SENDIG v3.1

Published Date: 27 June 2016

SENDIG v3.1 is intended to guide the organization, structure, and format of standard non-clinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to regulatory authorities. The SENDIG v3.1 is based on, and should be used in close concert with, SDTM v1.5, which is included in the document package.

Significant changes since v3.0 include:

The variable VISITDY has been reclassified from Expected to Permissible, and three new variables were added to relevant domains (--USCHFL, --NOMLBL, --NOMDY). VISITDY will be phased out of the SENDIG over time. An explanation of these changes and how they will develop over time is in Section 4.4.
Two new domains for Safety Pharmacology studies have been added: Cardiovascular (CV) and Respiratory (RE); Vital Signs domain has been updated.
New FOCID variable added to several domains (EX, CL, MA, and MI). FOCID is available to all general observation classes to specify a study-specific point of interest.
Microscopic Findings domain updated, added three new variables (FOCID, --CHRON, --DISTR).
Updated ECG Test Results domain, added two new Timing variables (--STINT and –ENINT).

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.

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Errata

An erratum (plural: errata) is a correction to a mistake made in a published standard, which was identified after it was published on the CDISC website, and which would have been corrected in the current version had it been identified prior to publication. Updates, revisions, substantive corrections, and other changes of enough significance to require a cycle through the Standards Development Process are not errata, and thus are not included on the pages below.

Section 3 Using SEND in the Context of a Data Exchange Package

Page 13 / Section 3.2.1, Table 3.2.1:
- The values in the class column should use the SDTM General Observation Class codelist.

Section 5 Models for Special-Purpose Domains

Page 43 / Section 5.1.1, Demographics – DM:
- In the first sentence of the CDISC notes for SBSTRAIN, change "qualifiying" to “qualifying.”
Page 49 / Section 5.3.1, Subject Elements – SE:
- In the CDISC notes for ELEMENT, remove the extra period at the end of the sentence.

Section 6 Domain Models Based on the General Observation Classes

Page 53 / Section 6.1.1, Exposure – EX:
- In the CDISC notes for FOCID, the last sentence, “the value in this variable should have inherent…” should be changed to “The value in this variable should have inherent…”
Page 69 / Section 6.3.3, Clinical Observations – CL:
- In the CDISC notes for FOCID, the last sentence, “the value in this variable should have inherent…” should be changed to “The value in this variable should have inherent…”
Page 94 / Section 6.3.6.2, Examples for Laboratory Test Results (LB) Domain Model, LB Example 2:
- Add a “T” following the “P” in the results for the LBELTM column to conform to ISO 8601 standards.
Page 96 / Section 6.3.7, Macroscopic Findings – MA:
- In the CDISC notes for FOCID, the last sentence, “the value in this variable should have inherent…” should be changed to “The value in this variable should have inherent…”
Page 98 / Section 6.3.7.1, Assumptions for Macroscopic Findings (MA) Domain Model, Item 4b:
- The last sentence the first word should be capitalized. Change “the” to “The.”
Page 102-103 / Section 6.3.8, Microscopic Findings – MI:
- In the CDISC notes for FOCID, the last sentence, “the value in this variable should have inherent…” should be changed to “The value in this variable should have inherent…”
- In the CDISC notes for MISPEC, fix the spelling of “orgain” to “organ.”
Page 111 / Section 6.3.9, Organ Measurements – OM
- In the CDISC notes for OMSPEC, change “Examples: GLAND, ADRENAL, KIDNEY, VESSEL, LYMPHATIC.” to “Examples: GLAND, ADRENAL; KIDNEY; VESSEL, LYMPHATIC.
Page 150 / Section 6.3.15, Vital Signs – VS:
- The Controlled Terms, Codelist, or Format for VSTESTCD should be changed from “SVSTSTCD” to “VSTESTCD.”
- The Controlled Terms, Codelist, or Format for VSTEST should be changed from “SVSTST” to “VSTEST.”
Page 164 / Section 6.3.17, Cardiovascular Test Results – CV
- In the CDISC notes for CVNOMLBL, there is a period missing, change "….in the study report Examples:…" to “…in the study report. Examples:…"
Page 168 / Section 6.3.18, Respiratory Test Results – RE
- In the CDISC notes for REPOS, the end of first sentence should have a period instead of a comma. Change "….or examination, If the subject….." to "….or examination. If the subject…"

Section 7 Trial Design Model Datasets

Pages 208-209 / Section 7.6.2, Trial Summary Examples, Examples 1 and 2:
- Change “SEND Implementation Guide Version 3.0” to “SEND IMPLEMENTATION GUIDE VERSION 3.1.”

Section 8 Representing Relationships and Data

Page 219 / Section 8.2, Relating Records - RELREC:
- In the CDISC notes for RELID, change the second sentence of the CDISC notes from “RELID can be any value the sponsor chooses and is only meaningful within the df dataset….” to “RELID can be any value the sponsor chooses and is only meaningful within the RELREC dataset…”
Page 224 / Section 8.3, Supplemental Qualifiers: SUPP-- Datasets:
- In the first sentence of the CDISC notes for POOLID, remove the extra period at the end of the sentence.
Page 227 / Section 8.5.1, Pool Definition - POOLDEF:
- In the CDISC notes for USUBJID, the words "a subject" are missing. Change “Identifier used to uniquely identify across all studies....” to “Identifier used to uniquely identify a subject across all studies...”