SENDIG v3.0

Published Date: 17 June 2011

Version 3.0 of SENDIG is intended to guide the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to regulatory authorities. Version 3.0 of the SENDIG is designed to support single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. The SENDIG is based on, and should be used in close concert with, SDTM v1.2.

For a better understanding of the study endpoints that can be confidently exchanged using the SENDIG v3.0, the SEND development team released a supplemental document, Confirmed Data Endpoints for SENDIG v3.0 Data Exchange (CoDEx 1.0 for SEND v3.0) on 16 Aug 2017.

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Errors that Affect Conformance

An error that affects conformance is a correction to a mistake in the normative content of a CDISC standard, which was identified after the standard has been published on the CDISC website, and which would have been corrected in the current version had it been identified prior to publication. Corrections that require a cycle through the Standards Development Process are not considered errors that affect conformance. Corrections to errors that do not impact conformance to CDISC standards are listed as Errata.

Short Name	Type mismatch for LBORNRLO and LBORNRHI
Affected Standard	SENDIG v3.0
Description of Error	The SENDIG v3.0 indicates the Type for the LBORNRLO and LBORNRHI variables is "Num". However, the correct Type as prescribed by the SDTM is "Char".
Efforts to Correct Error	In SENDIG v3.1, the Type of these variables was updated to be 'Char' for consistency with the SDTM.

Concerned Published Element	Concerned Published Attribute	Published Attribute Value	Revised Attribute Value
LB.LBORNRLO	Type	Num	Char
LB.LBORNRHI	Type	Num	Char

Impact of Issue	Coping Strategy
Both presentations are being used for SEND v3.0 datasets across the industry, some choosing to match the SENDIG V3.0 and others to match the SDTM.	Data receivers may expect to receive the data types for LBORNRLO and LBORNRHI as either "Num" or "Char".
Data preparers who use data type of "Num" for LBORNRLO and LBORNRHI may see validation errors or warnings.	Data preparers who use data type of "Num" for LBORNRLO and LBORNRHI should be prepared to explain the reason for the validation errors or warnings in the Non-clinical Study Data Reviewers Guide (nSDRG).

SENDIG v3.0

Files

Errors that Affect Conformance

Type mismatch for LBORNRLO and LBORNRHI