Trial Summary Information contains 1 record for each trial summary characteristic. Trial Summary is used to record basic information about the trial (e.g., trial phase, protocol title, design objectives).

Trial Summary—One Record per Trial Summary Parameter

SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

#Variable NameVariable LabelTypeFormatRoleVariable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotesExamples
1STUDYIDStudy IdentifierChar
Identifier

C83082

A sequence of characters used by the sponsor to uniquely identify the study.



2DOMAINDomain AbbreviationChar
Identifier

C49558

An abbreviation for a collection of observations, with a topic-specific commonality.

2-character abbreviation, which must be "TS".
3TSSEQSequence NumberNum
Identifier



Sequence number to ensure uniqueness within the dataset.
4TSGRPIDGroup IDChar
Identifier



Used to tie together a group of related records.
5TSPARMCDTrial Summary Parameter Short NameChar
Topic



TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that TSPARMCD will need to serve as variable names."AGEMIN", "AGEMAX"
6TSPARMTrial Summary ParameterChar
Synonym QualifierTSPARMCD


Term for the trial summary parameter. The value in TSPARM cannot be longer than 40 characters."Planned Minimum Age of Subjects", "Planned Maximum Age of Subjects"
7TSVALParameter ValueChar
Result Qualifier



Value of TSPARM. If TSVAL is null, a value is required for TSVALNF. Text over 200 characters can be added to additional columns TSVAL1-TSVALn."ASTHMA" when TSPARM value is "Trial Indications"
8TSVALNFParameter Null FlavorChar
Result Qualifier



Null flavor for the value of TSVAL describing the reason the value is null, to be populated only if TSVAL is null.
9TSVALCDParameter Value CodeChar
Result Qualifier
Not in nonclinical trials

Code of the term in TSVAL from the reference terminology cited in TSVCDREF.
10TSVCDREFName of the Reference TerminologyChar
Result Qualifier
Not in nonclinical trials

The name of the reference terminology or standard format from which TSVALCD is taken.

"CDISC CT", "SNOMED", "ISO 8601"
11TSVCDVERVersion of the Reference TerminologyChar
Result Qualifier
Not in nonclinical trials

The version number of the reference terminology cited in TSVCDREF, if applicable.

  • No labels