define.xml - SDTM - HF-1002-CL-101

Datasets

Dataset	Label	Class	Vars	Keys
`TS`	Trial Summary	Trial Design	7	STUDYID, TSPARMCD, TSSEQ
`TA`	Trial Arms	Trial Design	10	STUDYID, ARMCD, TAETORD
`TE`	Trial Elements	Trial Design	6	STUDYID, ETCD
`TV`	Trial Visits	Trial Design	9	STUDYID, VISITNUM, ARMCD
`TI`	Trial Inclusion/Exclusion Criteria	Trial Design	5	STUDYID, IETESTCD
`DM`	Demographics	Special Purpose	24	STUDYID, USUBJID
`SE`	Subject Elements	Special Purpose	10	STUDYID, USUBJID, ETCD, SESTDTC
`SV`	Subject Visits	Special Purpose	10	STUDYID, USUBJID, VISITNUM
`EX`	Exposure	Interventions	16	STUDYID, USUBJID, EXTRT, EXSTDTC
`SUPPEX`	Supplemental Qualifiers for EX	Relationship	10	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM
`CM`	Concomitant Medications	Interventions	18	STUDYID, USUBJID, CMTRT, CMSTDTC
`AE`	Adverse Events	Events	22	STUDYID, USUBJID, AEDECOD, AESTDTC
`SUPPAE`	Supplemental Qualifiers for AE	Relationship	10	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM
`MH`	Medical History	Events	11	STUDYID, USUBJID, MHDECOD, MHSTDTC
`DS`	Disposition	Events	13	STUDYID, USUBJID, DSDECOD, DSSTDTC
`SUPPDS`	Supplemental Qualifiers for DS	Relationship	10	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM
`CE`	Clinical Events	Events	12	STUDYID, USUBJID, CEDECOD, CESTDTC
`VS`	Vital Signs	Findings	18	STUDYID, USUBJID, VSTESTCD, VISITNUM
`LB`	Laboratory Test Results	Findings	24	STUDYID, USUBJID, LBTESTCD, VISITNUM
`EG`	ECG Test Results	Findings	17	STUDYID, USUBJID, EGTESTCD, VISITNUM
`IS`	Immunogenicity Specimen Assessments	Findings	18	STUDYID, USUBJID, ISTESTCD, VISITNUM
`QS`	Questionnaires	Findings	16	STUDYID, USUBJID, QSTESTCD, VISITNUM
`FT`	Functional Tests	Findings	18	STUDYID, USUBJID, FTTESTCD, VISITNUM
`ZE`	Echocardiography (Custom)	Findings	19	STUDYID, USUBJID, ZETESTCD, ZEEVAL, VISITNUM
`PE`	Physical Examination (Custom)	Findings	13	STUDYID, USUBJID, PETESTCD, VISITNUM
`SUPPPE`	Supplemental Qualifiers for PE	Relationship	10	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM
`RELREC`	Related Records	Relationship	7	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL

Variable definitions

TS Trial Summary

One record per trial summary parameter value

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	TSSEQ	Sequence Number	Num	8	Derived	3
4	TSPARMCD	Trial Summary Parameter Short Name	Char	7	Collected	2
5	TSPARM	Trial Summary Parameter	Char	36	Collected
6	TSVAL	Parameter Value	Char	200	Collected
7	TSVAL1	TSVAL1	Char	39	Collected

TA Trial Arms

One record per planned element per arm

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	ARMCD	Planned Arm Code	Char	2	Assigned	2
4	ARM	Description of Planned Arm	Char	15	Assigned
5	TAETORD	Planned Order of Element within Arm	Num	8	Collected	3
6	ETCD	Element Code	Char	4	Assigned
7	ELEMENT	Description of Element	Char	19	Assigned
8	TABRANCH	Branch	Char	1	Collected
9	TATRANS	Transition Rule	Char	1	Collected
10	EPOCH	Epoch	Char	19	Assigned

TE Trial Elements

One record per planned element

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	ETCD	Element Code	Char	4	Assigned	2
4	ELEMENT	Description of Element	Char	19	Assigned
5	TESTRL	Rule for Start of Element	Char	16	Collected
6	TEENRL	Rule for End of Element	Char	37	Collected

