Hướng dẫn sử dụng CDASH và CDISC

CDASH MODEL 1.0 AND CDASHIG 2.0

Kathleen Mellars
Special Thanks to the CDASH Model and CDASHIG Teams

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© CDISC 2016


What is CDASH?
• Clinical Data Acquisition Standards Harmonization
(CDASH)
• Standards for the collection of clinical trial data, and
the implement of the standard in case report forms
• It has 3 components
– The CDASH Model
– The CDASH Implementation Guide (CDASHIG)
– CDASH Domain Metadata Table

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© CDISC 2016


What is CDASH ?
• Goal is to reduce unnecessary variability between CRFs,
and to encourage the consistent use of variables to
support semantic interoperability
• Intended to facilitate mapping and end-to-end
traceability to the SDTM-based data structure
• Used by persons involved in the planning, collection,
management and analysis of clinical trials and clinical

data
– including Clinical Investigators, Medical Monitors, Clinical Research
Associates (Monitors), Clinical Research Study Coordinators, Clinical Data
Standards Subject Matter Experts (SME), Clinical Data Managers, Clinical
Data and Statistical Programmers, Biostatisticians, Drug Safety, Case
Report Form (CRF) Designers

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© CDISC 2016


CDASH Conformance Rules
1. CDASH Core designations must be followed
– Highly Recommended (HR): A data collection field that should always be on
the CRF (e.g., the data are needed to meet a regulatory requirement, or the
minimum data that are needed for a meaningful dataset).

– Recommended/Conditional (R/C): A data collection field that should be on
a CRF based on certain conditions (e.g., complete date of birth is preferred, but
may not be allowed in some regions; AE time should only be captured if there is
another data point with which to compare it). For any
recommended/conditional fields, the "condition" is described in the
"Implementation Notes" portion of the metadata table.

– Optional (O): A data collection field that is available for use.

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© CDISC 2016

CDASH Conformance Rules-Cont
2. CDISC Controlled Terminology must be used
– All codelists displayed in the CRF must use or directly map to the current
published CDISC Controlled Terminology submission values, when it is available.
• Example: SEX may be displayed as "Male" or "Female" while, the controlled
terminology values of "M" and "F" would be used in the SDTM-based datasets.

3. CDASH Best Practices must be followed
– CRF follow Best Practices for Creating Data Collection Instruments and CRF
Design Best Practices

4. CDASH Question Text or Prompt must be used to ask the
question
– A familiar synonym on the CRF may be used without affecting conformance.
– Translation must be semantically consistent with the CDASH Question Text and
Prompt
– When more specific question text is needed, CDASH recommends the use of a
brief CRF Completion Instruction,
•

Instruction must only clarify the data required by the study without altering the
meaning as defined by the standard.
– For example "Sex at birth" is not the same question as "Sex" (which is loosely
defined as "reported sex").
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© CDISC 2016


CDASH Conformance-Cont
5. Variable Names have end-to-end traceability

– From data capture system to SDTM-based datasets
– Supports automating electronic data capture (EDC) setup and downstream
processes

6. Data Values and Format
– Data outputted by the operational database into an SDTMIG variable ideally
requires only minimal processing (e.g., changing case)

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© CDISC 2016


CDASH – What’s new?
• Almost everything!
– New CDASH Model v.1.0 introduced
– CDASH Standard v1.1 and CDASH User Guide v.1.0 were
consolidated to create CDASHIG v2.0
– CDASH documents stored on the CDISC WIKI
– CDASH Model and Domain metadata can be downloaded
as Excel spreadsheet
ã ability to include in SHARE

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â CDISC 2016


Accessing the CDASH Guides
Available at CDASH Wiki:
/>
© CDISC 2016

Relationships between SDTM and CDASH
• CDASH Model 1.0 aligns with SDTM Model 1.4
• CDASHIG 2.0 aligns with SDTMIG 3.2
CDASH Model 1.0

CDASHIG 2.0

SDTM Model v1.4

SDTMIG 3.2

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© CDISC 2016


CDASH Model 1.0
• Defines a framework for creating standard variables
used in the collection of clinical trial data
• Provides variable naming conventions (e.g., root
variable names --xxxx)
• Includes metadata for
–
–
–
–

Identifier variables, and Timing variables
Special Purpose Domains (e.g., DM, CO)

SDTM General Observation Classes (Events, Interventions, Findings)
Domain-specific variables

• Includes generic “parameterized” Question Text and
Prompt- for flexible implementation (e.g., verb tense,
sponsor defined time periods)
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© CDISC 2016


CDASH Model Metadata builds in traceability to SDTM Model
and CDASHIG conformance
Special Purpose
(e.g.. DM)

Interventions

Events

Findings

â CDISC 2016

ã

The key attributes
needed for CDASHIG
conformance are
included in the CDASH
Model

•
•
•
•

Root variable name (e.g., -TRT)
Definition
Mapping to SDTM
Generic Question Text /
Prompt
Controlled Terminology


CDASH Model – Excerpt from Events

© CDISC 2016


CDASH Implementation Guide (CDASHIG) 2.0
• Aligns with SDTMIG
– Domains are organized by Class
– General Assumptions per Class
– General Assumptions per Domain

• CDASH Domain metadata for SDTMIG domains
based on the CDASH Model
• aCRF examples for each domain, unless
otherwise specified
– Example which are not meant to imply that any particular layout is preferable

over another
– Annotated to show SDTM mapping.

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© CDISC 2016


CDASHIG 2.0 Domains
Each CDASHIG Domain, unless otherwise specified, has:
• Description/Overview

• Specifications defined in the CDASH Domain Metadata
Spreadsheet
• Domain Level Assumptions
– Annotated Example CRFs

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© CDISC 2016


Excerpt from Domain Metadata Table

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© CDISC 2016


CDASHIG 2.0 Example CRF

The CDASH/SDTM Target
variables are identical.

The CDASH variable is mapped to the
SDTM Target variable.

This CDASH variable is not
submitted.

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© CDISC 2016


CDASH: Future
• Include missing SDTMIG domains into future
version of the CDASHIG.
• Pilot using CDASH Domain Metadata to
create CDASH CRF specific metadata.
ã Auto-generating CDASH CRFs from the CRF
metadata.

â CDISC 2016

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