CDISC SDTM 3.1.1

Purpose

CDISC SDTM defines a standard structure for data tabulations that are submitted as part of a product application to a regulatory authority such as the FDA. The data sets and columns required for a regulatory application are not prescribed by the standard. Instead, these requirements are based on the trial protocol and discussions with the regulatory authority in charge of reviewing the submission. Therefore, any SAS Clinical Standards Toolkit standard, including any CDISC SDTM standard, is only a representative sample or template.

Release Dates

CDISC SDTM 3.1.1

CDISC SDTM Model, Final Version 1.1, May 4, 2005
CDISC SDTM Implementation Guide, Final Version 3.1.1, September 8, 2005

CDISC SDTM 3.1.2

CDISC SDTM Model, Final Version 1.2, November 12, 2008
CDISC SDTM Implementation Guide, Final Version 3.1.2, November 12, 2008

CDISC SDTM 3.1.1 Reference Standard

The CDISC SDTM 3.1.1 SAS Clinical Standards Toolkit reference standard includes the following 25 domains:

CDISC SDTM 3.1.1 Reference Standard Domains

CDISC SDTM 3.1.1 Domains
Special Purpose Domains	Events
Demographics-DM	Adverse Events-AE
Comments-CO	Disposition-DS
	Medical History-MH
Interventions	Protocol Deviations-DV
Concomitant Medications-CM
Exposure-EX	Trial Design Domains
Substance Use-SU	Trial Elements-TE
	Trial Arms-TA
	Trial Visits-TV
Findings	Subject Elements-SE
ECG Tests-EG	Subject Visits-SV
Inclusion/Exclusion Exceptions-IE	Trial Inclusion/Exclusion Criteria-TI
Laboratory Tests-LB	Trial Summary-TS
Questionnaires-QS
Physical Examinations-PE	Special Purpose Relationship Data Sets
Subject Characteristics-SC	Supplemental Qualifiers-SUPPQUAL
Vital Signs-VS	Related Records-RELREC

Within these 25 domains, 495 columns have been defined.

Description

CDISC standards allow for the inclusion and exclusion of some columns. (For example, timing variables can be included or excluded.) In addition, CDISC standards do not specify a length for most columns. Therefore, any implementation of a CDISC standard requires interpretation of that standard. This interpretation might lead to differences in the implementation of that standard. Reference standards are derived based on internal conventions and experiences, and discussions with regulatory authorities.

The domain and column metadata that constitute the SAS representation of CDISC SDTM 3.1.1 are derived from the global standards library in these formats:

as empty data sets (using the utility macro cst_createTablesForDataStandard)
as table metadata (reference_tables in the standard metadata folder)
as column metadata for each domain (reference_columns in the standard metadata folder)

The SAS Clinical Standards Toolkit CDISC SDTM reference standard provides metadata and code to validate the structure and content of the SDTM domains. To enable validation, supplemental files supporting SDTM validation processes include the following global standards library files:

The Validation Master data set in the validation/control folder contains the super-set of checks validating domain structure and content.
The Messages data set in the messages folder provides error messaging for all Validation Master checks.
SAS code in the macros folder provides code specific to SDTM that augments code that is provided in the primary SAS Clinical Standards Toolkit autocall library (!sasroot/cstframework/sasmacro).

It is this set of files, in whole or in part, that defines the CDISC SDTM reference standard.

CDISC SDTM 3.1.2 Reference Standard

The CDISC SDTM 3.1.2 SAS Clinical Standards Toolkit reference standard includes the following 32 domains:

CDISC SDTM 3.1.2 Reference Standard Domains

CDISC SDTM 3.1.2 Domains
Special Purpose Domains	Events
Demographics-DM	Adverse Events-AE
Comments-CO	Clinical Events-CE
Subject Elements-SE	Disposition-DS
Subject Visits-SV	Protocol Deviations-DV
	Medical History-MH
Findings
Drug Accountability-DA	Interventions
ECG Tests-EG	Concomitant Medications-CM
Inclusion/Exclusion Criterion Not Met-IE	Exposure-EX
Laboratory Test Results-LB	Substance Use-SU
Microbiology Specimen-MB
Microbiology Susceptibility Test-MS	Trial Design Domains
PK Concentrations-PC	Trial Arms-TA
Physical Examinations-PE	Trial Elements-TE
PK Parameters-PP	Trial Inclusion/Exclusion Criteria-TI
Questionnaires-QS	Trial Summary-TS
Subject Characteristics-SC	Trial Visits-TV
Vital Signs-VS
	Relationship Data Sets
Findings About	Supplemental Qualifiers-SUPPQUAL
Findings About-FA	Related Records-RELREC

Within these 32 domains, 723 columns have been defined.

Description

CDISC standards allow for the inclusion and exclusion of some columns. (For example, timing variables can be included or excluded.) CDISC standards do not specify a length for most columns. Therefore, any implementation of a CDISC standard requires interpretation of that standard. This interpretation might lead to differences in the implementation of that standard. Reference standards are derived based on internal conventions and experiences, and discussions with regulatory authorities.

The domain and column metadata that constitute the SAS representation of CDISC SDTM 3.1.2 are derived from the global standards library in the following formats:

as empty data sets (using the utility macro cst_createTablesForDataStandard)
as table metadata (reference_tables in the standard metadata folder (see the example in the following table))
as column metadata for each domain (reference_columns in the standard metadata folder (see the example in Sample Reference_Columns Record (CDISC SDTM 3.1.2)))

Sample Reference_Tables Record (CDISC SDTM 3.1.2)

Column Name	Column Value
sasref	REFDATA
table	CE
label	Clinical Events
class	Events
xmlpath	.../transport/ce.xpt
xmltitle	Clinical Events SAS transport file
structure	One record per event per subject
purpose	Tabulation
keys	STUDYID USUBJID CETERM CESTDTC
state	Final
date	November 12, 2008
standard	CDISC-SDTM
standardversion	3.1.2
standardref
comment

Sample Reference_Columns Record (CDISC SDTM 3.1.2)

Column Name	Column Value
sasref	REFDATA
table	SU
column	SUSTRF
label	Start Relative to Reference Period
order	32
type	C
length	20
displayformat
xmldatatype	text
xmlcodelist	STENRF
core	Perm
origin	Derived
role	Timing
term	** BEFORE, DURING, AFTER
algorithm
qualifiers	UPPERCASE
standard	CDISC-SDTM
standardversion	3.1.2
standardref	SDTMIG4.1.4.7
comment	Identifies the start of the substance use period with respect to the sponsor-defined reference period. Sponsors should define the reference period in the study metadata. SUSTRF should be populated when a start date is not collected. If information such as PRIOR, ONGOING, or CONTINUING was collected, then this information should be translated into SUSTRF.

The SAS Clinical Standards Toolkit CDISC SDTM reference standard provides metadata and code to validate the structure and content of the SDTM domains. To enable validation, supplemental files supporting SDTM validation processes include the following global standards library files:

The Validation Master data set in the validation/control folder contains the super-set of checks validating domain structure and content.
The Messages data set in the messages folder provides error messaging for all Validation Master checks.
SAS code in the macros folder provides code specific to SDTM that augments code that is provided in the primary SAS Clinical Standards Toolkit autocall library (!sasroot/cstframework/sasmacro).

It is this set of files, in whole or in part, that defines each CDISC SDTM reference standard.