TV Trial Visits

One record per planned visit per arm

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	VISITNUM	Visit Number	Num	8	Assigned	2
4	VISIT	Visit Name	Char	16	Assigned
5	VISITDY	Planned Study Day of Visit	Num	8	Assigned
6	ARMCD	Planned Arm Code	Char	1	Assigned	3
7	ARM	Description of Planned Arm	Char	1	Assigned
8	TVSTRL	Visit Start Rule	Char	33	Collected
9	TVENRL	Visit End Rule	Char	1	Collected

TI Trial Inclusion/Exclusion Criteria

One record per inclusion/exclusion criterion

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	IETESTCD	IETESTCD	Char	6	Collected	2
4	IETEST	Inclusion/Exclusion Criterion	Char	122	Collected
5	IECAT	Inclusion/Exclusion Category	Char	9	Collected

DM Demographics

One record per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	SUBJID	Subject Identifier for the Study	Char	4	Collected
5	RFSTDTC	Subject Reference Start Date/Time	Char	10	Collected
6	RFENDTC	Subject Reference End Date/Time	Char	10	Collected
7	RFXSTDTC	Date/Time of First Study Treatment	Char	10	Collected
8	RFXENDTC	Date/Time of Last Study Treatment	Char	10	Collected
9	RFICDTC	Date/Time of Informed Consent	Char	10	Collected
10	RFPENDTC	Date/Time of End of Participation	Char	10	Collected
11	DTHDTC	Date/Time of Death	Char	10	Collected
12	DTHFL	Subject Death Flag	Char	1	Collected
13	SITEID	Study Site Identifier	Char	3	Collected
14	BRTHDTC	Date/Time of Birth	Char	10	Collected
15	AGE	Age	Num	8	Collected
16	AGEU	Age Units	Char	5	Collected
17	SEX	Sex	Char	1	Collected
18	RACE	Race	Char	25	Collected
19	ETHNIC	Ethnicity	Char	22	Collected
20	ARMCD	Planned Arm Code	Char	2	Assigned
21	ARM	Description of Planned Arm	Char	15	Assigned
22	ACTARMCD	Actual Arm Code	Char	2	Assigned
23	ACTARM	Description of Actual Arm	Char	15	Assigned
24	COUNTRY	Country	Char	3	Assigned

SE Subject Elements

One record per actual element per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	SESEQ	Sequence Number	Num	8	Derived
5	ETCD	Element Code	Char	4	Assigned	3
6	ELEMENT	Description of Element	Char	19	Assigned
7	EPOCH	Epoch	Char	19	Assigned
8	TAETORD	Planned Order of Element within Arm	Num	8	Collected
9	SESTDTC	Start Date/Time	Char	10	Collected	4
10	SEENDTC	End Date/Time	Char	10	Collected

SV Subject Visits

One record per actual visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	VISITNUM	Visit Number	Num	8	Assigned	3
5	VISIT	Visit Name	Char	16	Assigned
6	VISITDY	Planned Study Day of Visit	Num	8	Assigned
7	EPOCH	Epoch	Char	19	Assigned
8	SVSTDTC	Start Date/Time	Char	10	Collected
9	SVENDTC	End Date/Time	Char	10	Collected
10	SVSTDY	Study Day of Start	Num	8	Derived

EX Exposure

One record per protocol-specified study treatment per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	EXSEQ	Sequence Number	Num	8	Derived
5	EXTRT	Name of Treatment	Char	7	Collected	3
6	EXDOSE	Dose	Num	8	Collected
7	EXDOSU	Dose Units	Char	2	Collected
8	EXDOSFRM	Dose Form	Char	23	Collected
9	EXROUTE	Route of Administration	Char	13	Collected
10	VISITNUM	Visit Number	Num	8	Assigned
11	VISIT	Visit Name	Char	16	Assigned
12	EPOCH	Epoch	Char	9	Assigned
13	EXSTDTC	Start Date/Time	Char	16	Collected	4
14	EXENDTC	End Date/Time	Char	16	Collected
15	EXSTDY	Study Day of Start	Num	8	Derived
16	EXENDY	Study Day of End	Num	8	Derived

SUPPEX Supplemental Qualifiers for EX

One record per IDVAR, IDVARVAL, and QNAM value per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	RDOMAIN	Related Domain Abbreviation	Char	2	Assigned	2
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	3
4	IDVAR	Identifying Variable	Char	5	Collected	4
5	IDVARVAL	Identifying Variable Value	Char	1	Collected	5
6	QNAM	Qualifier Variable Name	Char	8	Collected	6
7	QLABEL	Qualifier Variable Label	Char	33	Collected
8	QVAL	Data Value	Char	11	Collected
9	QORIG	Origin	Char	9	Collected
10	QEVAL	Evaluator	Char	1	Collected

