SDTMIG v3.2

Published Date: 26 November 2013

SDTMIG v3.2 is the implementation guide for Human Clinical Trials and corresponds with SDTM v1.4. SDTMIG v3.2 includes eleven additional domains: EC, PR, HO, DD, IS, MI, MO, RP, SR, SS, and TD. All previous annotations in SDTMIG 3.1.3, published in 2012, have been incorporated in SDTMIG v3.2.

Files

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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.

Overall: Intra-document cross-references should be changed from bold italic to plain text.

Section 2 - Fundamentals of the SDTM

Section 2.6, step 2: The extraneous H in front of the URL should be deleted.
Section 2.7:
- The title of this section should be renamed from "SDTM variables Allowed in SDTMIG" to "SDTM Variables Not Allowed in SDTMIG".
- The text in parentheses after --DETECT should be changed from "Findings" to "Timing".

Section 3 - Submitting Data in Standard Format

Section 3.1:
- The fifth item in the first bulleted list (which starts, "The origin or source...") should be deleted.
- In the paragraph preceding the second bulleted list, in the phrase "the CDISC domain models include three other shaded columns...", the word "three" should be changed to "two".
- The third (and final) item in the second bulleted list should be deleted.

Section 4 - Assumptions For Domain Models

Section 4.1.4.7, Examples of --STRTPT, --STTPT, --ENRTPT, and --ENTPT, 2. Adverse Events: The final line of this example, "AEENRTPT = "U" ", should be followed by an additional line that reads: "AEENTPT = final subject contact date, e.g., "2006-11-02" "

Alternate description:
Section 4.1.4.8: The title of this section should be changed from "AEENTPT = final subject contact date, e.g., "2006-11-02"Date and Time Reported in a Domain Based on Findings" to "Date and Time Reported in a Domain Based on Findings"
Section 4.1.4.10, second table: The value in for LBDTC in Row 1 should be changed from "2006-08-01T08:30" to "2006-08-01T07:45".

Section 5 - DM Domain

DM – Specification for the Demographics Domain Model: The value in the "Variable Label" column for ACTARM should be "Description of Actual Arm".
DM – Examples for the Demographics Domain Model, Example 1: The values in the "SUBJID" column should be changed for each row as follows:
- Row 1: "001" should be changed to "01001"
- Row 2: "002" should be changed to "01002"
- Row 3: "003" should be changed to "01003"
- Row 4: "004" should be changed to "01004"
- Row 5: "001" should be changed to "02001"
- Row 6: "002" should be changed to "02002"

Section 5 - SE Domain

SE – Specification for the for the Subject Elements Domain Model: TAETORD and EPOCH should come before SESTDTC in the table.
Example 1, dm.xpt, Variable BIRTHDTC should be BRTHDTC.
Example 2, dm.xpt, Variable BIRTHDTC should be BRTHDTC.

Section 6.1 - EX and EC Domains

EX-EC – Examples for Exposure and Exposure as Collected Domain Models, Example 7, ec.xpt:
- EXSTDY should be changed to ECSTDY
- EXENDY should be changed to ECENDY
- In row 4, the value for ECADJ should be "Injection Site Reaction".

Section 6.2 - AE Domain

6.3 Events: The numbering for this section heading should be changed to 6.2. In the portfolio edition, the corresponding bookmark should be changed likewise.

Section 6.2 - MH Domain

MH - Specification for Medical History Domain Model: The value in the "Role" column for MHPRESP should be changed from "Variable Qualifier of --TERM" to "Variable Qualifier".

Section 6.3 Index

TU, TR, and RS: "Disease Response (SR)" should be changed to "Disease Response (RS)".

Section 6.3 - EG Domain

EG - Specification for ECG Test Results Domain Model: "EGFXN" should be changed to "EGXFN".
EG - Specification for ECG Test Results Domain Model: The value in the "Controlled Terms, Codelist or Format" column for EGLEAD should be "( EGLEAD )".

Section 6.3 - IS Domain

IS – Specification for the Immunogenicity Specimen Assessment Domain Model:
- The value in the "Type" column for ISSEQ should be "Num".
- The value in the "Type" column for ISGRPID should be "Char".
- The value in the "Role" column for ISTESTCD should be "Topic"
- The value in the "Role" column for ISTEST should be "Synonym Qualifier"

Section 6.3 - LB Domain

LB - Examples for Laboratory Test Results Domain Model: The word "Laboratory" in the title of this section should match the font size of the rest of the title.

