Tabulation Datasets for Study CDISC01 (SDTM-IG 3.1.2)
Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
TA	Trial Arms	TRIAL DESIGN	One record per planned Element per Arm	Tabulation	STUDYID, ARMCD, TAETORD	ta.xml
TE	Trial Elements	TRIAL DESIGN	One record per planned Element	Tabulation	STUDYID, ETCD	te.xml
TI	Trial Inclusion/Exclusion Criteria	TRIAL DESIGN	One record per I/E criterion	Tabulation	STUDYID, IETESTCD	ti.xml
TS	Trial Summary	TRIAL DESIGN	One record per trial summary parameter value	Tabulation	STUDYID, TSPARMCD, TSSEQ	ts.xml
TV	Trial Visits	TRIAL DESIGN	One record per planned Visit per Arm	Tabulation	STUDYID, VISITNUM, ARMCD	tv.xml
DM	Demographics	SPECIAL PURPOSE	One record per subject	Tabulation	STUDYID, USUBJID	dm.xml	See Reviewer's Guide, Section 2.1 Demographics Reviewers Guide
SE	Subject Elements	SPECIAL PURPOSE	One record per actual Element per subject	Tabulation	STUDYID, USUBJID, SESTDTC, SEENDTC, TAETORD, ETCD	se.xml
SV	Subject Visits	SPECIAL PURPOSE	One record per actual visit per subject	Tabulation	STUDYID, USUBJID, SVSTDTC, VISITNUM	sv.xml
CM	Concomitant Medications	INTERVENTIONS	One record per recorded medication occurrence or constant-dosing interval per subject	Tabulation	STUDYID, USUBJID, CMSTDTC, CMENDTC, CMCAT, CMTRT, CMDOSTXT, CMDOSU, CMINDC, CMDOSFRQ	cm.xml
EX	Exposure	INTERVENTIONS	One record per constant dosing interval per subject	Tabulation	STUDYID, USUBJID, EXSTDTC, EXENDTC, EXTRT, EXDOSE	ex.xml
AE	Adverse Events	EVENTS	One record per adverse event per subject	Tabulation	STUDYID, USUBJID, AEDECOD, AESTDTC	ae.xml
DS	Disposition	EVENTS	One record per disposition status or protocol milestone per subject	Tabulation	STUDYID, USUBJID, DSSTDY, DSSTDTC, DSCAT, DSDECOD	ds.xml
MH	Medical History	EVENTS	One record per medical history event per subject	Tabulation	STUDYID, USUBJID, MHCAT, MHTERM, MHDTC, MHSTDTC	mh.xml
DA	Drug Accountability	FINDINGS	One record per drug accountability finding per subject	Tabulation	STUDYID, USUBJID, DATESTCD, DADTC	da.xml
EG	ECG Test Results	FINDINGS	One record per ECG observation per visit per subject	Tabulation	STUDYID, USUBJID, EGTESTCD, EGDTC, VISITNUM	eg.xml
IE	Inclusion/Exclusion Criteria Not Met	FINDINGS	One record per inclusion/exclusion criterion not met per subject	Tabulation	STUDYID, USUBJID, IETESTCD	ie.xml
LB	Laboratory Tests Results	FINDINGS	One record per analyte per visit per subject	Tabulation	STUDYID, USUBJID, LBCAT, LBMETHOD, LBTESTCD, LBDTC, VISITNUM	lb.xml
PE	Physical Examination	FINDINGS	One record per body system or abnormality per visit per subject	Tabulation	STUDYID, USUBJID, PETESTCD, PEDTC, VISITNUM	pe.xml
QSCG	Questionnaire-QSCG (Questionnaires)	FINDINGS	One record per questionnaire per question per visit per subject	Tabulation	STUDYID, USUBJID, QSCAT, QSTESTCD, QSDTC, VISITNUM	qscg.xml	QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section. Reviewers Guide
QSCS	Questionnaire-QSCS (Questionnaires)	FINDINGS	One record per questionnaire per question per visit per subject	Tabulation	STUDYID, USUBJID, QSCAT, QSTESTCD, QSDTC, VISITNUM	qscs.xml	QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section. Reviewers Guide
QSMM	Questionnaire-QSMM (Questionnaires)	FINDINGS	One record per questionnaire per question per visit per subject	Tabulation	STUDYID, USUBJID, QSCAT, QSTESTCD, QSDTC, VISITNUM	qsmm.xml	QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section. Reviewers Guide
SC	Subject Characteristics	FINDINGS	One record per characteristic per subject	Tabulation	STUDYID, USUBJID, SCTESTCD	sc.xml
VS	Vital Signs	FINDINGS	One record per vital sign measurement per visit per subject	Tabulation	STUDYID, USUBJID, VSTESTCD, VSDTC, VISITNUM, VSPOS	vs.xml
RELREC	Related Records	RELATIONSHIP	One record per related record, group of records or dataset	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID	relrec.xml
SUPPAE	Supplemental Qualifiers for AE	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppae.xml
SUPPCM	Supplemental Qualifiers for CM	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppcm.xml
SUPPDM	Supplemental Qualifiers for DM	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppdm.xml
SUPPEG	Supplemental Qualifiers for EG	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppeg.xml
SUPPEX	Supplemental Qualifiers for EX	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppex.xml
SUPPLB	Supplemental Qualifiers for LB	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	supplb.xml
SUPPQSCG	Supplemental Qualifiers for QSCG	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppqscg.xml
SUPPQSCS	Supplemental Qualifiers for QSCS	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppqscs.xml
SUPPQSMM	Supplemental Qualifiers for QSMM	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppqsmm.xml
SUPPVS	Supplemental Qualifiers for VS	RELATIONSHIP	One record per IDVAR, IDVARVAL, and QNAM value per subject	Tabulation	STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM	suppvs.xml

