Stage 0 Scoping and Planning | Stage 1 Concept Modeling | Stage 2 Development of Draft | Stage 3a Internal Review | Stage 3b Public Review | Stage 3c Publication |
|---|---|---|---|---|---|
| Review Process Document | Collect remaining inputs and permissions | Define metadata modeling approach for new biomedical concepts with modeling experts | Post draft standard for Internal Review | Collect public review comments | Communications Team posts the standard on www.cdisc.org |
| Review the GGG Governance Structure | Model and develop biomedical concepts | Develop detailed metadata or specifications for standard, as appropriate | Perform fit for use testing (optional) | Respond to Public Review comments and update the draft document Resolve public review comments | Communications Team announces availability of the new standard package |
| Request a Wiki Space and an accompanying JIRA project | Review concepts maps with clinical and/or relevant SMEs (if applicable) | Develop data examples consistent with metadata, as appropriate | Resolve issues and update draft standard Resolve internal review comments | GGG reviews responses to Public Review comments | |
| Perform background research and initial scoping | Refine information requirements | Develop draft standards document and review package Draft the standard | Begin to develop education materials, including Public Review webinar (if needed) | Any normative content changes need to be reviewed and approved by the GGG. | |
| Obtain approval from appropriate governance body for the scoping package | Develop terminologies (including QRS) | Review package against the QC checklist | Coordinate copy-editing | Submit additional terminology requests and complete other required activities as necessary (QRS) | |
| Obtain approval from appropriate governance body | Sign up for GGG Review | Complete public review documents | Send final document to copy editor for review | ||
| Complete internal review documents | Any normative content changes need to be reviewed by the GGG for approval to post for Public Review | Complete publication documents | |||
• Obtain Global Governance Group (GGG) approval for Internal Review (excludes QRS) GGG reps sign off for internal review | Sign up for GGG Review | Sign up for GGG Review | |||
| • Finalize draft standards document and package for Internal Review | GGG reps sign off for public review | GGG leads provide approval for publication GGG reps sign off for publication | |||
| Submit public posting package to Publication Committee | Complete publication checklist | ||||
| Communications Team posts draft for Public Review | Final approval from Heads of Standards | ||||
| Coordinate copy-editing | |||||
| Submit public posting package to Publication Committee for preparation for publication |
Overview
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