CM Concomitant Medications

One record per recorded medication per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	CMSEQ	Sequence Number	Num	8	Derived
5	CMTRT	Reported Name of Drug, Med, or Therapy	Char	20	Collected	3
6	CMDECOD	Standardized Medication	Char	24	Assigned
7	CMCLAS	Medication Class	Char	50	Assigned
8	CMINDC	Indication	Char	19	Collected
9	CMDOSE	Dose	Num	8	Collected
10	CMDOSU	Dose Units	Char	2	Collected
11	CMDOSFRQ	Dosing Frequency per Interval	Char	3	Collected
12	CMROUTE	Route of Administration	Char	4	Collected
13	CMSTDTC	Start Date/Time	Char	10	Collected	4
14	CMENDTC	End Date/Time	Char	1	Collected
15	CMSTDY	Study Day of Start	Num	8	Derived
16	CMENDY	Study Day of End	Num	8	Derived
17	CMENRTPT	End Relative to Reference Time Point	Char	7	Collected
18	CMENTPT	End Reference Time Point	Char	12	Collected

AE Adverse Events

One record per adverse event per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	AESEQ	Sequence Number	Num	8	Derived
5	AETERM	Reported Term for the Adverse Event	Char	45	Collected
6	AEDECOD	Standardized Adverse Event	Char	25	Assigned	3
7	AEBODSYS	Body System or Organ Class	Char	52	Assigned
8	AESER	Serious Event	Char	1	Collected
9	AESDTH	Results in Death	Char	1	Collected
10	AESHOSP	Requires or Prolongs Hospitalization	Char	1	Collected
11	AEACN	Action Taken with Study Treatment	Char	14	Collected
12	AEREL	Causality	Char	16	Collected
13	AEOUT	Outcome of Adverse Event	Char	32	Collected
14	AETOXGR	Standard Toxicity Grade	Char	1	Collected
15	AECONTRT	Concomitant or Additional Trtmnt Given	Char	1	Collected
16	EPOCH	Epoch	Char	9	Assigned
17	AESTDTC	Start Date/Time	Char	10	Collected	4
18	AEENDTC	End Date/Time	Char	10	Collected
19	AESTDY	Study Day of Start	Num	8	Derived
20	AEENDY	Study Day of End	Num	8	Derived
21	AEENRTPT	End Relative to Reference Time Point	Char	1	Collected
22	AEENTPT	End Reference Time Point	Char	1	Collected

SUPPAE Supplemental Qualifiers for AE

One record per IDVAR, IDVARVAL, and QNAM value per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	RDOMAIN	Related Domain Abbreviation	Char	2	Assigned	2
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	3
4	IDVAR	Identifying Variable	Char	5	Collected	4
5	IDVARVAL	Identifying Variable Value	Char	1	Collected	5
6	QNAM	Qualifier Variable Name	Char	5	Collected	6
7	QLABEL	Qualifier Variable Label	Char	22	Collected
8	QVAL	Data Value	Char	1	Collected
9	QORIG	Origin	Char	9	Collected
10	QEVAL	Evaluator	Char	12	Collected

MH Medical History

One record per medical history event per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	MHSEQ	Sequence Number	Num	8	Derived
5	MHTERM	Reported Term for the Medical History	Char	34	Collected
6	MHDECOD	Standardized Medical History	Char	24	Assigned	3
7	MHBODSYS	Body System or Organ Class	Char	34	Assigned
8	MHCAT	Category	Char	7	Collected
9	MHSTDTC	Start Date/Time	Char	4	Collected	4
10	MHENRTPT	End Relative to Reference Time Point	Char	7	Collected
11	MHENTPT	End Reference Time Point	Char	12	Collected

DS Disposition

One record per disposition status or milestone per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	DSSEQ	Sequence Number	Num	8	Derived
5	DSTERM	Reported Term for the Disposition Event	Char	36	Collected
6	DSDECOD	Standardized Disposition Term	Char	25	Assigned	3
7	DSCAT	Category	Char	18	Collected
8	DSSCAT	Subcategory	Char	15	Collected
9	VISITNUM	Visit Number	Num	8	Assigned
10	VISIT	Visit Name	Char	15	Assigned
11	EPOCH	Epoch	Char	19	Assigned
12	DSSTDTC	Start Date/Time	Char	10	Collected	4
13	DSSTDY	Study Day of Start	Num	8	Derived

