New Variables Timing New Variables Timing and Identifiers and Identifiers
SDTM IG Then and Now - CDISC Portal
SDTM IG Then and Now - CDISC Portal
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<strong>New</strong> <strong>Variables</strong> : Trial<br />
Summary<br />
• TSVALNF Parameter Null Flavor<br />
• TSVALCD Parameter Value Code<br />
• TSVCDREF Name of the Reference<br />
Terminology<br />
• TSVCDVER Version of the Reference<br />
Terminology
Amendment 1 Changes<br />
• MedDRA Terms added to Events<br />
• --TRTEM (Treatment Emergent Flag) not<br />
included<br />
• <strong>New</strong> DM variables added
Changes to Trial Design<br />
• <strong>New</strong> variables for TS<br />
• Addition of NULL FLAVOR for TS<br />
• <strong>New</strong> Codes for TS
TS: Trial Summary
TS: Null Flavor<br />
• Embodied in the ISO 21090 st<strong>and</strong>ard,<br />
“Health Informatics – Harmonized data<br />
types for information exchange<br />
• An ancillary piece of data that provides<br />
additional information when its primary<br />
piece of data is null (has a missing value)<br />
• Uses Controlled Terminology<br />
• Test for future use in other domains
Oncology Domains<br />
• TU – Tumor Identification<br />
• TR – Tumor Results<br />
• RS – Disease Results<br />
• Originally developed based RECIST<br />
criteria<br />
• SDTM Oncology Sub-Team working to<br />
exp<strong>and</strong> usage
Oncology Domains<br />
• TU – Tumor Identification<br />
• Used to uniquely identify tumors, classify<br />
them, identify location, how/who identified<br />
them<br />
• Per RECIST:<br />
• Target<br />
• Non-Target<br />
• <strong>New</strong> Tumor<br />
• H<strong>and</strong>les new, splits <strong>and</strong> merges<br />
• Uses --LNKID to identify <strong>and</strong> relate tumors
TUMIDENT Control<br />
Terminology
TUTESTCD Control<br />
Terminology
Oncology Domains<br />
• TR – Tumor Results<br />
• Contains quantitative measurements /<br />
qualitative assessments of tumors in TU<br />
• TRTESTCD/TRTEST – uses Control<br />
Terminology – no derivations by sponsor<br />
• If too small – use criteria lower limit (5mm)<br />
• TRACPTFL – only used if multiple<br />
evaluators<br />
• User TREVALID/TREVAL to identify<br />
evaluators
TRTESTCD Control<br />
Terminology
Oncology Domains<br />
• RS – Disease Results<br />
• Contains response evaluations as<br />
determined from results in TR<br />
• Use --LNKGRP to link with TR domain<br />
• RSTESTCD/RSTEST – uses Control<br />
Terminology – no derivations by sponsor<br />
• RSCAT – identifies criteria/CLINICAL<br />
ASSESSMENT<br />
• RSACPTFL – only used if multiple<br />
evaluators<br />
• User RSEVALID/RSEVAL to identify<br />
evaluators
RSTESTCD Control<br />
Terminology
RSSTRESC Control<br />
Terminology
TU Example
TR Example
TU Example<br />
(split/merge/new)
TR Example<br />
(split/merge/new)
RS Example
RELREC Example
SDTM Oncology Sub-team<br />
Activities<br />
• Control Terminology Updates<br />
• Response versus Remission<br />
• <strong>New</strong> TRTESTs<br />
• Collect Response Criteria (90+)<br />
• MO vs. TR for Liver/Spleen Measurements<br />
• RU for Assessments w/o Targets<br />
• End of Study/Trt<br />
using DSSCAT (death as outcome)<br />
• Review CV Usage of TU/TR
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