Module 12 Presentations

26/01/2024

CDISC : The Clinical Data Interchange Standards Consortium • CDISC develops global standards and innovations to streamline medical research and ensure a link with healthcare • CDISC Standard:  Defines a standard structure for human clinical trial and non-clinical study data tabulations  For example: SDTM (Study Data Tabulation Model) and SEND (Standard Exchange for Nonclinical Data) http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/de fault.htm

The Organisation for Professionals in Regulatory Affairs

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Evolution of CDISC Standards

Data Sources

Submission Data •CRT/Domain Datasets •Analysis Datasets •Metadata

Operational Database

Operational Data Interchange & Archive: ODM, LAB

Submission Data: SDS, ADaM, SEND, Protocol Representation

• Site CRFs •Laboratories

•Contract Research

•Study Data •Audit Trail •Metadata

Organizations •Development Partners

Standards for the Exchange of Non-Clinical Data (SEND) •Based upon SDTM •Implementation Guide •Pilot in progress

Submission Data Tabulation Model (SDTM) •Production Version 1.1

Operational Data Model (ODM) •Production Version 1.2 •XML schema •Define.xml specification

•Referenced as specification in FDA Guidance 21 July 04

Analysis Dataset Models (ADaM) •Analysis Models •General Considerations Document

Protocol Representation Model •Defined Protocol

Laboratory Data Model (LAB) •Production Version 1.0.1 •Implementations through SAS, ASCII, XML/ODM, and HL7 V3 RIM message

elements, documenta tion; initial HL7 model

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