Introduction
Versions
An Analysis Data Model Implementation Guide (ADaMIG) is developed in reference to a specific ADaM model. Currently, all ADaMIGs are supported by the ADaM v2.1 model. Additional ADaM supplements containing normative content for specific analysis use cases have also been developed. The table below lists the documents available at the time of publication of ADaMIG v1.3 and describes their applicability to ADaMIG Versions 1.0, 1.1, 1.2, and 1.3.
In addition to Models and Implementation Guides, Conformance Rules have been developed, which help to ensure that generated data structures conform to the standards. These rules aim to identify all conformance rules and case logic from ADaM documents, classifying and codifying them in a form that supports quality processes and tool development.
Therapeutic Area User Guides
Therapeutic Area User Guides (TAUGs) extend the Foundational Standards to represent data that pertains to specific disease areas. TAUGs include disease-specific metadata, examples and guidance on implementing CDISC standards for a variety of uses, including global regulatory submissions. The following video will introduce you to TAUGs and how they relate to CDISC Foundational Standards.
Controlled Terminology
Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. The following video introduces you to CDISC Controlled Terminology and how it is used with CDISC standards.
Traceability
Traceability is a fundamental element of data quality and a requirement for studies submitted to regulatory authorities. From data collection to final analysis, traceability plays a crucial role in ensuring the integrity of source data and in reinforcing clinical research results. The following video provides an introduction to implementing traceability in CDISC-compliant studies.
Regulatory Requirements
CDISC standards are required or recommended by several global regulatory agencies. Standardized data enables regulators to streamline the review process with a more consistent use of analysis tools to better view drug data and highlight areas of concern. The following video introduces you to regulatory requirements and the use of CDISC standards.
Team Guiding Principles
Standards in Development
Foundational
For current versions of the standards, please visit the Standards Home Page.
| Standard Sort descending | Release Notes | Projected Publication |
|---|---|---|
| ADaM Oncology Examples | Resolving Public Review Comments |
2024 |
| ADaM v3.0 | In Development |
2026 |
| CT Relationships for SDTM v1.7, SDTMIG v3.3, SDTMIG-MD v1.1 | Resolving Public Review Comments |
2024 |
| SDTM v2.2 | In Development |
2025 |
| SDTMIG v4.0 | In Development |
2025 |
| SENDIG v4.0 | In Development |
2025 |
Data Exchange
Therapeutic Areas
For current versions of the Therapeutic Area (TA) standards, please visit the TA Home Page.
| Therapeutic Area Sort descending | Release Notes | Projected Publication |
|---|---|---|
| Duchenne Muscular Dystrophy Therapeutic Area User Guide v1.0 | Version 1.0 of the Duchenne Muscular Dystrophy Therapeutic Area User Guide (TAUG-DMD) was developed under the CFAST Program and the CDISC Standards Development Process. The TAUG-DMD describes the most common biomedical concepts relevant to Duchenne Muscular Dystrophy, and the necessary metadata to represent such data consistently with Terminology and SDTM. TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints. Public Review Comments CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process. TA Specifications TA Specifications show how to modify TAUG examples for various versions of the SDTM and SDTMIG. These specifications assist the FDA and the Japanese PMDA with testing to enable support of the standards and inclusion in their respective Technical Conformance Guides.1,2 The specifications comprise five worksheets in an Excel workbook:
|
2024 |