SDTM Domain Structure

Serial No	CDISC Domain Code	Dataset	Description	Definition	Class	Structure	Purpose	Keys*	Topic variables	Identifier variables	Timing variables	Qualifier variables	Rule Variables
		DM	Demographics	The Demographics domain includes a set of essential standard variables that describe each subject in a clinical study. It is the parent domain for all other observations for human clinical subjects.	Special Purpose Domains	One record per subject	Tabulation	STUDYID, USUBJID	SUBJID -          Study Identifier for the study	STUDYID DOMAIN USUBJID	DMDTC DMDY	RFSTDTC RFENDTC RFXSTDTC RFXENDTC RFICDTC RFPENDTC DTHDTC DTHFL SITEID INVID INVNAM BRTHDTC AGE AGEU SEX RACE ETHNIC ARMCD ARM ACTARMCD ACTARM COUNTRY
		CO	Comments	The Comments dataset accommodates two sources of comments: 1) those collected alongside other data on topical case report form (CRF) pages such as Adverse Events and 2) those collected on a separate page specifically dedicated to comments.	Special Purpose Domains	One record per comment per subject	Tabulation	STUDYID, USUBJID, COSEQ	COVAL -Comments	STUDYID DOMAIN USUBJID COSEQ	CODTC	RDOMAIN IDVAR IDVARVAL COREF COEVAL
		SE	Subject Elements	The subject element table describes the actual order of elements followed by the subject, together with the start date/time and end date/time for each element.	Special Purpose Domains	One record per actual Element per subject	Tabulation	STUDYID, USUBJID, ETCD, SESTDTC	ETCD	STUDYID DOMAIN USUBJID SESEQ	SESTDTC SEENDTC TAETORD EPOCH	ELEMENT SEUPDES
		SV	Subject Visits	The subject visits table describes the actual start and end data/time for each visit of each individual subject.	Special Purpose Domains	One record per actual visit per subject	Tabulation	STUDYID, USUBJID,VISITNUM	VISITNUM	STUDYID DOMAIN USUBJID	VISITDY SVSTDTC SVENDTC SVSTDY SVENDY	VISIT SVUPDES
		CM	Concomitant Medications	Case report form (CRF) data that captures the Concomitant and Prior Medications/Therapies used by the subject. Examples are the Concomitant Medications/Therapies given on an as needed basis and the usual Background Medications/Therapies given for a condition.	Interventions	One record per recorded medication occurrence or constant-dosing interval per subject.	Tabulation	STUDYID, USUBJID, CMTRT, CMSTDTC	CMTRT	STUDYID DOMAIN USUBJID CMSEQ CMGRPID CMSPID	CMSTDTC CMENDTC CMSTDY CMENDY CMDUR CMSTRF CMENRF STRTPT STTPT ENRTPT ENTPT	MODIFY DECOD CAT SCAT PRESP OCCUR STAT REASND INDC CLAS CLASD DOSE DOSTXT DOSU DOSFRM DOSFRQ DOSTOT DOSRGM ROUTE
		EX	Exposure	The Exposure domain model records the details of a subject's exposure to protocol-specified study treatment. Study treatment may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject.	Interventions	One record per constant dosing interval per subject	Tabulation	STUDYID, USUBJID, EXTRT, EXSTDTC	EXTRT	STUDYID DOMAIN USUBJID --SEQ --GRPID --REFID --SPID --LNKID --LNKGRP	EPOCH --STDTC --ENDTC --STDY --ENDY --DUR --TPT --TPTNUM --ELTM --TPTREF --RFTDTC	--CAT --SCAT --DOSE --DOSTXT --DOSU --DOSFRM --DOSFRQ --DOSRGM --ROUTE --LOT --LOC --LAT --DIR --FAST --ADJ*
		EC	Exposure as Collected	The Exposure as Collected domain model reflects protocol-specified study treatment administrations, as collected.					ECTRT	STUDYID DOMAIN USUBJID --SEQ --GRPID --REFID --SPID --LNKID --LNKGRP	EPOCH --STDTC --ENDTC --STDY --ENDY --DUR --TPT --TPTNUM --ELTM --TPTREF --RFTDTC	--MOOD --CAT --SCAT --PRESP --OCCUR --DOSE --DOSTXT --DOSU --DOSFRM --DOSFRQ --DOSTOT --DOSRGM --ROUTE --LOT --LOC --LAT --DIR --PORTOT --FAST --PSTRG --PSTRGU --ADJ*