Section 6.3 - TU TR and RS Domains

TU – Examples for Tumor Identification Domain Model, Example 1:
- The title of this example should be changed from "TU Example 1" to "Example 1".
- The text between the second and third tables should be changed from "SUPPTU for Example 1:" to "supptu.xpt" and italicized; the blank line between it and the table following should be removed.
- The third table should repeat the heading row after the page break.
TU – Examples for Tumor Identification Domain Model, Example 2:
- The title of this example should be changed from "TU Example 2" to "Example 2".
- The space between tables should be reduced from two blank lines to one blank line.

Section 6.4 - FA Domain

Every instance of "Findings About" that is not immediately followed by "Events or Interventions" (except in variable labels) should be changed to "Findings About Events or Interventions".
FA – Specification for Findings About Domain Model: In the title of the specification table (the text in bold immediately between the section title and the table), the version number should be changed from "3.1.2" to "3.2".
FA - Examples for Findings About Domain Model, Example 6, first table: The first row of this table should be moved to join the rest of the table on the second page.
FA - Examples for Findings About Domain Model, Example 6, fa.xpt: The second table should repeat the heading row after the page break.
FA - Examples for Findings About Domain Model, Example 8, ae.xpt: The title and first row of this table should be moved to join the rest of the table on the second page.

Section 6.4 - SR Domain

SR – Specification for Skin Response Domain Model: In the title of the specification table (the text in bold immediately between the section title and the table), "SR.xpt" should be changed to "sr.xpt" and the class should be changed from "Findings" to "Findings Sub-Class".

Section 7.4 - Trial Summary And Eligibility

TI – Specification for Trial Inclusion/Exclusion Criteria Dataset:
- The "I" of "TI" in this section heading should be capitalized.
- The value in the "Variable Label" column for IETESTCD should be changed from "Incl/Excl Criterion Short Name e" to "Inclusion/Exclusion Criterion Short Name".
TS – Examples for Trial Summary Information Dataset, Example 1: The value for TSVCDREF in row 27 should be changed from "EUDRAC" to "EUDRACT".

Section 8 - Representing Relationships and Data

In the last sentence of the first paragraph, "(when QORIG=”ASSIGNED”)" should be changed to "(when QORIG=”Assigned”)".
8.4.1 Supplemental Qualifiers: SUPP-- Datasets, QORIG, CDISC Notes: "Examples include CRF, ASSIGNED, or DERIVED." should be changed to "Examples include "CRF", "Assigned", or "Derived"."
8.4.3 SUPP-- Examples, Example 1, suppdm.xpt: The value for QORIG in both rows should be changed from "DERIVED" to "Derived".
8.4.3 SUPP-- Examples, Example 2, suppae.xpt: The value for QORIG in Row 2 should be changed from "DERIVED" to "Derived".

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	Variable Labels more than 40 characters
Affected Standard	SDTMIG v3.2
Description of Error	Variable labels listed below are more than 40 characters, but 40 characters is the maximum length of a label in the SAS v5 transport format required by regulators
Efforts to Correct Error	Variable labels no more than 40 characters in length are included in SDTMIG v3.3.

Concerned Published Element	Concerned Published Attribute	Published Attribute Value
HO.HOTERM	Label	Reported Term for the Healthcare Encounter
HO.HODECOD	Label	Dictionary-Derived Term for the Healthcare Encounter
HO.HOSTDY	Label	Study Day of Start of Healthcare Encounter
MH.MHREASND	Label	Reason Medical History Not Done or Not Occurred
IS.ISSTRESC	Label	Character Results/Findings in Standard Format
MI.MISTRESC	Label	Character Result/Finding in Standard Format
PC.PCSTRESC	Label	Character Result/Finding in Standard Format
PP.PPSTRESC	Label	Character Result/Finding in Standard Format
PE.PESTRESC	Label	Character Result/Finding in Standard Format
QS.QSSTRESC	Label	Character Result/Finding in Standard Format
SR.SRSTRESC	Label	Character Results/Findings in Standard Format
FA.FALAT	Label	Laterality of Location of the Finding About

Impact of Issue	Coping Strategy
Labels published in the SDTMIG v3.2 for these variables cannot be used.	Use a label no more than 40 characters in length, such as the label in SDTMIG v3.3.
Validation software may return errors or warnings for labels for these variables, since no label 40 or fewer characters long matches the label for the variable in the SDTMIG v3.2.	Explain any validation errors or warnings in the Clinical Study Data Reviewers Guide (cSDRG).