Trial Arms (TA) [Location: ta.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["TA" = "Trial Arms"] <Domain Abbreviation (TA)>	Assigned
ARMCD	Planned Arm Code	2	text	8	["WONDER10" = "Miracle Drug 10 mg", "WONDER20" = "Miracle Drug 20 mg", "PLACEBO" = "Placebo", "SCRNFAIL" = "Screen Failure"] <Planned Arm Code>	Assigned
ARM	Description of Planned Arm		text	20	["Miracle Drug 10 mg", "Miracle Drug 20 mg", "Placebo", "Screen Failure"] <Description of Planned Arm>	Protocol
TAETORD	Order of Element within Arm	3	integer	1		Assigned
ETCD	Element Code		text	8		Assigned
ELEMENT	Description of Element		text	40		Protocol
TABRANCH	Branch		text	35		Protocol
TATRANS	Transition Rule		text	1		Protocol
EPOCH	Epoch		text	30		Protocol

Trial Elements (TE) [Location: te.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["TE" = "Trial Elements"] <Domain Abbreviation (TE)>	Assigned
ETCD	Element Code	2	text	8		Assigned
ELEMENT	Description of Element		text	40		Protocol
TESTRL	Rule for Start of Element		text	24		Protocol
TEDUR	Planned Duration of Element		text	4	ISO8601	Protocol

Trial Inclusion/Exclusion Criteria (TI) [Location: ti.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["TI" = "Trial Inclusion/Exclusion Criteria"] <Domain Abbreviation (TI)>	Assigned
IETESTCD	Incl/Excl Criterion Short Name	2	text	6	IE Test Codes	Assigned
IETEST	Inclusion/Exclusion Criterion		text	92	IE Tests	CRF Pages 4 - 5
IECAT	Inclusion/Exclusion Category		text	9		CRF Pages 4 - 5

Trial Summary (TS) [Location: ts.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["TS" = "Trial Summary"] <Domain Abbreviation (TS)>	Assigned
TSSEQ	Sequence Number	3	integer	1		Derived	Sequential number identifying records within each TSPARM in the domain.
TSPARMCD	Trial Summary Parameter Short Name	2	text	8	Trial Summary Parameter Test Code	Assigned
TSPARM	Trial Summary Parameter		text	36	Trial Summary Parameter Test Name	Assigned
TSVAL	Parameter Value		text	57		Protocol

