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Beyond the SDTMIG: The Hidden World of CDISC Guidance

Navigating the Maze of TAUGs, APs, MDs, and More

🌟 Hey, friends! 🌟

Welcome to this week’s episode of Dr. Clinidata! I hope your week was epic! 🚀

Oh, you've memorized the SDTM Implementation Guide? Congratulations! You've mastered the art of painting by numbers! Now, brace yourself for the Jackson Pollock world of CDISC guidance, where your neat little SDTMIG coloring book gets splattered with a rainbow of TAUGs, APs, MDs, and QRSs. Welcome to the big leagues, where "just following the SDTMIG" is like bringing a spoon to a knife fight.

Therapeutic Area User Guides (TAUGs):

  • TAUGs are developed to address specific data needs in various therapeutic areas like oncology, cardiovascular diseases, and diabetes.

  • They fill gaps in the SDTM Implementation Guide by providing detailed guidance on handling data unique to these areas.

  • TAUGs often introduce new variables and domains before they are officially added to the SDTM Model.

  • These guides are considered 'Provisional,' and their content is 'informative' rather than 'normative'.

  • When using a TAUG, it should be listed in the Trial Summary (TS) domain.

  • The FDA evaluates and supports specific TAUGs, which are listed in their Technical Conformance Guide.

  • It's crucial to cross-reference TAUGs with this guide to ensure regulatory compliance.

SDTM Implementation Guide for Associated Persons (SDTMIG-AP):

  • This guide focuses on modeling data about individuals who are not direct study participants, such as family members or caregivers.

  • It introduces the 'AP' prefix for domains (e.g., APMH for Associated Persons Medical History).

  • While the structure is similar to standard SDTM domains, it includes specific identifiers like APID, RSUBJID, and SREL and omits USUBJID.

  • The SDTMIG-AP is considered standard content and an extension of the main SDTMIG.

SDTM Implementation Guide for Medical Devices (SDTMIG-MD):

  • This guide provides standards for representing data related to any medical device used in a study, whether it's the focus of the study or not.

  • It defines seven device-specific domains: Device Identifiers (DI), Device-In-Use (DU), Device Exposure (DX), Device Events (DE), Device Tracking and Disposition (DT), Device-Subject Relationships (DR), and Device Properties (DO).

  • The current version (1.1) supersedes the previous version and is considered standard content extending the SDTMIG.

Questionnaires, Ratings, and Scales (QRS) Supplements:

  • These supplements offer guidance for mapping specific instruments to the Questionnaires (QS), Functional Tests (FT), or Clinical Classifications and Disease Response (RS) domains.

  • They cover instruments that are either in the public domain or copyright-approved.

  • QRS supplements undergo both Internal and Public Review before publication, similar to TAUGs.

  • They are considered extensions of the SDTMIG standards and are particularly useful for structuring instrument data properly in SDTM.

Define-XML standards:

  • The define.xml file is a critical component of SDTM submissions, providing metadata about the datasets.

  • CDISC publishes standards for Define-XML, with versions 2.0 and 2.1 currently accepted by the FDA.

  • These standards outline the structure and content requirements for the define.xml file, ensuring consistency and completeness in dataset documentation.

SDTM Metadata Submission Guidelines (MSG):

  • The MSG provides comprehensive guidance on preparing the various components required for a submission.

  • This includes the Annotated Case Report Form (aCRF), SAS v5 XPT files, define.xml, and the Clinical Study Data Reviewer's Guide (cSDRG).

  • While the information in this document is considered informative rather than normative, it's a valuable resource for ensuring all submission components are prepared correctly and consistently.

These guidelines collectively form a comprehensive framework for creating SDTM datasets that are not only technically correct but also aligned with regulatory expectations and consistent across different studies and sponsors. They address various aspects of clinical trial data, from specific therapeutic areas to associated persons and medical devices, as well as the metadata and documentation required for submissions. By following these guidelines, data preparers can ensure their SDTM datasets meet both CDISC standards and regulatory requirements, facilitating more efficient review processes and cross-study analyses by regulatory agencies.

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