		PR	Procedures	The Procedures domain model reflects collected details describing a subject’s therapeutic and diagnostic procedures.					PRTRT	STUDYID DOMAIN USUBJID --SEQ --GRPID --REFID --SPID --LNKID --LNKGRP	VISITNUM VISIT VISITDY --STDTC --ENDTC --STDY --ENDY --DUR --TPT --TPTNUM --ELTM --TPTREF --RFTDTC --STRTPT --STTPT --ENRTPT --ENTPT	--DECOD --CAT --SCAT --PRESP --OCCUR --INDC --DOSE --DOSTXT --DOSU --DOSFRM --DOSFRQ --DOSRGM --ROUTE --LOC --LAT --DIR --PORTOT
		SU	Substance Use	The intent of the domain is to capture substance use information that may be used to assess the efficacy and/or safety of therapies that look to mitigate the effects of chronic substance use.	Interventions	One record per substance type per reported occurrence per subject	Tabulation	STUDYID,USUBJID, SUTRT, SUSTDTC	SUTRT	STUDYID DOMAIN USUBJID --SEQ --GRPID --SPID	--STDTC --ENDTC --STDY --ENDY --DUR --STRF --ENRF --STRTPT --STTPT --ENRTPT --ENTPT	--MODIFY --DECOD --CAT --SCAT --PRESP --OCCUR --STAT --REASND --CLAS --CLASCD --DOSE --DOSTXT --DOSU --DOSFRM --DOSFRQ --DOSTOT --ROUTE
		AE	Adverse Events	Adverse events may be captured either as free text or a pre-specified list of terms.	Events	One record per adverse event per subject	Tabulation	STUDYID, USUBJID, AEDECOD, AESTDTC	AETERM	STUDYID DOMAIN USUBJID --SEQ --GRPID --REFID --SPID	--STDTC --ENDTC --STDY --ENDY --DUR --ENRF --ENRTPT --ENTPT	--MODIFY --LLT --LLTCD --DECOD --PTCD --HLT --HLTCD --HLGT --HLGTCD --CAT --SCAT --PRESP --BODSYS --BDSYCD --SOC --SOCCD --LOC --SEV --SER --ACN --ACNOTH --REL --RELNST --PATT --OUT --SCAN --SCONG --SDISAB --SDTH --SHOSP --SLIFE --SOD --SMIE --CONTRT --TOXGR
		DS	Disposition	A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to disposition. (NCI)	Events	One record per disposition status or protocol milestone per subject	Tabulation	STUDYID, USUBJID, DSDECOD, DSSTDTC	DSTERM	STUDYID DOMAIN USUBJID --SEQ --GRPID --SPID	EPOCH --DTC --STDTC --STDY	--DECOD --CAT --SCAT
		HO	Healthcare Encounters	The Healthcare Encounters dataset includes inpatient and outpatient healthcare events (e.g., hospitalizations, nursing home stay, rehabilitation facility stays, ambulatory surgery).	Events				HOTERM	STUDYID DOMAIN USUBJID --SEQ --GRPID --REFID --SPID	--DTC --STDTC --ENDTC --DY --STDY --ENDY --DUR --STRTPT --STTPT --ENRTPT --ENTPT	--DECOD --CAT --SCAT --PRESP --OCCUR --STAT --REASND
		MH	Medical History	The medical history dataset includes the subject's prior history at the start of the trial. Examples of subject medical history information could include general medical history, gynecological history, and primary diagnosis.	Events	One record per medical history event per subject	Tabulation	STUDYID, USUBJID, MHDECOD	MHTERM	STUDYID DOMAIN USUBJID --SEQ --GRPID --REFID --SPID	--DTC --STDTC --ENDTC --DY --ENRF --ENRTPT --ENTPT	--MODIFY --DECOD --CAT --SCAT --PRESP --OCCUR --STAT --REASND --BODSYS
		DV	Protocol Deviations	The intent of the domain is to capture protocol violations and deviations during the course of the study and will store only those criteria violation by or deviated from by the subject and not a response to each violation or deviation.	Events	One record per protocol deviation per subject	Tabulation	STUDYID, USUBJID, DVTERM, DVSTDTC, CETERM	DVTERM	STUDYID DOMAIN USUBJID --SEQ --REFID --SPID	EPOCH --STDTC --ENDTC	--DECOD --CAT --SCAT
		CE	Clinical Events	A dataset used to capture clinical events of interest that would not be classified as adverse events.	Events	One record per event per subject	Tabulation	STUDYID, USUBJID, CESTDTC	CETERM	STUDYID DOMAIN USUBJID --SEQ --GRPID --REFID --SPID	--DTC --STDTC --ENDTC --DY --STRF --ENRF --STRTPT --STTPT --ENRTPT --ENTPT	--DECOD --CAT --SCAT --PRESP --OCCUR --STAT --REASND --BODSYS --SEV
