SDTMIG v3.4

Published Date: 29 November 2021

Version 3.4 of the Study Data Tabulation Model Implementation Guide (SDTMIG): Human Clinical Trials is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets may be used for various purposes, including publication, warehousing, meta-analyses, and regulatory submission. It should be used in close concert with SDTM v2.0.

SDTMIG v3.4 provides specific domain models, assumptions, business rules, and examples for preparing standard tabulation datasets that are based on the SDTM.

Noteworthy changes from the previous version (SDTMIG v3.3) include:

The Subject Visits (SV) domain includes additional variables and contains information for each subject's actual and planned visits.
Addition of two new domains: Genomics Findings (GF) and Cell Phenotype Findings (CP). GF is a findings domain that contains data related to the structure, function, evolution, mapping, and editing of subject and non-host organism genomic material of interest. CP is also a findings domain that contains data related to the characterization of cell phenotype, lineage, and function based on expression of specific markers in single cell or particle suspensions.
The Morphology (MO) domain has been decommissioned.
Biospecimen Events (BE), Biospecimen Findings (BS), and Related Specimens (RELSPEC) have been copied from SDTMIG-PGx v1.0, which has been deprecated with the publication of SDTMIG v3.4.

SDTMIG v3.4 supersedes all prior versions of the SDTMIG. Please visit Appendix E for an overview of all changes to the SDTMIG since SDTMIG v3.3.

Public Review Comments

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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 1.5 - Known Issues

The issue "Use of --LNKID and --LNKGRP" has text that reads, "...; a row where RELTYPE = MANY will have an IDVAR of --LNKID (and not --LNKGRP).", but should be, "... ; a row where RELTYPE = MANY will have an IDVAR of --LNKGRP (and not --LNKID)."

Section 3 - Submitting Data in Standard Format

Section 3.2.1 - Dataset-Level Metadata
- In the row of the table for the SV dataset, the value given for Keys is "STUDYID, USUBJID, SVTERM" but should be "STUDYID, USUBJID, VISITNUM".
- UR metadata row, in the column “Structure”, "per per" should be changed to "per".

Section 5.3 - SE Domain

Example 1, dm.xpt, Variable BIRTHDTC should be BRTHDTC.
Example 2, dm.xpt, Variable BIRTHDTC should be BRTHDTC.

Section 6.3.7.8 Urinary System Findings

UR - Specifications: In the table title, "per per" should be changed to "per".

Section 8.4.3, Trial Summary

--SUPP Examples, Example 1, suppae.xpt: The value for QEVAL in Row 2 should be changed from "SPONSOR" to null.

The roles of some variables in domain specifications did not match the roles of the root variable in SDTM v2.0:

The role of SUDOSFRQ was given as "Variable Qualifier" but should have been "Record Qualifier".
The role of AGROUTE was given as "Variable Qualifier" but should have been "Record Qualifier".
The role of ECROUTE was given as "Variable Qualifier" but should have been "Record Qualifier".
The role of EXROUTE was given as "Variable Qualifier" but should have been "Record Qualifier".
The role of PRROUTE was given as "Variable Qualifier" but should have been "Record Qualifier".
The role of SUROUTE was given as "Variable Qualifier" but should have been "Record Qualifier".
The role of MSAGENT was given as "Variable Qualifier" but should have been "Record Qualifier".
The role of BEPRTYID was given as "Record Qualifier" but should have been "Variable Qualifier".
The role of CPBDAGNT was given as "Record Qualifier" but should have been "Variable Qualifier".
The role of CPCOLSRT was given as "Record Qualifier" but should have been "Variable Qualifier".
The role of LBCOLSRT was given as "Record Qualifier" but should have been "Variable Qualifier".
The role of COEVALID was given as "Record Qualifier" but should have been "Variable Qualifier".
The role of CPLOINC was given as "Synonym Qualifier" but should have been "Record Qualifier".
The role of LBLOINC was given as "Synonym Qualifier" but should have been "Record Qualifier".
The role of MBLOINC was given as "Synonym Qualifier" but should have been "Record Qualifier".
The role of MSLOINC was given as "Synonym Qualifier" but should have been "Record Qualifier".
The role of VSLAT was given as "Result Qualifier" but should have been "Record Qualifier".