P21 community validation: SDTM

[kaz462]

• If all SDTM datasets are needed, the work has been done before: https://github.com/phuse-org/TestDataFactory/blob/main/Updated/TDF_SDTM/pinnacle21-report-TDF_SDTM.xlsx

• If we only need the SDTM datasets that used in pilot3, which includes dm, ae, suppae, ex, vs, sv, sc, mh, qs, ds, lb, supplb, ts, I validated them through P21 community with SDTM define.xml, the report is here: pinnacle21-report-2023-05-03T11-28-10-358.xlsx

  • The report indicated an issue - MedDRA not configured, because I didn’t manage to install MedDRA with P21 community, @laxamanaj do we need to resolve this issue? I'm not sure which MedDRA version is used and where to locate the corresponding MedDRA files

[kaz462]

Decision: include all SDTM datasets, use existing P21 report https://github.com/phuse-org/phuse-scripts/blob/master/data/sdtm/TDF_SDTM_v1.0/pinnacle21-report-TDF_SDTM.xlsx

[kaz462]

Updated decision per meeting on May 12, 2023 - Sourcing all SDTM datasets from https://github.com/RConsortium/submissions-pilot3-adam/pull/14, generate SDTM P21 report based on:

• SDTM-IG 3.1.2 (FDA)
• SDTM CT Version: 2011-12-09
• Validation Engine Name: FDA 2204.1
• Software Version (Pinnacle 21® Community): 4.0.2
• Ignore MedDRA/SNOMED not configured issue