		EG	ECG Test Results	Findings related to the collection of ECG data, including position of the subject, method of evaluation, all cycle measurements and all findings from the ECG including an overall interpretation if collected or derived.	Findings	One record per ECG observation per time point per visit per subject	Tabulation	STUDYID, USUBJID, EGTESTCD, VISITNUM, EGTPTREF, EGTPTNUM	EGTESTCD	STUDYID DOMAIN USUBJID --SEQ --GRPID --REFID --SPID	VISITNUM VISIT VISITDY --DTC --DY --TPT --TPTNUM --ELTM --TPTREF --RFTDTC	--TEST --CAT --SCAT --POS --ORRES --ORRESU --STRESC --STRESN --STRESU --STAT --REASND --FXN --NAM --LEAD --METHOD --BLFL --DRVFL --EVAL
		IE	Inclusion/ Exclusion Criteria Not Met	The intent of the domain model is to only collect those criteria that cause the subject to be in violation of the inclusion/exclusion criteria not a response to each criterion.	Findings	One record per inclusion/exclusion criterion not met per subject	Tabulation	STUDYID, USUBJID, IETESTCD	IETESTCD	STUDYID DOMAIN USUBJID --SEQ --SPID	VISITNUM VISIT VISITDY --DTC --DY	--TEST --CAT --SCAT --ORRES --STRESC
		IS	Immunogenicity Specimen Assessment	It is intended to be used only for data collected regarding the immunogenic potential of materials under study.	Findings				ISTEST	STUDYID DOMAIN USUBJID --SEQ --GRPID --REFID --SPID --TESTCD	VISITNUM VISIT VISITDY --DTC --DY	--CAT --SCAT --ORRES --ORRESU --STRESC --STRESN --STRESU --STAT --REASND --NAM --SPEC --METHOD --BLFL --LLOQ
		LB	Laboratory Test Results	Laboratory test findings including, but is not limited to hematology, clinical chemistry and urinalysis data. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains.	Findings	One record per analyte per planned time point number per time point reference per visit per subject	Tabulation	STUDYID, USUBJID, LBTESTCD, LBSPEC, VISITNUM, LBTPTREF, LBTPTNUM	LBTESTCD	STUDYID DOMAIN USUBJID --SEQ --GRPID --REFID --SPID	VISITNUM VISIT VISITDY --DTC --ENDTC --DY --TPT --TPTNUM --ELTM --TPTREF --RFTDTC	--TEST --CAT --SCAT --ORRES --ORRESU --ORNRLO --ORNRHI --STRESC --STRESN --STRESU --STNRLO --STNRHI --STNRC --NRIND --STAT --REASND --NAM --LOINC --SPEC --SPCCND --METHOD --BLFL --FAST --DRVFL --TOX --TOXGR
		PE	Physical Examination	Findings collected during a physical examination of the subject. It has findings that are discovered that are related to body systems. Does not include vital signs measurements, which are stored in the vital signs domain.	Findings	One record per body system or abnormality per visit per subject	Tabulation	STUDYID, USUBJID, PETESTCD, VISITNUM	PETESTCD	STUDYID DOMAIN USUBJID PESEQ PEGRPID PESPID	VISITNUM VISIT VISITDY PEDTC PEDY	PETEST PEMODIFY PECAT PESCAT PEBODSYS PEORRES PEORRESU PESTRESC PESTAT PEREASND PELOC PEMETHOD PEEVAL
		QS	Questionnaire	Questionnaires are named, stand-alone instruments designed to provide an assessment of a concept. Questionnaires have a defined standard structure, format, and content; consist of conceptually related items that are typically scored; and have documented methods for administration and analysis.	Findings	One record per questionnaire per question per time point per visit per subject	Tabulation	STUDYID, USUBJID, QSCAT, QSTESTCD, VISITNUM, QSTPTREF, QSTPTNUM	QSTESTCD	STUDYID DOMAIN USUBJID QSSEQ QSGRPID QSSPID	VISITNUM VISIT VISITDY QSDTC QSDY QSTPT QSTPTNUM QSELTM QSTPTREF QSRFTDTC QSEVLINT	QSTEST QSCAT QSSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSSTAT QSREASND QSBLFL QSDRVFL QSEVAL