SUPPDS Supplemental Qualifiers for DS

One record per IDVAR, IDVARVAL, and QNAM value per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	RDOMAIN	Related Domain Abbreviation	Char	2	Assigned	2
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	3
4	IDVAR	Identifying Variable	Char	5	Collected	4
5	IDVARVAL	Identifying Variable Value	Char	1	Collected	5
6	QNAM	Qualifier Variable Name	Char	8	Collected	6
7	QLABEL	Qualifier Variable Label	Char	13	Collected
8	QVAL	Data Value	Char	37	Collected
9	QORIG	Origin	Char	9	Collected
10	QEVAL	Evaluator	Char	1	Collected

CE Clinical Events

One record per clinical event per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	CESEQ	Sequence Number	Num	8	Derived
5	CETERM	Reported Term for the Clinical Event	Char	18	Collected
6	CEDECOD	Standardized Clinical Event	Char	15	Assigned	3
7	CECAT	Category	Char	25	Collected
8	VISITNUM	Visit Number	Num	8	Assigned
9	VISIT	Visit Name	Char	15	Assigned
10	EPOCH	Epoch	Char	19	Assigned
11	CESTDTC	Start Date/Time	Char	10	Collected	4
12	CESTDY	Study Day of Start	Num	8	Derived

VS Vital Signs

One record per vital sign measurement per visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	VSSEQ	Sequence Number	Num	8	Derived
5	VSTESTCD	Vital Signs Test Short Name	Char	6	Collected	3
6	VSTEST	Vital Signs Test Name	Char	24	Collected
7	VSPOS	Vital Signs Position of Subject	Char	6	Collected
8	VSORRES	Result or Finding in Original Units	Char	5	Collected
9	VSORRESU	Original Units	Char	11	Collected
10	VSSTRESC	Character Result/Finding in Std Format	Char	5	Derived
11	VSSTRESN	Numeric Result/Finding in Standard Units	Num	8	Derived
12	VSSTRESU	Standard Units	Char	11	Derived
13	VSBLFL	Baseline Flag	Char	1	Derived
14	VISITNUM	Visit Number	Num	8	Assigned	4
15	VISIT	Visit Name	Char	16	Assigned
16	EPOCH	Epoch	Char	9	Assigned
17	VSDTC	Date/Time of Collection	Char	16	Collected
18	VSDY	Study Day of Visit/Collection	Num	8	Derived

LB Laboratory Test Results

One record per lab test per visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	LBSEQ	Sequence Number	Num	8	Derived
5	LBCAT	Category	Char	10	Collected
6	LBTESTCD	Lab Test Short Name	Char	8	Collected	3
7	LBTEST	Lab Test Name	Char	26	Collected
8	LBORRES	Result or Finding in Original Units	Char	5	Collected
9	LBORRESU	Original Units	Char	6	Collected
10	LBORNRLO	Reference Range Lower Limit-Orig Unit	Char	4	Collected
11	LBORNRHI	Reference Range Upper Limit-Orig Unit	Char	4	Collected
12	LBSTRESC	Character Result/Finding in Std Format	Char	5	Derived
13	LBSTRESN	Numeric Result/Finding in Standard Units	Num	8	Derived
14	LBSTRESU	Standard Units	Char	6	Derived
15	LBSTNRLO	Reference Range Lower Limit-Std Units	Num	8	Derived
16	LBSTNRHI	Reference Range Upper Limit-Std Units	Num	8	Derived
17	LBNRIND	Reference Range Indicator	Char	6	Collected
18	LBSPEC	Specimen Type	Char	11	Collected
19	LBBLFL	Baseline Flag	Char	1	Derived
20	VISITNUM	Visit Number	Num	8	Assigned	4
21	VISIT	Visit Name	Char	16	Assigned
22	EPOCH	Epoch	Char	9	Assigned
23	LBDTC	Date/Time of Collection	Char	10	Collected
24	LBDY	Study Day of Visit/Collection	Num	8	Derived