Trial Visits (TV) [Location: tv.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["TV" = "Trial Visits"] <Domain Abbreviation (TV)>	Assigned
VISITNUM	Visit Number	2	integer	2		Assigned
VISIT	Visit Name		text	12		Protocol
VISITDY	Planned Study Day of Visit		integer	3		Protocol
ARMCD	Planned Arm Code	3	text	1		Assigned
TVSTRL	Visit Start Rule		text	30		Protocol

Demographics (DM) [Location: dm.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["DM" = "Demographics"] <Domain Abbreviation (DM)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
SUBJID	Subject Identifier for the Study		text	6		CRF Page 3
RFSTDTC	Subject Reference Start Date/Time		date		ISO8601	Derived	RFSTDTC = first date/time of study drug, for safety subject. Null for screen failures.
RFENDTC	Subject Reference End Date/Time		date		ISO8601	Derived	RFENDTC = termination date, for safety subjects. Null for screen failures.
SITEID	Study Site Identifier		text	3		CRF Page 3
BRTHDTC	Date/Time of Birth		date		ISO8601	CRF Page 6
AGE	Age		integer	2		Derived	Age at Screening Date (Screening Date - Birth date). For the complete algorithm see the referenced external document. Complex Algorithms (complexalgorithms.pdf)
AGEU	Age Units		text	5		Assigned	Defaulted to YEARS
SEX	Sex		text	1	["F" = "Female", "M" = "Male", "U" = "Unknown"] <Sex>	CRF Page 6
RACE	Race		text	40	Race	CRF Page 6
ETHNIC	Ethnicity		text	22	["HISPANIC OR LATINO", "NOT HISPANIC OR LATINO"] <Ethnic Group>	CRF Page 6
ARMCD	Planned Arm Code		text	8	["WONDER10" = "Miracle Drug 10 mg", "WONDER20" = "Miracle Drug 20 mg", "PLACEBO" = "Placebo", "SCRNFAIL" = "Screen Failure"] <Planned Arm Code>	Assigned	Assigned based on Randomization Number. See Note 2.1 Reviewers Guide
ARM	Description of Planned Arm		text	20	["Miracle Drug 10 mg", "Miracle Drug 20 mg", "Placebo", "Screen Failure"] <Description of Planned Arm>	Assigned	Assigned from TA.ARM based on ARMCD.
COUNTRY	Country		text	3	ISO3166	Assigned
Related dataset: Supplemental Qualifiers for DM (SUPPDM)

Subject Elements (SE) [Location: se.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["SE" = "Subject Element"] <Domain Abbreviation (SE)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
SESEQ	Sequence Number		integer	1		Derived	Sequential number identifying records within each USUBJID in the domain.
ETCD	Element Code	6	text	7		Assigned
ELEMENT	Description of Element		text	40		Protocol
SESTDTC	Start Date/Time of Element	3	date		ISO8601	Derived	If Element = SCREEN, derived from SVSTDTC where VISIT = SCREENING or from DS where DSDECOD = 'INFORMED CONSENT', whichever is earliest. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT. For treatment Elements, derived from first EXSTDTC for the element. For the complete algorithm see the referenced external document. Complex Algorithms (complexalgorithms.pdf)
SEENDTC	End Date/Time of Element	4	date		ISO8601	Derived	If Element = SCREEN, derived from SVENDTC where VISIT = SCREENING. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT or from the latest EXENDTC from EX whichever is later. For treatment Elements, derived from last EXENDTC for the element. For the complete algorithm see the referenced external document. Complex Algorithms (complexalgorithms.pdf)
TAETORD	Planned Order of Elements within Arm	5	integer	1		Protocol

Subject Visits (SV) [Location: sv.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["SV" = "Subject Visits"] <Domain Abbreviation (SV)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
VISITNUM	Visit Number	4	integer	2		Derived	Derived from visit-based subject-level domains
VISIT	Visit Name		text	8		Derived	Derived from visit-based subject-level domains
VISITDY	Planned Study Day of Visit		integer	3		Protocol
SVSTDTC	Start Date/Time of Visit	3	date		ISO8601	Derived	Derived from visit-based subject-level domains
SVENDTC	End Date/Time of Visit		date		ISO8601	Derived	SVENDTC = SVSTDTC
SVSTDY	Study Day of Start of Visit		integer	3		Derived	SVSTDY = SVSTDTC-RFSTDTC+1 if SVSTDTC is on or after RFSTDTC. SVSTDTC - RFSTDTC if SVSTDTC precedes RFSTDTC.