		RP	Reproductive System Findings	The Reproductive System Findings domain captures all Reproductive information related to a subject	Findings				RPTESTCD	STUDYID DOMAIN USUBJID RPSEQ RPGRPID RPREFID RPSPID	VISITNUM VISIT VISITDY RPDTC RPDY	RPTEST RPCAT RPSCAT RPORRES RPORRESU RPSTRESC RPSTRESN RPSTRESU RPSTAT RPREASND RPBLFL RPDRVFL
		SC	Subject Characteristics	The subject characteristics domain is for data not collected in other domains that is subject-related.	Findings	One record per characteristic per subject	Tabulation	STUDYID, USUBJID, SCTESTCD	SCTESTCD	STUDYID DOMAIN USUBJID SCSEQ SCGRPID SCSPID	SCDTC SCDY	SCTEST SCCAT SCSCAT SCORRES SCORRESU SCSTRESC SCSTRESN SCSTRESU SCSTAT SCREASND
		SS	Subject status	Subject Status is for data relating to general subject characteristics that are evaluated periodically to determine if they have changed.	Findings				SSTESTCD	STUDYID DOMAIN USUBJID SSSEQ SSGRPID SSSPID	VISITNUM VISIT VISITDY SSDTC SSDY	SSTEST SSCAT SSSCAT SSORRES SSSTRESC SSSTAT SSREASND SSEVAL
		VS	Vital Signs	Measurements including but not limited to blood pressure, temperature, respiration, body surface area, BMI, height and weight.	Findings	One record per vital sign measurement per time point per visit per subject	Tabulation	STUDYID, USUBJID, VSTESTCD, VISITNUM, VSTPTREF, VSTPTNUM	VSTESTCD	STUDYID DOMAIN USUBJID VSSEQ VSGRPID VSSPID	VISITNUM VISIT VISITDY VSDTC VSDY VSTPT VSTPTNUM VSELTM VSTPTREF VSRFTDTC	VSTEST VSCAT VSSCAT VSPOS VSORRES VSORRESU VSSTRESC VSSTRESN VSSTRESU VSSTAT VSREASND VSLOC VSLAT VSBLFL VSDRVFL
		DA	Drug Accountability	Data regarding the accountability of study drug, such as information on the receipt, dispensing, return, and packaging.	Findings	One record per drug accountability finding per subject	Tabulation	STUDYID, USUBJID, DATESTCD, DADTC	DATESTCD	STUDYID DOMAIN USUBJID DASEQ DAGRPID DAREFID DASPID	VISITNUM VISIT VISITDY DADTC DADY	DATEST DACAT DASCAT DAORRES DAORRESU DASTRESC DASTRESN DASTRESU DASTAT DAREASND
		MB	Microbiology Specimen	Microbiology specimen findings, including gram stain results, and organisms found.	Findings	One record per microbiology specimen finding per time point per visit per subject	Tabulation	STUDYID, USUBJID, MBTESTCD, VISITNUM, MBTPTREF, MBTPTNUM	MBTESTCD	STUDYID DOMAIN USUBJID MBSEQ MBGRPID MBREFID MBSPID	VISITNUM VISIT VISITDY MBDTC MBDY MBTPT MBTPTNUM MBELTM MBTPTREF MBRFTDTC	MBTEST MBCAT MBSCAT MBORRES MBORRESU MBSTRESC MBSTRESN MBSTRESU MBRESCAT MBSTAT MBREASND MBNAM MBLOINC MBSPEC MBSPCCND MBLOC MBMETHOD MBBLFL MBDRVFL
		MS	Microbiology Susceptibility	This includes microbiology susceptibility test results, plus results of any other organism-related tests.	Findings	One record per microbiology susceptibility test (or other organism- related finding) per organism found in MB	Tabulation	STUDYID, USUBJID, MSTESTCD, VISITNUM, MSTPTREF, MSTPTNUM	MSTESTCD	STUDYID DOMAIN USUBJID MSSEQ MSGRPID MSREFID MSSPID	VISITNUM VISIT VISITDY MSDTC MSDY MSTPT MSTPTNUM MSELTM MSTPTREF	MSTEST MSCAT MSSCAT MSORRES MSORRESU MSSTRESC MSSTRESN MSSTRESU MSRESCAT MSSTAT MSREASND MSNAM MSLOINC MSMETHOD MSBLFL MSDRVFL
		PC	Pharmacokinetic Concentrations	Concentrations of drugs/metabolites in fluids or tissues as a function of time.	Findings	One record per analyte per planned time point number per time point reference per visit per subject"	Tabulation	STUDYID, USUBJID, PCTESTCD, VISITNUM, PCTPTREF, PCTPTNUM	PCTESTCD	STUDYID DOMAIN USUBJID PCSEQ PCGRPID PCREFID PCSPID	VISITNUM VISIT VISITDY PCDTC PCENDTC PCDY PCTPT PCTPTNUM PCELTM PCTPTREF PCRFTDTC PCEVLINT	PCTEST PCCAT PCSCAT PCORRES PCORRESU PCSTRESC PCSTRESN PCSTRESU PCSTAT PCREASND PCNAM PCSPEC PCSPCCND PCMETHOD PCFAST PCDRVFL PCLLOQ PCULOQ
