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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.. | ||
| Metadata Developer | Defines any concepts that have not been addressed in current CDISC standards to reach a common understanding with the Clinical Expert. | |||
| 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. | |||
| Metadata Developer | Creates concept maps | |||
| SDTM Expert / SDS Team | 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. | 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 Ensures 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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| Project Team | Refines the concept maps and list of concepts as necessary. | |||
| Project Manager | Submits all examples to the Global Governance Group (GGG) for approval. | |||
| Project Team | Refines the examples based on GGG feedback. | |||
| GGG (Global Governance Group) | Approves the modeling before the team can move to stage 2 | |||
| Project Manager | Updates the project plan and project charter, and notifies all parties involved | 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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