Concomitant Medications (CM) [Location: cm.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["CM" = "Concomitant Meds"] <Domain Abbreviation (CM)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
CMSEQ	Sequence Number		integer	2		Derived	Sequential number identifying records within each USUBJID in the domain.
CMTRT	Reported Name of Drug, Med, or Therapy	6	text	23		CRF Pages 9 22
CMMODIFY	Modified Reported Name		text	23		Assigned
CMDECOD	Standardized Medication Name		text	30	Drug Dictionary	Assigned
CMCAT	Category for Medication	5	text	36	["CONCOMITANT MEDICATIONS", "PSYCHOTROPHIC DRUG TREATMENT HISTORY"] <Category for Medication>	CRF Pages 9 22
CMINDC	Indication	9	text	27		CRF Pages 9 22
CMCLAS	Medication Class		text	45	Drug Dictionary	Assigned	Coded to ATC level 3 Term based on CMINDC
CMCLASCD	Medication Class Code		text	3	Drug Dictionary	Assigned	Coded to ATC level 3 Code based on CMINDC
CMDOSTXT	Dose Description	7	text	4		CRF Pages 9 22
CMDOSU	Dose Units	8	text	6	Unit (CM)	CRF Pages 9 22
CMDOSFRQ	Dosing Frequency per Interval	10	text	5	Frequency	CRF Page 22
CMROUTE	Route of Administration		text	12	Route of Administration	CRF Page 22	Free text from CRF mapped to CDISC CT
CMSTDTC	Start Date/Time of Medication	3	date		ISO8601	CRF Pages 9 22
CMENDTC	End Date/Time of Medication	4	date		ISO8601	CRF Pages 9 22
CMSTDY	Study Day of Start of Medication		integer	6		Derived	CMSTDY = CMSTDTC - RFSTDTC +1 if CMSTDTC is on or after RFSTDTC. CMSTDTC - RFSTDTC if CMSTDTC precedes RFSTDTC
CMENDY	Study Day of End of Medication		integer	4		Derived	CMENDY = CMENDTC - RFSTDTC +1 if CMENDTC is on or after RFSTDTC. CMENDTC - RFSTDTC if CMENDTC precedes RFSTDTC
CMENRF	End Relative to Reference Period		text	6	["AFTER"] <Relation to Reference Period (CMENRF)>	CRF Page 22
Related dataset: Supplemental Qualifiers for CM (SUPPCM)

Exposure (EX) [Location: ex.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["EX" = "Exposure"] <Domain Abbreviation (EX)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
EXSEQ	Sequence Number		integer	1		Derived	Sequential number identifying records within each USUBJID in the domain.
EXTRT	Name of Actual Treatment	5	text	20	["Miracle Drug", "Placebo"] <Treatment>	Derived	Derived from ARM, ARMCD
EXDOSE	Dose per Administration	6	integer	2		Derived	If ARMCD=WONDER10 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 10. If ARMCD=WONDER20 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 20. If ARMCD=PLACEBO then EXDOSE = 0.
EXDOSU	Dose Units		text	2		Derived	Derived from ARM, ARMCD - equal to mg
EXDOSFRM	Dose Form		text	7	["TABLET" = "tab"] <Pharmaceutical Dosage Form>	CRF Page 20
EXSTDTC	Start Date/Time of Treatment	3	date		ISO8601	CRF Page 20
EXENDTC	End Date/Time of Treatment	4	date		ISO8601	CRF Page 20
EXSTDY	Study Day of Start of Treatment		integer	2		Derived	EXSTDY = EXSTDTC - RFSTDTC+1 if EXSTDTC is on or after RFSTDTC. EXSTDTC - RFSTDTC if EXSTDTC precedes RFSTDTC.
EXENDY	Study Day of End of Treatment		integer	2		Derived	EXENDY = EXENDTC-RFSTDTC+1 if EXENDTC is on or after RFSTDTC. EXENDTC - RFSTDTC if EXENDTC precedes RFSTDTC.
Related dataset: Supplemental Qualifiers for EX (SUPPEX)

