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

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Presentation on theme: "An Introduction to Clinical Data Acquisition Standards Harmonization (CDASH) Loryn Thorburn © 2010 PAREXEL International | Confidential."— Presentation transcript:

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

2 22 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: Purpose

3 33 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

4 44 CDASH defines data collection SDTM defines data submission formats CDASH data collection fields facilitate mapping to SDTM structure of SDTM IG version 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

5 55 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

6 66 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

7 77 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

8 88 Domain Name Common Identifier VariablesExposure – EX Common Timing VariablesInclusion/Exclusion Criteria Not Met – IE Comments – COLaboratory Test Results – LB Adverse Events - AEMedical History – MH Prior and Concomitant Medications – CMPhysical Examinations – PE Demographics – DMProtocol Deviations – DV Disposition – DSSubject Characteristics – SC Drug Accountability – DASubstance Use – SU ECG Test Results – EGVital Signs - VS Introduction to the CDASH Guide: Section 5 – CDASH Domain Tables

9 99 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

10 10 Questions


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