A known issue is a problem or concern with a CDISC standard that CDISC is aware of, and may be working actively to mitigate or resolve. Unlike errors or errors that affect conformance, known issues have no obvious solution when they are first identified; and some known issues may prove to be irresolvable.

Short Name	Type mismatch for ECDOSTOT
Affected Standard	SDTMIG v3.2
Description of Error	The SDTMIG v3.2 indicates the Type for the ECDOSTOT variables is "Char". However, the correct Type as prescribed by the SDTM is "Num".
Efforts to Correct Error	In SDTMIG v3.3, the Type of ECDOSTOT was updated to be "Num" for consistency with the SDTM.

Concerned Published Element	Concerned Published Attribute	Published Attribute Value	Revised Attribute Value
EC.ECDOSTOT	Type	Char	Num

Impact of Issue	Coping Strategy
Data preparers who use the revised Type, "Num" may see validation errors or warnings.	Explain any validation errors or warnings in the Clinical Study Data Reviewers Guide (cSDRG).
Submissions which use the published Type, "Char" and include non-numeric values for ECDOSTOT may result in errors in analysis programs which expect numeric values.	Limit ECDOSTOT values to numeric values.

Short Name	"COUNTRY" Terminology Change
Affected Standard	SDTMIG v3.1.2 SDTMIG v3.1.2, Amendment 1 SDTMIG v3.1.3 SDTMIG v3.2
Description of Codelist Change	The SDTMIG v3.2 and earlier versions list the CDISC SDTM codelist "COUNTRY" as the terminology codelist to use for the Demographics domain variable COUNTRY. This codelist was retired in 2016-09-30 (Package 27) because it duplicated the ISO 3166-1 alpha-3 codes for the representation of names of countries and their subdivisions. Maintaining the SDTM "COUNTRY" codelist was not reasonable, since it duplicated content maintained by ISO.
Standard with Codelist Change	SDTMIG v3.3 lists 3166-1 alpha-3 as the codelist for the COUNTRY variable

Affected Variable	Codelist in Published Standard	Replacement Codelist
DM.COUNTRY	CDISC codelist "COUNTRY"	ISO 3166-1 alpha-3

Impact of Issue	Coping Strategy
For submissions using CDISC CT package 27 or later, the CDISC SDTM "COUNTRY" codelist is not present.	Use ISO 3166-1 alpha-3. Click the online browser link from https://www.iso.org/iso-3166-country-codes.html
For submissions using CDISC CT package 27 or later, submission values that were prepared using the CDISC SDTM "COUNTRY" codelist for DM.COUNTRY may not be those in the current version of ISO 3166-1 alpha-3	Most values will be identical, but should be checked.

Short Name	Codelists for FA Test Names and Test Codes
Affected Standard	SDTMIG v3.2
Description of Codelist Change	The domain specification specifies a codelist "FATEST" for the variable FATEST and a codelist "FATESTCD" for the variable "FATESTCD". However, the FATEST and FATESTCD codelists were removed in the 2016-09-30 version of the SDTM Controlled Terminology. In that and later releases of controlled terminology, therapeutic area-based codelists for the variables FATEST and FATESTCD were included.
Standard with Codelist Change	The SDTMIG v3.3 indicates, with an asterisk, that for FATEST and FATESTCD, "the variable may be subject to controlled terminology." (Versions of the SDTMIG before v3.2 also included an asterisk for these variables.) In SDTMIG v3.3, the CDISC Notes for FATEST and FATESTCD include include the statement, "Note that controlled terminology is in several therapeutic area-specific codelists."

Affected Variable	Codelist in Published Standard	Replacement Codelist
FA.FATEST	CDISC Codelist "FATEST"	One of several codelists with names formatted as "Findings about <therapeutic area> Test Name
FA.FATESTCD	CDISC Codelist "FATESTCD"	One of several codelists with names formatted as "Findings about <therapeutic area> Test Code"

Impact of Issue	Coping Strategy
For submissions prepared using SDTMIG v3.2 that use the 2016-09-30 or later releases of CDISC CT,the "FATEST" and "FATESTCD" codelists are not present in CDISC CT.	Use values in therapeutic area-specific test name and test code lists, where applicable.
Therapeutic area-specific test name and test code lists may not exist for the therapeutic area of a study.	Use values from therapeutic area-specific test name and test code lists, where the definition fits the data collected, even if the study is in a different therapeutic area. Note that the Define-XML document can list only one codelist for a variable, so if terminology is drawn from more than one codelist, the sponsor would have to choose one CDISC codelist and treat values not in that published codelist as extended values, or treat the codelist as a sponsor-defined codelist.

