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Bill - I've added this section to guide nonclinical in vitro data generation.  How do we introduce the relref dataset here?


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 RE domain contains dynamic measurements, collected or derived, related to the respiratory system.
  2. The actual timing variables REDTC, REENDTC, REDY and REENDY are used to represent the start and end of the evaluation period during which data that contributed to the reported result were collected. This may be a portion of a longer period over which the instrument was continuously collecting data.
  3. RESTINT and REENINT should be used to describe a known assessment interval whenever there is a reference time point (RETPTREF).
  4. REMETHOD and RECSTATE are considered important for comparison purposes and should be populated whenever available or collected.

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