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List terms (abbreviations, acronyms, technical jargon) referenced in this Work Instruction useful at adding clarity. Put "Not applicable." if this section is not applicable.
| Term | Definition |
|---|---|
| SDTM | 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. |
| CDASH | 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). |
| ADaM | 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). |
| CDISC SHARE metadata repository | |
| Decision Tracker | Decision Trackers are located in the CDISC Wiki in the appropriate project space. Project Manager maintain it so Project Teams have a central location to find this information. |
Roles & Responsibilities
Lists all roles and their responsibilities relevant to this Work Instruction.
| Role | Responsibilities |
|---|---|
| Project Manager | Refers to the comments received from the Check of Concepts and ensure issues were resolved appropriately. Resolve gaps or discrepancies that exist and prepare the draft standard and all other documents needed for the Internal Review. Conducts a project review with the Modeling Experts, as needed. 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. |
| Metadata Developer | Determines what SDTM, CDASH examples are needed for the TA User Guide. 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. |
| SDTM Expert | Helps the Metadata Developer determine what examples are needed for the standard. |
| CDASH Representative | Helps the Metadata Developer determine what examples are needed for the TA User Guide. |
| ADaM Expert | Helps TA Statistical Programmer determine what examples are needed for the TA User Guide. |
| TA Statistical Programmer | Determines what analysis, metadata, and ADaM dataset examples are needed for the TA User Guide. |
| Project Team | |
| Technical Writer | Builds the standard by incorporating content and examples as they are developed by the Metadata Developers and Concept Modelers. |
| Clinical TA Expert | Writes relevant sections of the TA User Guide and reviews examples to ensure clinical accuracy and plausibility. |
| Medical Writer | Writes relevant sections of the TA User Guide and reviews examples to ensure clinical accuracy and plausibility. |
| Concept Developer | |
| Global Governance Group | Approves the modeling before the standard may be posted for internal review. |
Instructions
Describe each step to be taken to complete the scope of this Work Instruction in the prescribed sequence. Use active verb in the Instructions column.
| Step # | Role | Instructions |
|---|---|---|
| 1.0 | Metadata Developer | Defines the metadata modeling approach for new concepts is defined by the Metadata Developers. Uses Metadata Display Templates, evaluates the templates or spreadsheets needed for the project and create any additional templates required. These templates will be in the form of metadata display templates until the SHARE environment is available for concept development. |
| 1.1 | Metadata Developer SDTM Expert | Determines what SDTM examples are needed for the standard. If any new domains or variables are needed, proposals are developed and shared with the SDS team. |
| 1.2 |
General Workflow
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Metadata Developer CDASH Representative | Determines what CDASH examples are needed for the TA User Guide. If any new domains or variables are needed, proposals are developed and shared with the CDASH team. | |
| 1.3 | TA Statistical Programmer ADaM Expert | Determines what analysis, metadata, and ADaM dataset examples are needed for the TA User Guide. If any new standards are needed, proposals are developed and shared with the CDISC ADaM Leadership team. This work may extend to future versions on some projects if not completed within the 12-18 month time frame |
| 1.4 | Metadata Developer | 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. |
| 1.5 | Project Team | 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. Team Liaisons will weigh in to assess overlaps, conflicts or effects on other foundational standards. |
| 2.0 | Metadata Developer | Creates sample data to improve understanding of all key concepts. Data included in the examples must be plausible to clinical users. Examples should be created to illustrate key points of the therapeutic area data. Also, examples should avoid using actual product trade names. |
| 2.1 | Technical Writer | Begins to build the standard by incorporating content and examples as they are developed by the Metadata Developers and Concept Modelers. |
| 2.2 | Clinical TA Expert Medical Writer | Writes relevant sections of the TA User Guide and reviews examples to ensure clinical accuracy and plausibility. |
| 2.3 | Concept Developer | 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, populates or modifies Controlled Terminology and SDTM variable information as needed, and adds relevant information about associations with other concepts |
| 3.0 | Project Manager | Refers to the comments received from the Check of Concepts and ensure issues were resolved appropriately. |
| 3.1 | Project Manager | Resolve gaps or discrepancies that exist and prepare the draft standard and all other documents needed for the Internal Review. |
| 3.2 | Project Manager | Conducts a project review with the Modeling Experts, as needed. |
| 3.3 | Project Manager | Alerts the Global Governance Group when the draft is nearing internal review. |
| 4.0 | Global Governance Group | Approves the modeling before the standard may be posted for internal review. |
General Workflow
References
List references pertinent to this Work Instruction, e.g., COP-001.