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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. |
| 4.1 | QRS Representative | Expands the initial gap analysis, identifies questionnaires that are needed and initiates the process for acquiring permissions. |
| 4.2 | QRS Representative / Clinical Expert | Reviews the list of instruments and identifies those that need development. |
| 5.0 | 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 Expert | Evaluates new and different research concepts to ensure the data are clearly understood. |
| 8.0 | Metadata Developer | Creates concept maps |
| 9.0 | SDTM Expert / SDS Team | Works with the Project Team to address areas not covered by the current SDTMIG. |
| 10.0 | Metadata Developer | Refines Deliverable Plan. |
| 11.0 | Clinical Expert / Clinical SMEs | Ensures the core concepts under development are adequate and appropriate, and that there are no significant concepts missing. |
| 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. |
General Workflow
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