1. An Introduction to Clinical Data Acquisition Standards Harmonization (CDASH)
Loryn Thorburn
© 2010 PAREXEL International | Confidential

2. Purpose
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
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3. Introduction to the CDASH Guide: Section 1 - Orientation
Provides the introduction and explains the scope of the guide
Defines conformance at an individual CRF level

4. CDASH defines data collection SDTM defines data submission formats
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

5. Provides a suggested CRF development workflow diagram
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?’

6. The Domains contain the most commonly used fields
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

7. Domain tables have the following headers:
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

8. Introduction to the CDASH Guide: Section 5 – CDASH Domain Tables
Domain Name
Common Identifier Variables
Exposure – EX
Common Timing Variables
Inclusion/Exclusion Criteria Not Met – IE
Comments – 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

9. 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

10. Questions