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This page contains the working list of errata for the final version 3.1 of the SENDIG.

Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies v3.1

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.

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.

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…"

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.”

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...”


This page is under construction. It will contain the known issues for SEND IG V3.1 after adjudication by the SEND Team CCB (Change Control Board). Comments, questions, and issues to be considered can come from many sources, including: [PhUSE SEND Implementation working group], the [CDISC Discussion Forum], individual SEND Core Team members, anyone with CDISC Wiki access via JIRA change entry assigned to the SEND project.