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Description

ts.xpt, Trial Summary — Trial Design. One record per trial summary parameter value, Tabulation.


Specification

TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1

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

Controlled Terms, Codelist, or Format

Role

CDISC Notes

Core

STUDYID

Study Identifier

Char


Identifier

Unique identifier for a study within the submission.

Req

DOMAIN

Domain Abbreviation

Char

TS

Identifier

Two-character abbreviation for the domain most relevant to the observation.

Req

TSSEQ

Sequence Number

Num


Identifier

Sequence number used to ensure uniqueness within a TSPARMCD. Allows inclusion of multiple records for the same TSPARMCD, and can be used to join related records.

Req

TSGRPID

Group Identifier

Char


Identifier

Used to tie together a group of related records. This is not the applicant-defined protocol group number.

Exp

TSPARMCD

Trial Summary Parameter Short Name

Char

(STSPRMCD)

Topic

Short character value for the trial design characteristic described in TSPARM. Value must be 8 characters or less.

Req

TSPARM

Trial Summary Parameter

Char

(STSPRM)

Synonym Qualifier

Term for the trial parameter. Value must be 40 characters or less.

Req

TSVAL

Parameter Value

Char


Result Qualifier

Value of the TS parameter (e.g., "FDA" when TSPARM is GLP Type). The values for some parameters may be subject to controlled terminology. See the Controlled Terms, Codelist, or Format column in Section 7.6.3 that lists all defined parameters. TSVAL can only be null if TSVALNF is populated.

Exp

TSVALNF

Parameter Null Flavor

Char

ISO 21090 NullFlavor

Record Qualifier

Null flavor for the value of TSPARM, to be populated only if TSVAL is null.

Perm


Assumptions

  1. The intent of the Trial Summary (TS) domain is to provide a summary of the study information in dataset format. This is not subject-level data.
  2. TSVAL may have controlled terminology, depending on the value of TSPARMCD.
  3. TS allows for 1 TSVAL value to span multiple variables (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. This is similar to the conventions used in the Comments (CO) domain to accommodate COVAL values longer than 200 characters. TS and CO are special-purpose domains that allow additional TSVAL/COVAL variables to be added to the dataset, in order to accommodate values longer than 200 characters.
  4. For some types of studies, there will be multiple records in the TS dataset for a single parameter, such as GLP type when a study is conducted in such a way that it complies with several GLP guidances. In this case, when TSPARMCD = GLPTYP there may be 2 (or more) records for TSVAL, one with the value "OECD" and the other with the value "FDA."
  5. Use TSGRPID for linking together multiple parameters (e.g., assign a TSGRPID to show a relationship between multiple species to multiple strains, or assign a TSGRPID to show a relationship between several laboratory sites and locations and individual investigators). Note that any parameters with the same GRPID are related.
  6. The TSSEQ variable is required to identify each record as unique, in cases where the same TSPARMCD is used within the dataset. The TSSEQ variable must be populated for all records within the TS dataset.
  7. Some --PARMCD values are available to both the TS and Trial Sets (TX) domains in order to show the relevant information at the appropriate level. If TSPARMCD values do not differ across trial sets, then these should be described in the TS and need not be in the TX domain.
  8. A study can include more than one genetic toxicology assay (indicated by values for GNTXAID).

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