Trial Summary (TS)

A trial design domain that contains one record for each trial summary characteristic. This domain is not subject oriented.

The Trial Summary (TS) dataset allows the applicant to submit a summary of the trial in a structured format. TOBA-323 - Getting issue details... STATUS Each record in the TS dataset contains the value of a parameter, a characteristic of the trial. For example, TS is used to record basic information about the study such as trial phase, protocol title, and trial objectives. The TS dataset contains information about the planned and actual trial characteristics.

Example

This example shows a subset of published controlled terminology parameters and the relationship of values across response variables TSVAL, TSVALNF, TSVALCD, TSVCDREF, and TSVCDVER. Text over 200 characters can be added to additional columns TSVAL1-TSVALn. This example does not include any text over 200 characters. Applicants should consult with regulators regarding which parameters are expected/required to be submitted. When required items are not applicable, TSVALNF may be used.

TSVALNF contains a “null flavor,” a value that provides additional coded information when TSVAL is null. For example, for TSPARM = "AGEMAX" (Planned Maximum Age of Subjects), there is no value if a study does not specify a maximum age. In this case, the appropriate null flavor is "PINF", which stands for "positive infinity." TSVALNF can also be used in a case where the value of a particular parameter is unknown. However, in a tobacco study conducted in healthy volunteers where the study/trial phase classification is not established, the value (TSVAL) for TSPARM = "TPHASE" would be "NOT APPLICABLE". TSVAL should not be left null in this case.

Sequence number is given to ensure uniqueness within a parameter. In this example, TSPARMCD (FCNTRY) is repeated twice to indicate that the study was conducted in the US and Canada. TSSEQ is assigned "1" for the US and "2" for Canada.

TSGRPID is used to tie together a group of related records. For example, DCUTDTC, and DCUTDESC below are tied together using TSGRPID.

ts.xpt

Row	STUDYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF	TSVALCD	TSVCDREF	TSVCDVER
1	XYZ	TS	1		ACTSUB	Actual Number of Subjects	304
2	XYZ	TS	1		ADAPT	Adaptive Design	N
3	XYZ	TS	1		ADDON	Added on to Existing Treatments	Y		C49487	CDISC CT	2023-03-31
4	XYZ	TS	1		AGEMAX	Planned Maximum Age of Subjects	PINF
5	XYZ	TS	1		AGEMIN	Planned Minimum Age of Subjects	P18Y			ISO 8601
6	XYZ	TS	1	PA	DCUTDTC	Data Cutoff Date	2010-04-10			ISO 8601
7	XYZ	TS	1	PA	DCUTDESC	Data Cutoff Description	PRIMARY ANALYSIS
8	XYZ	TS	1		FCNTRY	Planned Country of Investigational Sites	USA			ISO 3166-1 Alpha-3
9	XYZ	TS	2		FCNTRY	Planned Country of Investigational Sites	CAN			ISO 3166-1 Alpha-3
10	XYZ	TS	1		INDIC	Trial Disease/Condition Indication	Tobacco smoking consumption		266918002	SNOMED	2011-03
11	XYZ	TS	1		LENGTH	Trial Length	P3M			ISO 8601
12	XYZ	TS	1		NARMS	Planned Number of Arms	3
13	XYZ	TS	1		OBJPRIM	Trial Primary Objective	Change in concentration of Nicotine in urine from baseline
14	XYZ	TS	1		OBJSEC	Trial Secondary Objective	Change in concentration of Cotinine in urine from baseline
15	XYZ	TS	1		PLANSUB	Planned Number of Subjects	300
16	XYZ	TS	1		RANDOM	Trial is Randomized	Y		C49488	CDISC CT	2023-03-31
17	XYZ	TS	1		REGID	Registry Identifier	NCT123456789		NCT123456789	ClinicalTrials.gov
18	XYZ	TS	2		REGID	Registry Identifier	XXYYZZ456		XXYYZZ456	EudraCT
19	XYZ	TS	1		SENDTC	Study End Date	2011-04-01			ISO 8601
20	XYZ	TS	1		SEXPOP	Sex of Participants	BOTH		C49636	CDISC CT	2023-03-31
21	XYZ	TS	1		APPLCNT	Applicant	TobaccoCo		123456789	D-U-N-S NUMBER
22	XYZ	TS	1		STOPRULE	Study Stop Rules	NONE
23	XYZ	TS	1		TBLIND	Trial Blinding Schema	DOUBLE BLIND		C15228	CDISC CT	2023-03-31
24	XYZ	TS	1		TCNTRL	Control Type	ACTIVE		C49649	CDISC CT	2023-03-31
25	XYZ	TS	1		TITLE	Trial Title	A 3 month study of tobacco biomarkers in subjects using ENDS devices
26	XYZ	TS	1		TDIGRP	Diagnosis Group		NA
27	XYZ	TS	1		TINDTP	Trial Intent Type		NA	C49656	CDISC CT	2023-03-31
28	XYZ	TS	1		TPHASE	Trial Phase Classification	NOT APPLICABLE
29	XYZ	TS	1		TTYPE	Trial Type	PHARMACOKINETIC		C49663	CDISC CT	2023-03-31
30	XYZ	TS	1		STYPE	Study Type	INTERVENTIONAL		C98388	CDISC CT	2023-03-31
31	XYZ	TS	1		SDTIGVER	SDTM IG Version	3.4
32	XYZ	TS	1		STDMVER	SDTM Version	1.4
33	XYZ	TS	1		TIGVER	Tobacco IG Version	1.0

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Trial Summary (TS)