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 © 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 components – The CDASH Model – The CDASH Implementation Guide (CDASHIG) – CDASH Domain Metadata Table â CDISC 2016 What is CDASH ? ã 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 © CDISC 2016 CDASH Conformance Rules 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 © CDISC 2016 CDASH Conformance Rules-Cont 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 CDASH Best Practices must be followed – CRF follow Best Practices for Creating Data Collection Instruments and CRF Design Best Practices 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") © CDISC 2016 CDASH Conformance-Cont 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 Data Values and Format – Data outputted by the operational database into an SDTMIG variable ideally requires only minimal processing (e.g., changing case) © 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 • ability to include in SHARE © CDISC 2016 Accessing the CDASH Guides Available at CDASH Wiki: http://wiki.cdisc.org/display/CMIG/CDASH+Model+and+CDASHIG © 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 © 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) 10 © 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 13 © 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 14 © CDISC 2016 Excerpt from Domain Metadata Table 15 © 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 16 © 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 • Auto-generating CDASH CRFs from the CRF metadata © CDISC 2016 17 ... http://wiki .cdisc. org/display/CMIG /CDASH+ Model+and+CDASHIG © 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. .. case) © 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. .. case report forms • It has components – The CDASH Model – The CDASH Implementation Guide (CDASHIG) – CDASH Domain Metadata Table © CDISC 2016 What is CDASH ? • Goal is to reduce unnecessary variability