Examples SDTM.TS

Example	STUDYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	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