Below you find a table with the proposed slots/topics for the planned "Impact and Change Summary Discussion on the SDTM Implementation Guide v3.3 and SDTM Model v1.7" on our next German CDISC User Network Meeting in Eschborn (Frankfurt) on Sep. 25th 2019.
Volunteers for any of the proposed slots for the F-2-F Meeting on Sep. 25th should please contact Kurt Hellstern in the next monthly User Network Telephone Conferences or via the network mailing list (deun[at]lists.cdisc.org).
Tabelle – SDTM-IG v3.3 Updates
A) Removed Domains + CT
e.g. John Doe
B) New Domains
Section 5: Special Purpose
Section 7: Trial Design Model
Section 6.1: Interventions
Section 6.3.13: Findings (Questionnaires, Ratings, and Scales)
Section 6.3.10: Findings I (Morphology/Physiology Domains Subgroup)
Section 6.3.10: Findings II (Morphology/Physiology Domains Subgroup)
New SDTM-IG Section 9: Study References
Guidance on EPOCH
Extended Use of RS
* DI and PB domains are referenced from the SDTMIG-MD (SDTM-IG for Medical Devices) and SDTMIG-PGx (SDTM-IG for Pharmacogenomic/Genetics)