Module 12 Presentations

26/01/2024

CDISC Standards as part of the Clinical Data Flow

Figure 3: Data Flow Using CDISC

= ODM (transport)

= SDTM and Analysis Data (content)

= Protocol information (content)

= Source data (other than SDTM/CRF data)

Integrated Reports

Protocol Representation

Patient Info

Administrative, Tracking, Lab Acquisition Info

SDTM Data, Analysis Data, Metadata

Clinical (CRF or eCRF) Trial Data (defined by SDTM)

Trial Design (SDTM) Analysis Plan

ODM XML

ODM XML

ODM XML Define.xml

CRF, Analysis Data

Regulatory Submissions

Clinical Trial Protocol

(e)Source Document

Operational & Analysis Databases

The Organisation for Professionals in Regulatory Affairs .

11

CDISC Standards: End to End Process for Clinical Trials

Lab

Data Capture

Analysis Reporting

• PRM

•SDTM •ADaM •SEND Submission

•CDASH

•ADaM

•SDTM

Protocol

Data Storage

• TMF

Controlled Terminology

Documents

NP0

The Organisation for Professionals in Regulatory Affairs

12

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