Description

A relationship dataset used to describe how information is related to the design of the study and to other sources of information within the study.

relref.xpt, Related References — Relationship. One record per Reference ID, 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

STUDYIDStudy IdentifierChar


Identifier

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

Req

SETCDTrial Set CodeChar


Identifier

The short sequence of characters used to represent the trial set.

Req

REFIDReference IDChar


IdentifierA sequence of characters used to uniquely identify a source of information.

Req

PARENT

Parent Reference ID

Char


Identifier

The identifier for the immediate progenitor of a source of information. Identifies the REFID of the parent.

Exp

LEVEL

Reference ID Generation Level

Num


Variable Qualifier

The generation number of the information source in relation to the first generation of the source of information. Identifies the level number of the reference ID.

Exp

LVLDESC

Reference ID Level Description

Char

(LVLDSCRS)

Variable Qualifier

A description of the generation number of the information source in relation to the first generation of the source of information. Examples: ASSAY, TRIAL SET, EXPERIMENTAL UNIT, OBSERVATIONAL UNIT.

Perm


Assumptions

  1. The Related References domain (RELREF) is a relationship dataset used to describe how information is related to the design of the study and to other sources of information within the study.
  2. To identify a source of information from a genetic toxicology assay within a study, a unique identifier (REFID) must be assigned and populated in all datasets containing the REFID column. In other words, each GTREFID that exists in the GT dataset must exist in the RELREF dataset.
  3. Each REFID that exists in the RELREF dataset must exist in the GT dataset. 
  4. For each value in PARENT there must exist one record with REFID value = PARENT value. The value of REFID must be unique in the RELREF dataset.
  5. The value for LEVEL must be 1 for a record without a PARENT record.  This record may or may not have a child record.
  6. If a record has a PARENT, LEVEL must be populated with a LEVEL that is sequentially one greater than the PARENT record (e.g., value for LEVEL = value for PARENT LEVEL + 1).

« SEND Related Records (RELREC)

SEND Respiratory Test Results (RE) »

  • No labels