Therapeutic Area Projects: At the beginning of this stage, the metadata modeling approach for new concepts is defined by the Metadata Developers. Using Metadata Display Templates, Metadata Developers evaluate 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. Metadata Developers, with the help of the SDTM Expert, determine 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. See Appendix B for additional details.
Metadata Developers, with the help of the CDASH Representative, determine 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.
See the CDASH Toolkit for assistance.
The TA Statistical Programmer, with the help of the 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.
For the clinical sections of the TA User Guide, it is (mostly) feasible to itemize all of the data collected in the clinical trial. For the analysis section, the trial design, phase of trial, population of interest, etc., all influence the analysis needs and objectives. Therefore, the aim is to develop an analysis section that is descriptive but not prescriptive, a robust example of what a 'typical' analysis dataset would look like that is designed to analyze a particular primary endpoint. Analysis issues (censoring issues, adjudication issues, covariates, etc.), development of individual examples or standards for all analysis issues will not occur.
Summary of the analysis process steps:
- Identify clinical endpoints.
- Itemize how clinical endpoints translate into statistical endpoints (indicate primary and secondary).
- Develop examples and illustrate (via analysis results metadata) how to go from the ADaM dataset to the analysis.
During this stage, the Metadata Developers build 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.
The Global Governance Group must approve the modeling before the TA User Guide draft may be posted for internal review. The Project Manager should alert the Global Governance Group when the draft is nearing internal review.
Foundational Projects: The method of modeling may vary by team, and new tools are being used to support this stage of standards development in the CDISC SHARE metadata repository, currently in development.
During this phase, project teams 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. See Appendix B for additional details. Team Liaisons will weigh in to assess overlaps, conflicts or effects on other foundational standards.
Examples using sample data are encouraged to improve understanding of all key concepts and are created by Metadata Developers. Data included in the examples must be plausible to clinical users. For example, a numeric test result should be consistent with what would be seen in clinical practice. Examples should be created to illustrate key points of the therapeutic area data. Also, examples should avoid using actual product trade names.
All Project Managers should maintain a project decision tracker, so Project Teams have a central location to find this information. Decision Trackers are located in the CDISC Wiki in the appropriate project space. The Project Manager checks outstanding issues, works toward resolution, and updates the tracker throughout the course of the project.
The Technical Writer begins to build the standard by incorporating content and examples as they are developed by the Metadata Developers and Concept Modelers.
The Clinical TA Expert(s), with the help of the Medical Writer, writes relevant sections of the TA User Guide and reviews examples to ensure clinical accuracy and plausibility.
The Project Manager should refer to the comments received from the Check of Concepts and ensure issues were resolved appropriately. The Project Manager should also resolve gaps or discrepancies that exist and prepare the draft standard and all other documents needed for the Internal Review. The Project Manager conducts a project review with the Modeling Experts, as needed.
The Global Governance Group must approve the modeling before the standard may be posted for internal review. The Team Lead should alert the Global Governance Group when the draft is nearing internal review.