Impact of Issue

Coping Strategy

For submissions prepared using SDTMIG v3.2 that use the 2016-09-30 or later releases of CDISC CT,the "FATEST" and "FATESTCD" codelists are not present in CDISC CT.

Use values in therapeutic area-specific test name and test code lists, where applicable.

Therapeutic area-specific test name and test code lists may not exist for the therapeutic area of a study.

Use values from therapeutic area-specific test name and test code lists, where the definition fits the data collected, even if the study is in a different therapeutic area. Note that the Define-XML document can list only one codelist for a variable, so if terminology is drawn from more than one codelist, the sponsor would have to choose one CDISC codelist and treat values not in that published codelist as extended values, or treat the codelist as a sponsor-defined codelist.

Short Name	TSPARM "Pharmacological Class" Terminology Change
Affected Standard	SDTMIG v3.1.3 SDTMIG v3.2
Description of Codelist Change	The SDTMIG, in an appendix and in a Trial Summary (TS) Example, "NDF-RT" is given as the terminology to be used for TSVAL when TSPARMCD = "PCLAS". "NDF-RT" stands for "National Drug File - Reference Terminology", It has been replaced by "MED-RT" or "Medication Reference Terminology" as explained here https://evs.nci.nih.gov/ftp1/MED-RT/Introduction%20to%20MED-RT.pdf . The FDA Data Standards Catalog, 2018-12-19 and later versions, specified "MED-RT" as the terminology to be used for TSVAL when TSPARMCD = "PCLAS".
Standard with Codelist Change	The codelist was corrected in SDTMIG v3.3.

Affected Variable	Codelist in Published Standard	Replacement Codelist
TS.TSVAL when TS.TSPARMCD = "PCLAS"	NDF-RT	MED-RT

Impact of Issue	Coping Strategy
For data that has not been coded, the NDF-RT codelist is no longer available.	Use the MED-RT codelist instead.
Data values taken from the NDF-RT codelist may not be present in the MED-RF codelist.	Most code values are probably the same, but should be checked.

Short Name	Codelist for ECMOOD Variable
Affected Standard	SDTMIG v3.2
Description of Codelist Change	In SDTMIG v3.2, no codelist is listed for use with the Exposure as Collected variable ECMOOD, although the CDISC Notes list "SCHEDULED" and "PERFORMED" as example values. The CDISC codelist "BRDGMOOD", which has those two values, was introduced in 2016-03-25 (Package 25).
Standard with Codelist Change	SDTMIG v3.3 specifies the "BRIDGMOOD" codelist for use with the ECMOOD variable.

Affected Variable	Codelist in Published Standard	Replacement Codelist
EC.ECMOOD	None.	CDISC Codelist "BRDGMOOD"

Impact of Issue	Coping Strategy
Submissions using Package xx or later should use the codelist "BRIDGMOOD" for values of EC.ECMOOD.	Check that submission values are those in the "BRIDGMOOD" codelist.

SDTMIG v3.2

Files

Errata

SDTMIG v3.2

Section 2 - Fundamentals of the SDTM

Section 3 - Submitting Data in Standard Format

Section 4 - Assumptions For Domain Models

Section 5 - DM Domain

Section 5 - SE Domain

Section 6.1 - EX and EC Domains

Section 6.2 - AE Domain

Section 6.2 - MH Domain

Section 6.3 Index

Section 6.3 - EG Domain

Section 6.3 - IS Domain

Section 6.3 - LB Domain

Section 6.3 - TU TR and RS Domains

Section 6.4 - FA Domain

Section 6.4 - SR Domain

Section 7.4 - Trial Summary And Eligibility

Section 8 - Representing Relationships and Data

Errors that Affect Conformance

Variable Labels more than 40 characters

Type mismatch for ECDOSTOT

"COUNTRY" Terminology Change

Codelists for FA Test Names and Test Codes

TSPARM "Pharmacological Class" Terminology Change

Codelist for ECMOOD Variable