		PP	Pharmacokinetic Parameters	Pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data.	Findings	One record per PK parameter per time- concentration profile per modeling method per subject	Tabulation	STUDYID, USUBJID, PPTESTCD, PPCAT, VISITNUM, PPTPTREF	PPTESTCD	STUDYID DOMAIN USUBJID PPSEQ PPGRPID	PPDTC PPRFTDTC PPSTINT PPENINT	PPTEST PPCAT PPSCAT PPORRES PPORRESU PPSTRESC PPSTRESN PPSTRESU PPSTAT PPREASND PPSPEC
		FA	Findings About Events or Interventions	A dataset used to capture the findings about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier.	Findings	One record per finding per object per time point per time point reference per visit per subject	Tabulation	STUDYID, USUBJID, FATESTCD, FAOBJ, VISITNUM, FATPTREF, FATPTNUM	FATESTCD	STUDYID DOMAIN USUBJID FASEQ FAGRPID FASPID	VISITNUM VISIT VISITDY FADTC FADY	FATEST FAOBJ FACAT FASCAT FAORRES FAORRESU FASTRESC FASTRESN FASTRESU FASTAT FAREASND FALOC FALAT FABLFL FAEVAL
		TA	Trial Arms	The trial arms table describes each planned arm in the trial. An arm is described as an ordered sequence of elements.	Trial Design	One record per planned Element per Arm	Tabulation	STUDYID, ARMCD, TAETORD	ARMCD	STUDYID DOMAIN	TAETORD EPOCH	ARM ETCD ELEMENT	TABRANCH TATRANS
		TV	Trial Visits	The Trial Visits (TV) dataset describes the planned Visits in a trial. Visits are defined as "clinical encounters" and are described using the timing variables VISIT, VISITNUM, and VISITDY. Protocols define Visits in order to describe assessments and procedures that are to be performed at the Visits.	Trial Design	One record per planned Visit per Arm	Tabulation	STUDYID, VISITNUM, ARMCD	VISITNUM	STUDYID DOMAIN	VISITDY	VISIT ARMCD ARM	TVSTRL TVENRL
		TI	Trial Inclusion/ Exclusion Criteria	The Trial Inclusion Exclusion (TI) dataset is not subject oriented. It contains all the inclusion and exclusion criteria for the trial, and thus provides information that may not be present in the subject-level data on inclusion and exclusion criteria. The IE domain contains records only for inclusion and exclusion criteria that subjects did not meet.	Trial Design	One record per I/E criterion	Tabulation	STUDYID, IETESTCD	IETESTCD	STUDYID DOMAIN		IETEST IECAT IESCAT TIVERS	TIRL
		TS	Trial Summary	The Trial Summary (TS) dataset allows the sponsor to submit a summary of the trial in a structured format. Each record in the Trial Summary dataset contains the value of a parameter, a characteristic of the trial. For example, Trial Summary is used to record basic information about the study such as trial phase, protocol title, and trial objectives. The Trial Summary dataset contains information about the planned and actual trial characteristics.	Trial Design	One record per trial summary parameter value	Tabulation	STUDYID, TSPARMCD, TSSEQ	TSPARMCD	STUDYID DOMAIN TSSEQ TSGRPID		TSPARM TSVAL TSVALNF TSVALCD TSVCDREF TSVCDVER
		TE	Trial Elements	describes the Elements used in the trial. The Trial Elements (TE) dataset contains the definitions of the elements that appear in the Trial Arms (TA) dataset. An Element may appear multiple times in the Trial Arms table because it appears either 1) in multiple Arms, 2) multiple times within an Arm, or 3) both. However, an Element will appear only once in the Trial Elements table.	Trial Design	One record per planned Element	Tabulation	STUDYID, ETCD	ETCD	STUDYID DOMAIN	TEDUR	ELEMENT	TESTRL TEENRL