EG ECG Test Results

One record per ECG measurement per visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	EGSEQ	Sequence Number	Num	8	Derived
5	EGTESTCD	ECG Test Short Name	Char	5	Collected	3
6	EGTEST	ECG Test Name	Char	36	Collected
7	EGORRES	Result or Finding in Original Units	Char	36	Collected
8	EGORRESU	Original Units	Char	9	Collected
9	EGSTRESC	Character Result/Finding in Std Format	Char	36	Derived
10	EGSTRESN	Numeric Result/Finding in Standard Units	Num	8	Derived
11	EGSTRESU	Standard Units	Char	9	Derived
12	EGBLFL	Baseline Flag	Char	1	Derived
13	VISITNUM	Visit Number	Num	8	Assigned	4
14	VISIT	Visit Name	Char	16	Assigned
15	EPOCH	Epoch	Char	9	Assigned
16	EGDTC	Date/Time of Collection	Char	10	Collected
17	EGDY	Study Day of Visit/Collection	Num	8	Derived

IS Immunogenicity Specimen Assessments

One record per immunogenicity test per visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	ISSEQ	Sequence Number	Num	8	Derived
5	ISCAT	Category	Char	14	Collected
6	ISTESTCD	Immunogenicity Test Short Name	Char	6	Collected	3
7	ISTEST	Immunogenicity Test Name	Char	36	Collected
8	ISORRES	Result or Finding in Original Units	Char	6	Collected
9	ISORRESU	Original Units	Char	15	Collected
10	ISSTRESC	Character Result/Finding in Std Format	Char	6	Derived
11	ISSTRESN	Numeric Result/Finding in Standard Units	Num	8	Derived
12	ISSTRESU	Standard Units	Char	15	Derived
13	ISSPEC	Specimen Type	Char	5	Collected
14	VISITNUM	Visit Number	Num	8	Assigned	4
15	VISIT	Visit Name	Char	16	Assigned
16	EPOCH	Epoch	Char	9	Assigned
17	ISDTC	Date/Time of Collection	Char	10	Collected
18	ISDY	Study Day of Visit/Collection	Num	8	Derived

QS Questionnaires

One record per questionnaire item per visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	QSSEQ	Sequence Number	Num	8	Derived
5	QSCAT	Category	Char	5	Collected
6	QSTESTCD	Question Test Short Name	Char	8	Collected	3
7	QSTEST	Question Test Name	Char	26	Collected
8	QSORRES	Result or Finding in Original Units	Char	4	Collected
9	QSSTRESC	Character Result/Finding in Std Format	Char	4	Derived
10	QSSTRESN	Numeric Result/Finding in Standard Units	Num	8	Derived
11	QSBLFL	Baseline Flag	Char	1	Derived
12	VISITNUM	Visit Number	Num	8	Assigned	4
13	VISIT	Visit Name	Char	15	Assigned
14	EPOCH	Epoch	Char	9	Assigned
15	QSDTC	Date/Time of Collection	Char	10	Collected
16	QSDY	Study Day of Visit/Collection	Num	8	Derived

FT Functional Tests

One record per functional test per visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	FTSEQ	Sequence Number	Num	8	Derived
5	FTCAT	Category	Char	29	Collected
6	FTTESTCD	Functional Test Test Short Name	Char	7	Collected	3
7	FTTEST	Functional Test Test Name	Char	26	Collected
8	FTORRES	Result or Finding in Original Units	Char	4	Collected
9	FTORRESU	Original Units	Char	9	Collected
10	FTSTRESC	Character Result/Finding in Std Format	Char	4	Derived
11	FTSTRESN	Numeric Result/Finding in Standard Units	Num	8	Derived
12	FTSTRESU	Standard Units	Char	9	Derived
13	FTBLFL	Baseline Flag	Char	1	Derived
14	VISITNUM	Visit Number	Num	8	Assigned	4
15	VISIT	Visit Name	Char	15	Assigned
16	EPOCH	Epoch	Char	9	Assigned
17	FTDTC	Date/Time of Collection	Char	10	Collected
18	FTDY	Study Day of Visit/Collection	Num	8	Derived

ZE Echocardiography (Custom)

One record per echo measurement per reader per visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	ZESEQ	Sequence Number	Num	8	Derived
5	ZECAT	Category	Char	16	Collected
6	ZETESTCD	Echo Test Short Name	Char	5	Collected	3
7	ZETEST	Echo Test Name	Char	37	Collected
8	ZEORRES	Result or Finding in Original Units	Char	4	Collected
9	ZEORRESU	Original Units	Char	2	Collected
10	ZESTRESC	Character Result/Finding in Std Format	Char	4	Derived
11	ZESTRESN	Numeric Result/Finding in Standard Units	Num	8	Derived
12	ZESTRESU	Standard Units	Char	2	Derived
13	ZEEVAL	Evaluator	Char	14	Collected	4
14	ZEBLFL	Baseline Flag	Char	1	Derived
15	VISITNUM	Visit Number	Num	8	Assigned	5
16	VISIT	Visit Name	Char	15	Assigned
17	EPOCH	Epoch	Char	9	Assigned
18	ZEDTC	Date/Time of Collection	Char	10	Collected
19	ZEDY	Study Day of Visit/Collection	Num	8	Derived

