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Describe each step to be taken to complete the scope of this Work Instruction in the prescribed sequence. Use active verb in the Instructions column.
| 1.0 | 2.0 |
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| Metadata Developer | Evaluate the templates or spreadsheets needed for the project and create any additional templates required |
3.0 |
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| Metadata Developer / SDTM Expert | Determines what SDTM examples are needed for the standard. If any new domains or variables are needed, proposals are developed and shared with the SDS team |
3.1 |
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| Metadata Developer / CDASH Representative | Determines what CDASH examples are needed for the TA User Guide. If any new domains or variables are needed, proposals are developed and shared with the CDASH team |
3.2 |
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| TA Statistical Programmer ADaM Expert | Determines what analysis, metadata, and ADaM dataset examples are needed for the TA User Guide. If any new standards are needed, proposals are developed and shared with the CDISC ADaM Leadership team |
4.0 |
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| Metadata Developer | Builds on the initial gap analysis to determine if new metadata needs to be developed. If there are gaps, the team resolves them. Otherwise, the team begins to develop metadata and examples. |
5.0 |
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| Metadata Developer | Develops metadata and examples |
.60 |
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| Project Team | Examine concepts and consider what specific content is needed as part of the final standards product. If any new domains or variables are needed, proposals are developed and shared with the appropriate CDISC foundational team |
7.0| Restructure metadata tables |
| Metadata Developer | Creates sample data to improve understanding of all key concepts |
8.0 |
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| Technical Writer | Begins to build the standard by incorporating content and examples as they are developed by the Metadata Developers and Concept Modelers. |
9.0| Examples |
| Clinical TA Expert / Medical Writer | Writes relevant sections of the TA User Guide and reviews examples to ensure clinical accuracy and plausibility. |
10.0| Update labels in SDTMIG |
| Concept Developer | Copies the template sheet to a new sheet, fills in the concept-level metadata, deletes any concept variable rows that are not relevant for the concept, populates or modifies Controlled Terminology and SDTM variable information as needed, and adds relevant information about associations with other concepts |
| Controlled terminology |
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| Data sciences - test upload? |
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| Domain long name alignment |
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| New QX domain |
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| New DC domain (draft name, MSI) |
11.0 |
| TA Team | Drafts a Therapeutic Area Specification in collaboration with the FDA to show the different versions of the SDTM and how they relate to domains and variables contained in TA User Guides. |
12.0| New GI domain, from SDTM draft domains |
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| Revise BE, BS, and RELSPEC |
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| Revise DV domain |
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| revise MI domain |
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| New variables |
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| Deprecation of existing variables |
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| Incorporate CDISC glossary text references into the SDTMIG |
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| Decision trees |
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| Suppqual -> NSV |
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| ACTARM |
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| RWE/RWD |
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| Conformance - legacy review (e.g., should -> must) |
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| Incorporate SDTMIG-AP |
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| Split Variable-Naming Conventions subsection in Section 4 |
| Project Manager | Refers to the comments received from the Check of Concepts and ensure issues were resolved appropriately |
. 130 |
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| Project Manager | Resolve gaps or discrepancies that exist and prepare the draft standard and all other documents needed for the Internal Review. |
14.0 |
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| Project Manager | Conducts a project review with the Modeling Experts, as needed. |
15.0 |
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| Project Manager | Alerts the Global Governance Group when the draft is nearing internal review. |
16.0 |
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| Global Governance Group | Approves the modeling before the standard may be posted for internal review. |
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General Workflow
References
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