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SDTM - The SDTM Standard Domain Models

The collected data for a given study may use standard domains from this and other SDTM implementation guides as well as additional custom domains based on the 3 general observation classes. A list of standard domains is provided in Section 3.2.1, Dataset-level Metadata. Final domains will be published only in an SDTM implementation guide (this guide or another implementation guide, e.g., SDTMIG for Medical Devices). Therapeutic-area standards projects and other projects may develop proposals for additional domains. Draft versions of these domains may be made available in the CDISC wiki in the SDTM the SDTM Draft Domains space (https://wiki.cdisc.org/display/SDD/SDTM+Draft+Domains+Home).

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