		RELREC	Related Records	The Related Records (RELREC) special-purpose dataset can also be used to identify relationships between datasets (e.g., a one-to-many or parent-child relationship). The relationship is defined by including a single record for each related dataset that identifies the key(s) of the dataset that can be used to relate the respective records.  Relationships between datasets should only be recorded in the RELREC dataset when the sponsor has found it necessary to split information between datasets that are related, and that may need to be examined together for analysis or proper interpretation. Note that it is not necessary to use the RELREC dataset to identify associations from data in the SUPP-- datasets or the CO dataset to their parent general-observation-class dataset records or  special-purpose domain records, as both these datasets include the key variable identifiers of the parent record(s) that are necessary to make the association.	Special Purpose Datasets	One record per related record, group of records or datasets	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID	There have no Role column in IG	STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELID		RELTYPE
		SUPP-- **	Supplemental Qualifiers for [domain name]		Special-Purpose Datasets	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM		STUDYID RDOMAIN USUBJID IDVAR IDVARVAL		QNAM QLABEL QVAL QORIG QEVAL
		DD	Death Details	The domain is designed to hold supplemental data that are typically collected when a death occurs, such as the official cause of death. It does not replace existing data such as the SAE details in AE. Furthermore, it does not introduce a new requirement to collect information that is not already indicated as Good Clinical Practice or defined in regulatory guidelines. Instead, it provides a consistent place within SDTM to hold information that previously did not have a clearly defined home.	Findings				DDTESTCD	STUDYID DOMAIN USUBJID DDSEQ	DDDTC DDDY	DDTEST DDORRES DDSTRESC DDRESCAT DDEVAL
		MI	Microscopic Findings	The Microscopic Findings dataset provides a record for each microscopic finding observed.  There may be multiple microscopic tests on a subject or specimen.	Findings				MITESTCD	STUDYID DOMAIN USUBJID MISEQ MIGRPID MIREFID MISPID	VISITNUM VISIT VISITDY MIDTC MIDY	MITEST MITSTDTL MICAT MISCAT MIORRES MIORRESU MISTRESC MISTRESN MISTRESU MIRESCAT MISTAT MIREASND MINAM MISPEC MISPCCND MILOC MILAT MIDIR MIMETHOD MIBLFL MIEVAL
		MO	Morphology Findings	Macroscopic results (e.g. size, shape, color, and abnormalities of body parts or specimens) that are seen by the naked eye or observed via procedures such as imaging modalities, endoscopy, or other technologies. Many morphology results are obtained from a procedure, although information about the procedure may or may not be collected.	Findings				MOTESTCD	STUDYID DOMAIN USUBJID MOSEQ MOGRPID MOREFID MOSPID MOLNKID	VISITNUM VISIT VISITDY MODTC MODY MOTPT MOTPTNUM MOELTM MOTPTREF MORFTDTC	MOTEST MOCAT MOSCAT MOPOS MOORRES MOORRESU MOSTRESC MOSTRESN MOSTRESU MOSTAT MOREASND MOXFN MONAM MOLOC MOLAT MODIR MOPORTOT MOMETHOD MOANMETH MOBLFL MODRVFL MOEVAL
		TU	Tumor Identification	The TU domain represents data that uniquely identifies tumors (i.e. malignant tumors and other sites of disease, e.g. lymph nodes). The tumors are identified by an investigator and/or independent assessor and classified according to the disease assessment criteria. In RECIST terms this equates to the identification of Target, Non-Target or New tumors. A record in the TU domain contains the following information: a unique tumor ID value; anatomical location of the tumor; method used to identify the tumor; role of the individual identifying the tumor; and timing information.	Findings				TUTESTCD	STUDYID DOMAIN USUBJID TUSEQ TUGRPID TUREFID TUSPID TULNKID	VISITNUM VISIT VISITDY EPOCH TUDTC TUDY	TUTEST TUORRES TUSTRESC TUNAM TULOC TULAT TUDIR TUPORTOT TUMETHOD TUEVAL TUEVALID TUACPTFL
