SDSP-002-04 SDTM v1.1 / SDTM v1.1 (like) SDTM datasets follow CDISC without supplemental qualifiers. SDTM IG 3.1.1 SDSP-002-05 Some ADaM datasets have variables. SDSP-002-06 Studies in CDISC SDTM – Efficacy data is in the EF dataset which has a findings structure ADaM v1.1 ADaM V1.1 (like) Cancer Medications prior to the study are in the PT sponsor defined custom dataset which has an intervention structure There are no trial design datasets for these studies define.xml 1.0 define.pdf Item ADaM – Followed as much as possible. Somewhat limited as no IG released. PDF – No define.xml as define.pdf was defined. SDTM v1.2 / Oncology Domains SDSP-002-10 SDTM Study uses draft Oncology domains (TU, TR, RS) – SDTM IG 3.1.2 (draft) ADaM v2.1 / ADAE ADaM Study uses ADAE the new ADaM occurrence model. – ADaM IG 1.0 SDTM v1.3 / Oncology Domains SDTM Study uses draft Breast Cancer standards – SDSP-002-15 SDTM IG 3.2 (draft) SDSP-002-20 ADaM v2.1 / ADAE ADaM Study uses a BDS version of ADAE in addition to ADAE. – ADaM IG 1.0
SDSP-002-04 SDSP-002-05 SDSP-002-06 SDTM v1.1 / SDTM IG 3.1.1 ADaM v1.1 define.xml 1.0 SDTM v1.1 (like) ADaM V1.1 (like) define.pdf Item SDTM datasets follow CDISC without supplemental qualifiers. Some ADaM datasets have variables. Studies in CDISC SDTM – Efficacy data is in the EF dataset which has a findings structure Cancer Medications prior to the study are in the PT sponsor defined custom dataset which has an intervention structure There are no trial design datasets for these studies ADaM – Followed as much as possible. Somewhat limited as no IG released. PDF – No define.xml as define.pdf was defined. SDSP-002-10 SDTM v1.2 / SDTM IG 3.1.2 ADaM v2.1 / ADaM IG 1.0 Oncology Domains (draft) ADAE SDTM – Study uses draft Oncology domains (TU, TR, RS) ADaM – Study uses ADAE the new ADaM occurrence model. SDSP-002-15 SDSP-002-20 SDTM v1.3 / SDTM IG 3.2 ADaM v2.1 / ADaM IG 1.0 Oncology Domains (draft) ADAE SDTM – Study uses draft Breast Cancer standards ADaM – Study uses a BDS version of ADAE in addition to ADAE.
SDSP_Example_Oncology.docx