Loryn Thorburn
© 2010 PAREXEL International | Confidential

• 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

Introduction to the CDASH Guide:
Section 2 – CDASH Alignment with Other Standards
• 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 3 – Best Practice Recommendations
• 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 4 – Overview of CDASH Domain Tables
• 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
• 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

Section 5 – CDASH Domain Tables
Domain Name
Common Identifier Variables
Common Timing Variables
Comments – CO
Domain Name
Exposure – EX
Inclusion/Exclusion Criteria Not Met – IE
Laboratory Test Results – LB
Adverse Events - AE Medical History – MH
Prior and Concomitant Medications – CM Physical Examinations – PE
Demographics – DM
Disposition – DS
Protocol Deviations – DV
Subject Characteristics – SC
Drug Accountability – DA
ECG Test Results – EG
Substance Use – SU
Vital Signs - VS

Introduction to the CDASH Guide:
Sections 6 and 7
• 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