Hướng dẫn sử dụng CDASH và CDISC

• 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 comp

CDASH MODEL 1.0 AND CDASHIG 2.0

Kathleen Mellars

Special Thanks to the CDASH Model and CDASHIG Teams

1

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)

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

3

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

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") 5

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)

CDASH – What’s new?

• Almost everything !

– CDASH Standard v1.1 and CDASH User Guide v.1.0 were

– CDASH documents stored on the CDISC WIKI

– CDASH Model and Domain metadata can be downloaded

as Excel spreadsheet

• ability to include in SHARE

7

Accessing the CDASH Guides

Available at CDASH Wiki:

http://wiki.cdisc.org/display/CMIG/CDASH+Model+and+CDASHIG

Relationships between SDTM and CDASH

• CDASH Model 1.0 aligns with SDTM Model 1.4

• CDASHIG 2.0 aligns with SDTMIG 3.2

9

SDTM Model v1.4

SDTMIG 3.2 CDASHIG 2.0

CDASH Model 1.0

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

CDASH Model Metadata builds in traceability to SDTM Model

and CDASHIG conformance

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

Interventions

Special Purpose

(e.g DM)

Findings

Events

• 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

13

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

Excerpt from Domain Metadata Table

15

CDASHIG 2.0 Example CRF

The CDASH/SDTM Target variables are identical

The CDASH variable is mapped to the SDTM Target variable

CDASH: Future

• Include missing SDTMIG domains into future

version of the CDASHIG

• Pilot using CDASH Domain Metadata to

create CDASH CRF specific metadata

• Auto-generating CDASH CRFs from the CRF

metadata