Study Data Tabulation Model.

Provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process. 

 Clinical Data Acquisition Standards Harmonization. 

Establishes a standard way to collect data consistently across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM).

Analysis Data Model. 

ADaM defines dataset and metadata standards that support: efficient generation, replication, and review of clinical trial statistical analyses, an traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).​

1. Refers to the comments received from the Check of Concepts and ensure issues were resolved appropriately.
2. Resolve gaps or discrepancies that exist and prepare the draft standard and all other documents needed for the Internal Review.
3. Conducts a project review with the Modeling Experts, as needed.
4. Maintains a project decision tracker, so Project Teams have a central location to find this information. Checks outstanding issues, works toward resolution, and updates the tracker throughout the course of the project.

1. Defines the metadata modeling approach for new concepts
2. Determines what SDTM examples are needed for the standard. 
3. Determines what SDTM examples are needed for the standard. 
4. Determines what analysis, metadata, and ADaM dataset examples are needed for the TA User Guide.
5.  Builds on the initial gap analysis to determine if new metadata needs to be developed.

1. Completes the gap analysis on SDTM mappings
2. Ensures proposed standards are aligned with SDTM
3. Helps the Metadata Developer determine what examples are needed for the standard.

1. Coordinates developing CDASH Metadata
2. Coordinates with CDASH subteam to generate CDASH metadata and examples of therapeutic area research concepts.
3. Ensures proposed standards are aligned with the latest version of CDASH and the CDASH Model

1. Helps TA Statistical Programmer determine what examples are needed for the TA User Guide.

1. Identifies which statistical artifacts, and ADaM, if possible (dataset and analysis metadata) are needed to efficiently conduct specified analyses of statistical endpoints
2. Helps to construct statistical examples, and ADaM, if possible
3. Verifies compatibility with analysis objectives

1. Examine concepts and consider what specific content is needed as part of the final standards product. If any new domains or variables are needed, proposals are developed and shared with the appropriate CDISC foundational team. 

1. Maintains formatting and layout of the document
2. Generates and maintains the formal references list
3. Ensures permissions for graphs and text are acquired from copyright holders as appropriate
4. Maintains the CDISC TA User Guide Template
5. Builds the standard by incorporating content and examples as they are developed by the Metadata Developers and Concept Modelers

1. Functions as the Subject Matter Expert (SME) for therapeutic area concepts, clinical endpoints and terminology
2. Responsible for the medical content of TA User Guides by writing, and sometimes reviewing sections of data standards that require clinical expertise, with the Medical Writer
3. Reviews and assists in the search of medical literature and regulatory guidance to ensure appropriate references are included, cited and followed, as needed
4. Ensures examples in the TA guide are appropriate and clinically accurate, ensures the draft standard is understandable for the implementation community

1. Contributes and writes and reviews sections of TA standards document, as needed
2. Works with Technical Writer to improve and enhance existing templates and approaches

1. Copies the template sheet to a new sheet, fills in the concept-level metadata, deletes any concept variable rows that are not relevant for the concept
2. Populates or modifies Controlled Terminology and SDTM variable information as needed, and adds relevant information about associations with other concepts.

1. Approves the modeling before the standard may be posted for internal review.

Metadata Developer / SDTM Expert

Metadata Developer / CDASH Representative

TA Statistical Programmer

ADaM Expert

Clinical TA Expert / Medical Writer

Refers to the comments received from the Check of Concepts and ensure issues were resolved appropriately.