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SDTM TS — IG 3.3 Examples
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Example STUDYID DOMAIN TSSEQ TSGRPID TSPARMCD TSPARM TSVAL TSVALNF TSVALCD TSVCDREF TSVCDVER
IG33_TS_TS_001 XYZ TS 1 ADDON Added on to Existing Treatments Y C49488 CDISC 2011-06-10
IG33_TS_TS_001 XYZ TS 1 AGEMAX Planned Maximum Age of Subjects P70Y ISO 8601
IG33_TS_TS_001 XYZ TS 1 AGEMIN Planned Minimum Age of Subjects P18M ISO 8601
IG33_TS_TS_001 XYZ TS 1 LENGTH Trial Length P3M ISO 8601
IG33_TS_TS_001 XYZ TS 1 PLANSUB Planned Number of Subjects 300
IG33_TS_TS_001 XYZ TS 1 RANDOM Trial is Randomized Y C49488 CDISC 2011-06-10
IG33_TS_TS_001 XYZ TS 1 SEXPOP Sex of Participants BOTH C49636 CDISC 2011-06-10
IG33_TS_TS_001 XYZ TS 1 STOPRULE Study Stop Rules INTERIM ANALYSIS FOR FUTILITY
IG33_TS_TS_001 XYZ TS 1 TBLIND Trial Blinding Schema DOUBLE BLIND C15228 CDISC 2011-06-10
IG33_TS_TS_001 XYZ TS 1 TCNTRL Control Type PLACEBO C49648 CDISC 2011-06-10
IG33_TS_TS_001 XYZ TS 1 TDIGRP Diagnosis Group Neurofibromatosis Syndrome (Disorder) 19133005 SNOMED
IG33_TS_TS_001 XYZ TS 1 INDIC Trial Disease/Condition Indication Tonic-Clonic Epilepsy (Disorder) 352818000 SNOMED
IG33_TS_TS_001 XYZ TS 1 TINDTP Trial Intent Type TREATMENT C49656 CDISC 2011-06-10
IG33_TS_TS_001 XYZ TS 1 TITLE Trial Title A 24 Week Study of Oral Gabapentin vs. Placebo as add-on Treatment to Phenytoin in Subjects with Epilepsy due to Neurofibromatosis
IG33_TS_TS_001 XYZ TS 1 TPHASE Trial Phase Classification Phase II Trial C15601 CDISC 2011-06-10
IG33_TS_TS_001 XYZ TS 1 TTYPE Trial Type EFFICACY C49666 CDISC 2011-06-10
IG33_TS_TS_001 XYZ TS 2 TTYPE Trial Type SAFETY C49667 CDISC 2011-06-10
IG33_TS_TS_001 XYZ TS 1 CURTRT Current Therapy or Treatment Phenytoin 6158TKW0C5 UNII
IG33_TS_TS_001 XYZ TS 1 OBJPRIM Trial Primary Objective Reduction in the 3-month seizure frequency from baseline
IG33_TS_TS_001 XYZ TS 1 OBJSEC Trial Secondary Objective Percent reduction in the 3-month seizure frequency from baseline
IG33_TS_TS_001 XYZ TS 2 OBJSEC Trial Secondary Objective Reduction in the 3-month tonic-clonic seizure frequency from baseline
IG33_TS_TS_001 XYZ TS 1 SPONSOR Clinical Study Sponsor Pharmaco 1234567 DUNS
IG33_TS_TS_001 XYZ TS 1 TRT Investigational Therapy or Treatment Gabapentin 6CW7F3G59X UNII
IG33_TS_TS_001 XYZ TS 1 RANDQT Randomization Quotient 0.67
IG33_TS_TS_001 XYZ TS 1 STRATFCT Stratification Factor SEX
IG33_TS_TS_001 XYZ TS 1 REGID Registry Identifier NCT123456789 NCT123456789 ClinicalTrials.GOV
IG33_TS_TS_001 XYZ TS 2 REGID Registry Identifier XXYYZZ456 XXYYZZ456 EUDRAC
IG33_TS_TS_001 XYZ TS 1 OUTMSPRI Primary Outcome Measure SEIZURE FREQUENCY
IG33_TS_TS_001 XYZ TS 1 OUTMSSEC Secondary Outcome Measure SEIZURE FREQUENCY
IG33_TS_TS_001 XYZ TS 2 OUTMSSEC Secondary Outcome Measure SEIZURE DURATION
IG33_TS_TS_001 XYZ TS 1 OUTMSEXP Exploratory Outcome Measure SEIZURE INTENSITY
IG33_TS_TS_001 XYZ TS 1 PCLAS Pharmacological Class Anti-epileptic Agent N0000175753 MED-RT
IG33_TS_TS_001 XYZ TS 1 FCNTRY Planned Country of Investigational Sites United States of America USA ISO 3166
IG33_TS_TS_001 XYZ TS 2 FCNTRY Planned Country of Investigational Sites Canada CAN ISO 3166
IG33_TS_TS_001 XYZ TS 3 FCNTRY Planned Country of Investigational Sites Mexico MEX ISO 3166
IG33_TS_TS_001 XYZ TS 1 ADAPT Adaptive Design N C49487 CDISC 2011-06-10
IG33_TS_TS_001 XYZ TS 1 DateDesc1 DCUTDTC Data Cutoff Date 2011-04-01 ISO 8601
IG33_TS_TS_001 XYZ TS 1 DateDesc1 DCUTDESC Data Cutoff Description DATABASE LOCK
IG33_TS_TS_001 XYZ TS 1 INTMODEL Intervention Model PARALLEL C82639 CDISC
IG33_TS_TS_001 XYZ TS 1 NARMS Planned Number of Arms 3
IG33_TS_TS_001 XYZ TS 1 STYPE Study Type INTERVENTIONAL C98388 CDISC
IG33_TS_TS_001 XYZ TS 1 INTTYPE Intervention Type DRUG C1909 CDISC
IG33_TS_TS_001 XYZ TS 1 SSTDTC Study Start Date 2009-03-11 ISO 8601
IG33_TS_TS_001 XYZ TS 1 SENDTC Study End Date 2011-04-01 ISO 8601
IG33_TS_TS_001 XYZ TS 1 ACTSUB Actual Number of Subjects 304
IG33_TS_TS_001 XYZ TS 1 HLTSUBJI Healthy Subject Indicator N C49487 CDISC 2011-06-10
IG33_TS_TS_001 XYZ TS 1 SDMDUR Stable Disease Minimum Duration P3W ISO 8601
IG33_TS_TS_001 XYZ TS 1 CRMDUR Confirmed Response Minimum Duration P28D ISO 8601
Example STUDYID DOMAIN TSSEQ TSGRPID TSPARMCD TSPARM TSVAL TSVALNF TSVALCD TSVCDREF TSVCDVER
IG33_TS_TS_002 XYZ TS 1 AGEMAX Planned Maximum Age of Subjects PINF
IG33_TS_TS_002 XYZ TS 2 TPHASE Trial Phase Classification NA