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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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| Step # | Role | Instructions | ||||
|---|---|---|---|---|---|---|
| 1.0 | Project Manager | Assembles project team | ||||
| 2.0 | CDISC Education Team | Assigns an Education Representative to work with the project team. | ||||
| 3.0 | Education Representative | The Education Representative conducts an initial meeting to orient the Project Manager and team on training development procedures and templates. | ||||
| 3.1 | Foundational education sub-team leads | Collaborates with CDISC education team for their respective foundational standards | ||||
| 4.0 | Project Team | Reviews of applicable questionnaires and scales used and initiates the process for collecting the required copyright permissions. | ||||
| 54.01 | QRS Representative | Expands the initial gap analysis, identifies questionnaires that are needed and initiates the process for acquiring permissions. | ||||
| 54.12 | QRS Representative / Clinical Expert | Reviews the list of instruments and identifies those that need development. | ||||
| 65.0 | Technical Writer | Sets up standard space in the wiki. | ||||
| 6.0 | Metadata Developer | Models Concepts | ||||
| 6.1 | Metadata Developer (Concept Developer) | Defines any concepts that have not been addressed in current CDISC standards to reach a common understanding with the Clinical Expert. | ||||
| 7.0 | Clinical ExpertProject Manager | Evaluates new and different research concepts with the assistance of the Clinical Expert to ensure the data are clearly understood. Performs check of concepts with targeted CDISC community. Concept maps illustrating relationships among the data are developed to facilitate this process. | ||||
| 8.0 | Metadata Developer | Creates concept maps | ||||
| 9.0 | SDTM Expert / SDS TeamSDTM Expert | Works with the Project Team to address areas not covered by the current SDTMIG. It is crucial that the SDTM Expert is included in this process and works closely with the SDS team. Any issues that cannot be resolved for the first version of the standard must be placed on the SDS issues list so that resolution can be addressed in a later version. | ||||
| 10.0 | Metadata Developer | Refines Deliverable Plan. | ||||
| 11.0 | Clinical Expert / Clinical SMEs | Ensures | Project Manager | Submit concept maps to MRC for Approval | Clinical Expert and other Clinical SMEs | Checks concepts and concept maps. The purpose of the review is to ensure the core concepts under development are adequate and appropriate, and that there are no significant concepts missing. This review limited to the team members, SMEs, FDA and other identified stakeholders. Metadata Developers Forum and Concept Modelers Forum
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| 12.0 | Project Team | Refines the concept maps and list of concepts as necessary. | ||||
| 13.0 | Project Manager | Submits all examples to the Global Governance Group (GGG) for approval. | ||||
| 13.1 | Project Team | Refines the examples based on GGG feedback. | ||||
| 14.0 | GGG (Global Governance Group) | Approves the modeling before the team can move to stage 2 | ||||
| 15.0 | Project Manager | Updates the project plan and project charter, and notifies all parties involved. Performs CDISC project review | Project Manager | Calls for a CDISC project review with CDISC Project Management and Experts. |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
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