An Introduction to Clinical Data Acquisition Standards Harmonization

(CDASH)

Loryn Thorburn

© 2010 PAREXEL International | Confidential

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• CDASH defines basic standards for collection of clinical trial data

• Forms part of Clinical Data Interchange Standards Consortium (CDISC)

• CDISC designed to harmonize standards for the collection and submission of data from clinical trials

• CDASH Standard Version 1.1

• Released 18 January 2011

• Download guide at: http://www.cdisc.org/cdash

Purpose

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• Provides the introduction and explains the scope of the guide

• Defines conformance at an individual CRF level

Introduction to the CDASH Guide:Section 1 - Orientation

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• CDASH defines data collection

• SDTM defines data submission formats

• CDASH data collection fields facilitate mapping to SDTM structure of SDTM IG version 3.1.2

• Definition of Controlled Terminology: A finite set of values that represent the only allowed values for a data item

• CDISC controlled terminology is terminology applicable to CDASH data collection fields

Introduction to the CDASH Guide:Section 2 – CDASH Alignment with Other Standards

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• Lists a number of recommended methodologies with rationale for creating data collection instruments. Example: Review of CRF – who and why

• Provides a suggested CRF development workflow diagram

• Has a number of examples of FAQs with best practice recommendations and rationale. Example: ‘9. Should data be prepopulated in the CRF?’

Introduction to the CDASH Guide:Section 3 – Best Practice Recommendations

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• The Domains contain the most commonly used fields

• Additional therapeutic area data collection points may be added as required

• CRF layout not within the scope of CDASH however, the data fields are listed in the order they commonly occur in the CRF

• Data fields classified as the following: Highly recommended – field should be on the CRF

Recommended/Conditional – field should be present but based on certain conditions, e.g. complete data of birth is not allowed in some regions

Optional

Introduction to the CDASH Guide:Section 4 – Overview of CDASH Domain Tables

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• Domain tables have the following headers: Question text – full question text for data field

Prompt – field short prompt/label

SDTM or CDASH variable name

BRIDG – contains the BRIDG classification

Definition – describes purpose of the field

CRF Completion Instructions – instruction for clinical site on how to enter data into CRF

Information for Sponsors – additional information including rationale and implementation instructions

Core – contains field core designation

• Instructions for using a denormalized structure

Introduction to the CDASH Guide:Section 4 – Overview of CDASH Domain Tables

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Domain Name Domain Name

Common Identifier Variables Exposure – EXCommon Timing Variables Inclusion/Exclusion Criteria Not Met – IEComments – CO Laboratory Test Results – LB

Adverse Events - AE Medical History – MH

Prior and Concomitant Medications – CM Physical Examinations – PE

Demographics – DM Protocol Deviations – DV

Disposition – DS Subject Characteristics – SC

Drug Accountability – DA Substance Use – SU

ECG Test Results – EG Vital Signs - VS

Introduction to the CDASH Guide:Section 5 – CDASH Domain Tables

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• Section 6 - Change Control and the Process for Creating New CDASH Domains Briefly describes how changes are made to the guide

• Section 7 - Appendices Additional information including all commonly used

CDISC controlled terminology

Introduction to the CDASH Guide:Sections 6 and 7

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Questions