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The purpose of this stage is to develop an approach for meeting the initial requirements and define in more detail the information that will comprise the proposed new or enhanced standard, including comparisons to existing standards.
Scope
Concept Modeling should be used as an opportunity for cross-project review of modeling approaches, to minimize inconsistenciesThe deliverable for Stage 1 is a list of biomedical concepts, and other relevant artifacts, such as concept maps or terminology requests.
Prerequisites
Requirements assessment, project charter and the scoping package.
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| Term | Definition |
|---|---|
| TLC Review Team | Technical Leadership Committee The TLC is made up of Foundational Standards Team Leads. This committee discusses issues pertaining to the Foundational Standards. The TLC also develops the agenda for CDISC IntraChanges and typically leads sessions during these events. |
QRS | Questionnaires, Ratings and Scales. |
| MRC | Medical Research Council. |
| SDS | Submission Domain Standard. |
| CDISC foundational standards | CDISC Foundational Standards are the basis for the complete CDISC suite of standards, supporting the clinical and non-clinical research process from protocol through data collection, data exchange, data management, data analysis and reporting. These standards focus on the core principles for defining research data standards applicable to most research studies, and include models, domains and specifications for data representation. |
| Global Governance Group (GGG) | Responsible for reviewing and approving all draft standards. This group is composed of representatives from each of the foundational teams who have been empowered to review and approve modeling decisions on behalf of their team. The GGG meetings are open to any CDISC team member. |
| CDISC JIRA issue tracker | Jira is a software created by Atlassian for tracking bugs and issues. It is used by the CDISC Library Support Technician ("Support Technician") and the Azure Active Directory Administrator ("Azure Admin") to track CDISC Library accounts. |
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