		TR	Tumor Results	The TR domain represents quantitative measurements and/or qualitative assessments of the tumors i.e. malignant tumors and other sites of disease, e.g. lymph nodes) identified in the TU domain. These measurements are usually taken at baseline and then at each subsequent assessment to support response evaluations. A record in the TR domain contains the following information: a unique tumor ID value; test and result; method used; role of the individual assessing the tumor; and timing information.    Clinically accepted evaluation criteria expect that a tumor identified by the tumor ID is the same tumor at each subsequent assessment. The TR domain does not include anatomical location information on each measurement record because this would be a duplication of information already represented in TU. This duplication of data was a deciding factor in multi-domain approach to representing this data.	Findings				TRTESTCD	STUDYID DOMAIN USUBJID TRSEQ TRGRPID TRREFID TRSPID TRLNKID TRLNKGRP	VISITNUM VISIT VISITDY EPOCH TRDTC TRDY	TRTEST TRORRES TRORRESU TRSTRESC TRSTRESN TRSTRESU TRSTAT TRREASND TRNAM TRMETHOD TREVAL TREVALID TRACPTFL
		RS	Disease Response	RS (Disease Response): The RS domain represents the response evaluation(s) determined from the data in TR. Data from other sources (in other SDTM domains) might also be used in an assessment of response.	Findings				RSTESTCD	STUDYID DOMAIN USUBJID RSSEQ RSGRPID RSREFID RSSPID RSLNKID RSLNKGRP	VISITNUM VISIT VISITDY EPOCH RSDTC RSDY	RSTEST RSCAT RSORRES RSSTRESC RSSTAT RSREASND RSNAM RSEVAL RSEVALID RSACPTFL
		SR	Skin Response	The Skin Response (SR) is the first implementation of the Findings About concept that is Findings About an Intervention and uses a different domain code instead of FA.	Findings about or Interventions				SRTESTCD	STUDYID DOMAIN USUBJID SRSEQ SRGRPID SRREFID SRSPID	VISITNUM VISIT VISITDY SRDTC SRDY SRTPT SRTPTNUM SRELTM SRTPTREF SRRFTDTC	SRTEST SROBJ SRCAT SRSCAT SRORRES SRORRESU SRSTRESC SRSTRESN SRSTRESU SRSTAT SRREASND SRNAM SRSPEC SRLOC SRLAT SRMETHOD SREVAL
	C117755	AG	Procedure Agents	A domain for the agents administered to the subject as part of a procedure or assessment as opposed to drugs, medications and therapies administered with therapeutic intent.
	C49565	AU	Autopsy	Additional data about deaths, specific to findings from autopsies.
	C111138	BE	Biospecimen Events	An events domain that documents biospecimen collection and storage information.
	C49566	BM	Bone Measurements	Findings resulting from evaluations of bone mineral density.
	C49567	BR	Biopsy	Findings resulting from biopsies.
	C111137	BS	Biospecimen	A findings domain that documents biospecimen handling information.
	C102605	CV	Cardiovascular System Findings	A domain for physiological findings related to the cardiovascular system, including the heart, blood vessels and lymphatic vessels.
	C102616	DE	Device Events	A domain for device-related events.
	C102618	DI	Device Identifiers	A domain for the submission of information that identifies a specific device unit.
	C102619	DO	Device Properties	A domain for the characteristics of the device that do not vary over the course of the study.
	C95088	DP	Developmental Milestone	This domain captures the outcome of developmental milestone testing during a scheduled period of observation.
	C102620	DR	Device to Subject Relationship	A domain for the linkage of each subject to the device(s) to which they may have been exposed.