PE Physical Examination (Custom)

One record per body-system exam per visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	DOMAIN	Domain Abbreviation	Char	2	Assigned
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	2
4	PESEQ	Sequence Number	Num	8	Derived
5	PETESTCD	Exam Test Short Name	Char	5	Collected	3
6	PETEST	Exam Test Name	Char	29	Collected
7	PEORRES	Result or Finding in Original Units	Char	8	Collected
8	PESTRESC	Character Result/Finding in Std Format	Char	8	Derived
9	VISITNUM	Visit Number	Num	8	Assigned	4
10	VISIT	Visit Name	Char	16	Assigned
11	EPOCH	Epoch	Char	9	Assigned
12	PEDTC	Date/Time of Collection	Char	10	Collected
13	PEDY	Study Day of Visit/Collection	Num	8	Derived

SUPPPE Supplemental Qualifiers for PE

One record per IDVAR, IDVARVAL, and QNAM value per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	RDOMAIN	Related Domain Abbreviation	Char	2	Assigned	2
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	3
4	IDVAR	Identifying Variable	Char	5	Collected	4
5	IDVARVAL	Identifying Variable Value	Char	1	Collected	5
6	QNAM	Qualifier Variable Name	Char	7	Collected	6
7	QLABEL	Qualifier Variable Label	Char	23	Collected
8	QVAL	Data Value	Char	18	Collected
9	QORIG	Origin	Char	9	Collected
10	QEVAL	Evaluator	Char	1	Collected

RELREC Related Records

One record per related record per relationship

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Assigned	1
2	RDOMAIN	Related Domain Abbreviation	Char	2	Assigned	2
3	USUBJID	Unique Subject Identifier	Char	23	Assigned	3
4	IDVAR	Identifying Variable	Char	5	Collected	4
5	IDVARVAL	Identifying Variable Value	Char	1	Collected	5
6	RELTYPE	Relationship Type	Char	4	Collected
7	RELID	Relationship Identifier	Char	8	Collected

Controlled terminology

CT No Yes Response

Coded value	Decode
`N`	No
`Y`	Yes
`U`	Unknown
`NA`	Not Applicable

CT Sex

Coded value	Decode
`M`	Male
`F`	Female
`U`	Unknown

CT Outcome of Event

Coded value	Decode
`RECOVERED/RESOLVED`	Recovered/Resolved
`RECOVERED/RESOLVED WITH SEQUELAE`	Recovered/Resolved With Sequelae
`RECOVERING/RESOLVING`	Recovering/Resolving
`NOT RECOVERED/NOT RESOLVED`	Not Recovered/Not Resolved
`FATAL`	Fatal
`UNKNOWN`	Unknown

CT Action Taken with Study Treatment

Coded value	Decode
`NOT APPLICABLE`	Not Applicable
`DOSE NOT CHANGED`	Dose Not Changed
`DRUG WITHDRAWN`	Drug Withdrawn
`DRUG INTERRUPTED`	Drug Interrupted
`DOSE REDUCED`	Dose Reduced
`DOSE INCREASED`	Dose Increased
`UNKNOWN`	Unknown

CT Route of Administration

Coded value	Decode
`ORAL`	Oral
`INTRACORONARY`	Intracoronary
`INTRAVENOUS`	Intravenous
`SUBCUTANEOUS`	Subcutaneous

CT Position

Coded value	Decode
`SUPINE`	Supine
`STANDING`	Standing
`SITTING`	Sitting

CT Reference Range Indicator

Coded value	Decode
`LOW`	Low
`NORMAL`	Normal
`HIGH`	High
`ABNORMAL`	Abnormal

CT Frequency

Coded value	Decode
`QD`	QD
`BID`	BID
`TID`	TID
`ONCE`	ONCE
`PRN`	PRN

Demonstration. Define-XML 2.1 rendering · synthetic data · not for clinical or submission use