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

Moving from SDTM IG

3.1.2 to 3.1.4 Overview

Monika Kawohl

Principal Statistical Programmer

Accovion

German Speaking CDISC UG Meeting, 25-Sep-2012 2

Are we all up-to-date with the latest developments?

Monthly CDISC Teams Update Webinars (free)(slides/recordings available for members)

RS?

DU?

RFICDTC?

AESOCCD?

SR?

MO?

EC?

AP?BPI?

Disease Response Domain (SDTMIG 3.1.3)

Date/Time of Informed Consent in DM (SDTMIG 3.1.3)

Primary System Organ Class Code in AE (SDTMIG 3.1.3)

Device in Use Domain (Devices Supplement to SDTMIG in Parkinson‘s Draft UG)

Skin Response Domain (Draft SDTMIG 3.1.4 Batch 1 (or TB UG))

Morphology Domain (Draft SDTMIG 3.1.4 Batch 2 (or multiple Therapeutic Area UGs))

Exposure as Collected Domain (Draft SDTMIG 3.1.4 Batch 1)

Prefix for Associated Persons Domains (Supplement to SDTMIG in Parkinson‘s Draft UG)

QSCAT value for Brief Pain Inventory Questionnaire (Controlled Terminology File for QS)

def:WhereClauseDef? new element in Draft define.xml v2.0


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


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)


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


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)


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)


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


OtherPharmacogenomics/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