Monika Kawohl Principal Statistical Programmer Accovion

1. Moving from SDTM IG 3.1.2 to 3.1.4 Overview Monika Kawohl Principal Statistical Programmer Accovion

2. Are we all up-to-date with the latest developments? RS? Disease Response Domain (SDTMIG 3.1.3) • Monthly CDISC Teams Update Webinars (free)(slides/recordings available for members) AESOCCD? Primary System Organ Class Code in AE (SDTMIG 3.1.3) RFICDTC? Date/Time of Informed Consent in DM (SDTMIG 3.1.3) DU? Device in Use Domain (Devices Supplement to SDTMIG in Parkinson‘s Draft UG) SR? Skin Response Domain (Draft SDTMIG 3.1.4 Batch 1 (or TB UG)) MO? Morphology Domain (Draft SDTMIG 3.1.4 Batch 2 (or multiple Therapeutic Area UGs)) EC? Exposure as Collected Domain (Draft SDTMIG 3.1.4 Batch 1) AP? Prefix for Associated Persons Domains (Supplement to SDTMIG in Parkinson‘s Draft UG) BPI? QSCAT value for Brief Pain Inventory Questionnaire (Controlled Terminology File for QS) def:WhereClauseDef? new element in Draft define.xml v2.0

3. SDTM IG 3.1.3 (Final) • DM Update (previously 3.1.2 amendment) • AE Update (previously 3.1.2 amendment) • TS Update • Oncology Domains • Tumor Identification (TU), Tumor Results (TR) • Disease Response (RS) – applicable also for other diseases • Variable Length Considerations • Minor Edits (Labels, Roles, etc.) • Working with SDTM IG 3.1.3 (3.1.2 IG + 3.1.3 Annotations) • It‘s all about finding the correct

4. SDTM IG 3.1.4 Batch 1 (Draft) • Exposure Domains Supplement • Exposure (EX), Exposure as Collected (EC) – Interventions Domains • Immunogenicity Domains Supplement • Immunogenicity Specimen Assessments (IS) - Findings Domain • assessments, which determine whether a therapy caused/induced an immune response (e.g. vaccines) • Skin Response (SR) - Findings About Domain • dermal responses to antigens • Reproductive Details Domain • Reproductive Details (RD) – Findings Domains • e.g. childbearing status, reproductive history (# pregnancies, # births)

5. SDTM IG 3.1.4 Batch 2 (in preparation) • Cardiovascular Physiology (CV) - Findings Domain • Results of a cardiovascular diagnostic procedure • Death Details (DD) – Findings Domain • Death details collected in addition to AE data • Microscopic (MI) - Findings Domain • Results from a microscopic study of characteristic tissue abnormalities • Morphology (MO) - Findings Domain • Macroscopic results seen by the naked eye or results from procedures • Procedures (PR) - Interventions Domain • Details on therapeutic or diagnostic procedures (NOT their results) • Subject Status Domain (SS) – Findings Domains, e.g. survival status

6. SDTM IG 3.1.4 Batch 2 (in preparation) • SDS Team Proposal Documents • Alternative Method of submitting Supplemental Qualifier variables • allow non-standard variables to be included in the parent datasets • Conditions when this practice would be permitted • Managing Multiple Dates • e.g., date of symptom onset, date diagnosed, date confirmed • 2 options: • Findings About (utilize existing concept) • Clinical Timings (new concept)

7. Therapeutic/Disease Area Standards • Alzheimer‘s Disease (Final) • Tuberculosis (Final) • Pain (Final) • Parkinson‘s Disease (Draft) • Virology (Draft) – VR, PF, PG, PB, SB • Polycystic Kidney Disease (in preparation) • Cardiovascular Disease (in preparation)

8. Therapeutic/Disease Area (TA/DA) Standards • SDTM Implementation for a specific TA/DA • some include annotated CRFs • Built based on SDTMIG • Conventions for use of existing domains • e.g., Primary Diagnosis => MH • Introduction of new domains for provisional use • Associated Persons (AP--) domains (see Parkinson‘s) • Device domains (Draft) (see Parkinson‘s) • Contents of TA/DA standards also usable for other indications

9. Other • Pharmacogenomics/Genetics Domains (updated Draft in preparation) • Questionnaires • aCRFs and specifications incl. in Pain TA User Guide • Valid value ranges (char. + num.) in SUPPQS • Terminology for 30+ questionnaires (Final) – separate CT File