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Expected Timelines

• SDTMIG Scope finalization in ~March 2021.

• SDTMIG Internal Review in ~ August/September 2021.

• Public Review in ~ November 2021.

• CT to support SDTMIG Public Review in ~June 2022.

• CT to support SDTMIG publication in ~September 2022.

• SDTMIG publication ~November 2022.

Notes from SDS

For IS/MB: I think we should discuss the possibility of whether new examples can be included in a “CDISC SDTM Example Library”. @Dana, I know we had discussed this as a possible option for the Genomics Team depending on what content is needed for supplemental materials. My understanding is, using this approach, updated examples may be released more frequently and this allows the SDTMIG to be an implementation guide with less time sensitive examples rather than guidance for different data types / therapeutic areas.

For PK Parameters: Can you please put this work on hold for now? Alignment on future standards development for PK is in discussion within CDISC and we expect to have more unified direction for this data early next year.

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