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 Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STUDYID | Study Identifier | Char | Identifier | C83082 | A sequence of characters used by the sponsor to uniquely identify the study. | |||||
| 2 | DOMAIN | Domain Abbreviation | Char | Identifier | C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "TS". | ||||
| 3 | TSSEQ | Sequence Number | Num | Identifier | Sequence number to ensure uniqueness within the dataset. | ||||||
| 4 | TSGRPID | Group ID | Char | Identifier | Used to tie together a group of related records. | ||||||
| 5 | TSPARMCD | Trial Summary Parameter Short Name | Char | 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" | |||||
| 6 | TSPARM | Trial Summary Parameter | Char | Synonym Qualifier | TSPARMCD | 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" | ||||
| 7 | TSVAL | Parameter Value | Char | 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" | |||||
| 8 | TSVALNF | Parameter Null Flavor | Char | Result Qualifier | Null flavor for the value of TSVAL describing the reason the value is null, to be populated only if TSVAL is null. | ||||||
| 9 | TSVALCD | Parameter Value Code | Char | Result Qualifier | Not in nonclinical trials | Code of the term in TSVAL from the reference terminology cited in TSVCDREF. | |||||
| 10 | TSVCDREF | Name of the Reference Terminology | Char | 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" | ||||
| 11 | TSVCDVER | Version of the Reference Terminology | Char | Result Qualifier | Not in nonclinical trials | The version number of the reference terminology cited in TSVCDREF, if applicable. |
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