	C102621	DT	Device Tracking and Disposition	A domain for logistics and disposition information specific to a given device.
	C102622	DU	Device-In-Use	A domain for the findings for the values of measurements and settings that are intentionally set on a device when it is in use. These are characteristics that exist for the device, and have a specific setting for a use instance.
	C102617	DX	Device Exposure	A domain for a subject's exposure to a medical device under study.
	C102630	ED	Endocrine System Findings	A domain for physiological findings related to the endocrine system, including the glands and cells that make hormones that are released directly into the blood and travel to tissues and organs all over the body.
	C49588	FH	Family History	A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to family history. (NCI)
	C117756	FT	Functional Tests	A domain for named, stand-alone task-based evaluations designed to provide an assessment of mobility, dexterity, or cognitive ability.
	C102640	GI	Gastrointestinal System Findings	A domain for physiological findings related to the gastrointestinal system, including the esophagus, stomach, small and large intestine, anus, liver, biliary tract and pancreas.
	C102641	HM	Hematopoietic System Findings	A domain for physiological findings related to the hematopoietic system, including the bone marrow and lymph nodes involved in the production of blood.
	C49589	HU	Healthcare Resource Utilization	Healthcare resource utilization data such as subject visits to physicians, hospitalizations, and nursing home stays.
	C102651	IG	Integumentary System Findings	A domain for physiological findings related to the integumentary system, including the epidermis, dermis, all of the derivatives of the epidermis, hairs, nails, sudoriferous and sebaceous glands, and mammary glands.
	C102649	IM	Immune System Findings	A domain for physiological findings related to the immune system, including the thymus, spleen and tonsils.
	C102674	MK	Musculoskeletal Findings, Connective and Soft Tissue Findings	A domain for morphological and physiological findings related to the system of muscles, tendons, ligaments, bones, joints and associated tissues.
	C49604	ML	Meal Data	Information regarding the subject's meal consumption, such as fluid intake, amounts, form (solid or liquid state), frequency, etc., typically used for pharmacokinetic analysis.
	C102677	NV	Nervous System Findings	A domain for physiological findings related to the nervous system, including the brain, spinal cord, the cranial and spinal nerves, autonomic ganglia and plexuses.
	C106552	PB	Pharmacogenomics Biomarker	A special-purpose domain that relates a set of genetic variations to an inference about the medical meaning of that set of genetic variations.
	C111289	PF	Pharmacogenomics Findings	A findings domain for gene expression and genetic variation assessments.
	C61529	PG	Pharmacogenomics/Genetics Methods and Supporting Information	Pharmacogenomics findings that initially focus on genotype and gene expression data.
	C111300	PS	Protocol Summary for PGx	A special purpose domain that contains the protocol summary information for pharmacogenomics assessments.
	C111290	PT	Pharmacogenomics Trial Characteristics	A special purpose domain that contains design parameters used in performing pharmacogenomic assessments.
	C95098	RE	Respiratory System Findings	A domain for physiological findings related to the respiratory system, including the organs that are involved in breathing such as the nose, throat, larynx, trachea, bronchi and lungs.
	C106571	SB	Subject Biomarker	A special purpose domain that associates the subject with the medical conclusions contained in the pharmacogenomics biological state (PB) domain based on the observations reported in pharmacogenomics findings (PF) domain.
	C49610	SC	Subject Characteristics	The subject characteristics domain is for data not collected in other domains that is subject-related.
	C49611	SG	Surgery	Surgical information.
	C49612	SK	Skin Test	Findings from diagnostic skin tests.
	C49613	SL	Sleep Polysomnography Data	Findings from diagnostic sleep tests (polysomnography).
	C95100	TF	Tumor Findings	This domain captures the tumor findings of the nonclinical subject.
	C95101	TP	Trial Paths	The trial paths domain is not subject oriented. This domain provides the complete planned non-treatment related sequences of stages for each path in a study.
	C95103	TX	Trial Sets	The trial stages domain is not subject oriented. It contains one record for each trial set characteristic including experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations.
	C102726	UR	Urinary System Findings	A domain for physiological findings related to the urinary tract, including the organs involved in the creation and excretion of urine such as the kidneys, ureters, bladder and urethra.
	C106581	VR	Viral Resistance Findings	A findings domain that contains information about virus drug-resistance.