDA.

Groups data i n t o var iables, which can be grouped i n t o domains.

Acr onym: CDASH

F u l l Name: C l i n i c a l Data Acqu is i t i on

Standards Harmonization

Descr ip t ion:

Provides a content template f o r Case Report Forms (CRFs).

Provides co l l ec t i on data f o r 18 domains.

Acr onym: ADaM

F u l l Name: Analysis Data Model

Descr ip t ion:

Standardizes the d isp lay of data f o r analys is purposes.

Emphasizes p r i nc i p l es of data order and organizat ion.

Acr onym: SHARE

F u l l Name: Shared Health And Research

Elec t ron i c L i b r a r y

Descr ip t ion:

Global e lec t ron ic l i b r a r y f o r CDISC metadata standards.

Response to FDA pressure f o r a un ive rsa l metadata repos i tory.

Acr onym: RDF

F u l l Name: Resource Descr ip t ion

Framework

Descr ip t ion:

Aims to t rans la te Engl ish i n t o a programming language.

Helps show re la t i onsh ips amongst var iab les.

Acr onym: OWL

F u l l Name: Web Ontology Language

Descr ip t ion:

B u i l t i n s i d e the RDF.

Allows add i t i ona l c l as s i f i ca t i on & descr ip t ion in format ion .

Acr onym: SKOS

F u l l Name: Simple Knowledge

Organizat ion System

Descr ip t ion:

RDF-Based.

Vocabulary f o r creat ing terminologies.

Aboutd-Wised-Wise works w i t h l i f e science and heal thcare organ iza t ions t o solve t h e i r

business op t im iza t i on challenges.

d-Wise’s ten-year h i s t o r y o f t a i l o r i n g so lu t i ons t o meet i n d i v i d u a l c l i e n t needs

and d e l i v e r data i n t e g ra t i o n , data warehousing and standards so lu t i ons w i t h i n

h i gh l y - regu la ted i n d u s t r i e s i s rooted i n extensive domain knowledge o f SAS

software, c l i n i c a l drug development and c l i n i c a l data standards l i k e CDISC.

Our so lu t i ons f o r c l i n i c a l t r i a l op t im iza t ion , metadata management, and c l i n i c a l

standards prov ide a s o l i d foundat ion f o r e x t r a c t i n g accurate business ana l y t i cs ,

enabl ing c r i t i c a l business decis ions t o be made r a p i d l y and based on a l l the data.

W i t h i n the heal thcare arena, d-Wise provides data op t im iza t i on f o r a c t u a r i a l ,

q u a l i t y, medical-management, and opera t iona l data marts and warehouses, as we l l

as support f o r f raud detec t ion us ing d a t a - d r i v e n and repeatable processes.