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. Leads one or more TA projects
2. Manages projects by coordinating sub-teams, schedules and deliverables according to the 10-12 month development timeline
3. Ensures effective team interactions and overall project communication
4. Collaborates with Education Representative to develop TA education materials, or assigns a TA team member, and coordinates team review of draft and final training materials
5. Refers to the comments received from the Check of Concepts and ensure issues were resolved appropriately.
6. Resolve gaps or discrepancies that exist and prepare the draft standard and all other documents needed for the Internal Review.
7. Conducts a project review with the Modeling Experts, as needed.
8. 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. Determines what SDTM, CDASH examples are needed for the TA User Guide.
2.  Builds on the initial gap analysis to determine if new metadata needs to be developed. If there are gaps, the team resolves them. Otherwise, the team begins to develop metadata and examples.

1. Reviews the output of the initial scoping and planning stage and identifies potential areas that will require new constructs in SDTM
2. Completes the gap analysis on SDTM mappings
3. Ensures proposed standards are aligned with SDTM
4. Collaborates on the development and review of TA education materials to ensure accuracy and completeness, as needed.
5. 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
4. Coordinates review of CDASH training material with team
5. Helps the Metadata Developer 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
4. Collaborates on the development and review of TA education materials to ensure accuracy and completeness
5. Determines what analysis, metadata, and ADaM dataset examples are needed for the TA User Guide.

1. Provides copy-editing support for all CFAST project teams
2. Develops content for easy reading and understanding, maintaining consistency across all TA User Guides
3. Maintains formatting and layout of the document
4. Generates and maintains the formal references list
5. Proofs and converts document for publication
6. Ensures permissions for graphs and text are acquired from copyright holders as appropriate
7. Coordinates comment resolution with Project Manager, and ensures appropriate changes are made in the respective standards document
8. Maintains the CDISC TA User Guide Template
9. 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. Facilitates consolidation of clinical data elements and terms
3. 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
4. Reviews and assists in the search of medical literature and regulatory guidance to ensure appropriate references are included, cited and followed, as needed
5. Ensures examples in the TA guide are appropriate and clinically accurate, ensures the draft standard is understandable for the implementation community
6. Assists team as needed to resolve comments
7. Collaborates on the development and review of TA education materials to ensure accuracy and completeness
8. Writes relevant sections of the TA User Guide and reviews examples to ensure clinical accuracy and plausibility

1. Contributes and writes and reviews sections of TA standards document, as needed
2. Edits sections based on input from reviewers, as needed
3. Works with Technical Writer to improve and enhance existing templates and approaches
4. Writes relevant sections of the TA User Guide and reviews examples to ensure clinical accuracy and plausibility

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.