Page History

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• Annotated sample case report forms (CRFs) compliant with CDASH

• CDASH metadata associated with the sample CRFs

• Guidance on the use of CDASH and SDTM variables

• Guidance on which domain models and datasets from the SDTM Implementation Guide for Human Clinical Trials (SDTMIG) to use in storing raw/collected data

• Examples of SDTM datasets, with text describing the situational context and pointing out records of note

• Cross-implementation variable definition metadata for non-standard (supplemental) variables used in example SDTM datasets and/or CRF mapping annotations

• Analysis datasets compliant with ADaM, with dataset- and variable-level metadata

• Table shells, mock reports, and diagrams illustrating the kinds of statistical analysis that can be performed based on the ADaM datasets

• Biomedical concept metadata exported from the Shared Health And Research Electronic (SHARE) metadata repository

A TA standard may also include:

describe common kinds of data needed for area studies, so that those handling the data (e.g., data managers, statisticians, programmers) understand the data and can apply standards appropriately. These descriptions sometimes include the clinical situations from which the data arise, and the reasons the data are relevant to the TA.

A TA standard strives to define biomedical concepts unambiguously, so that consistent terminology can be used in area studies to enable aggregation and comparison of data across studies and drug programs, and so that metadata for these biomedical concepts can be likewise defined.

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Does not include

•  Advice on what data to collect or how to analyze it
•  Information and advice already included in the foundational standards
•  Definitive controlled terminology (see the NCI-EVS website for the latest CT)
•  Implementation advice and terminology for questionnaires, ratings, and scales
•  Regulatory guidance or advice (though it includes some relevant references)
•  Clinical advice (though it includes some relevant references)

Does include

•  Advice on how to represent data using CDISC standards (but not those well covered in foundational standards – see above)
•  Examples illustrating this advice
•  Explanations for why the standards were implemented as shown in the examples, including clinical background relevant to modeling decisions
•  As part of those explanations, diagrams (concept maps) that illustrate clinical processes and/or relationships among data items
•  Where applicable, links to proposed additions to the standards (e.g., proposed new domains or variables) used in the examples
•  Links to Biomedical Concepts for some core TA data (these are maintained in SHARE, which is the authoritative source)

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