Transcript Moving from SDTM 3.1.2 to 3.1.4 - Overview

Moving from SDTM IG
3.1.2 to 3.1.4
Overview
Monika Kawohl
Principal Statistical Programmer
Accovion
Are we all up-to-date with the latest developments?
RS?
Disease Response Domain (SDTMIG 3.1.3)
AESOCCD?
RFICDTC?
DU?
Primary System Organ Class Code in AE (SDTMIG 3.1.3)
Date/Time of Informed Consent in DM (SDTMIG 3.1.3)
Device in Use Domain (Devices Supplement to SDTMIG in Parkinson‘s Draft UG)
SR? Skin Response Domain
MO?
(Draft SDTMIG 3.1.4 Batch 1 (or TB UG))
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
 Monthly CDISC Teams Update Webinars (free)
(slides/recordings available for members)
German Speaking CDISC UG Meeting, 25-Sep-2012
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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
German Speaking CDISC UG Meeting, 25-Sep-2012
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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)
German Speaking CDISC UG Meeting, 25-Sep-2012
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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
German Speaking CDISC UG Meeting, 25-Sep-2012
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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.,
2
date of symptom onset, date diagnosed, date confirmed
options:
-
Findings About (utilize existing concept)
-
Clinical Timings (new concept)
German Speaking CDISC UG Meeting, 25-Sep-2012
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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)
German Speaking CDISC UG Meeting, 25-Sep-2012
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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
German Speaking CDISC UG Meeting, 25-Sep-2012
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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
German Speaking CDISC UG Meeting, 25-Sep-2012
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