Adverse Events (AE) [Location: ae.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["AE" = "Adverse Events"] <Domain Abbreviation (AE)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
AESEQ	Sequence Number		integer	1		Derived	Sequential number identifying records within each USUBJID in the domain.
AESPID	Sponsor-Defined Identifier		text	4		CRF Page 21
AETERM	Reported Term for the Adverse Event		text	25		CRF Page 21
AEMODIFY	Modified Reported Term		text	9		Assigned
AEDECOD	Dictionary-Derived Term	3	text	18	Adverse Event Dictionary	Assigned
AEBODSYS	Body System or Organ Class		text	52	Adverse Event Dictionary	Assigned
AESEV	Severity/Intensity		text	8	["MILD" = "Grade 1", "MODERATE" = "Grade 2", "SEVERE" = "Grade 3"] <Severity/Intensity Scale for Adverse Events>	CRF Page 21
AESER	Serious Event		text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	CRF Page 21
AEACN	Action Taken with Study Treatment		text	30	["DOSE NOT CHANGED", "DOSE REDUCED", "DRUG INTERRUPTED", "DRUG WITHDRAWN"] <Action Taken with Study Treatment>	CRF Page 21
AEREL	Causality		text	16	["NOT RELATED", "POSSIBLY RELATED", "RELATED"] <Causality>	CRF Page 21
AESTDTC	Start Date/Time of Adverse Event	4	date		ISO8601	CRF Page 21
AEENDTC	End Date/Time of Adverse Event		date		ISO8601	CRF Page 21
AESTDY	Study Day of Start of Adverse Event		integer	3		Derived	AESTDY = AESTDTC - RFSTDTC+1 if AESTDTC is on or after RFSTDTC. AESTDTC - RFSTDTC if AESTDTC precedes RFSTDTC
AEENDY	Study Day of End of Adverse Event		integer	3		Derived	AEENDY = AEENDTC -RFSTDTC+1 if AEENDTC is on or after RFSTDTC. AEENDTC - RFSTDTC if AEENDTC precedes RFSTDTC
AEENRF	End Relative to Reference Period		text	5	["AFTER"] <Relation to Reference Period (AEENRF)>	CRF Page 21
Related dataset: Supplemental Qualifiers for AE (SUPPAE)

Disposition (DS) [Location: ds.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["DS" = "Disposition"] <Domain Abbreviation (DS)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
DSSEQ	Sequence Number		integer	1		Derived	Sequential number identifying records within each USUBJID in the domain.
DSTERM	Reported Term for the Disposition Event		text	34	Reported Term for the Disposition Record	CRF Pages 6 16 18
DSDECOD	Standardized Disposition Term	6	text	21	Completion/Reason for Non-Completion	CRF Pages 6 16 18	CRF controlled terminology was mapped to match CDISC controlled terminology.
DSCAT	Category for Disposition Event	5	text	18	["DISPOSITION EVENT" = "Disposition Event", "PROTOCOL MILESTONE" = "Protocol Milestone"] <Category for Disposition Event>	Assigned
EPOCH	Epoch		text	9	["SCREEN", "TREATMENT"] <Epoch>	Assigned
DSSTDTC	Start Date/Time of Disposition Event	4	date		ISO8601	CRF Pages 6 16 18
DSSTDY	Study Day of Start of Disposition Event	3	integer	3		Derived	DSSTDY = DSSTDTC - RFSTDTC+1 if DSSTDTC is on or after RFSTDTC. DSSTDTC - RFSTDTC if DSSTDTC precedes RFSTDTC. Null if RFSTDTC is Null.

Medical History (MH) [Location: mh.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["MH" = "Medical History"] <Domain Abbreviation (MH)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
MHSEQ	Sequence Number		integer	1		Derived	Sequential number identifying records within each USUBJID in the domain.
MHTERM	Reported Term for the Medical History	4	text	169		CRF Pages 7 - 8
MHCAT	Category for Medical History	3	text	28	["MEDICAL AND SURGICAL HISTORY", "PSYCHIATRIC HISTORY"] <Category for Medical History>	CRF Pages 7 - 8
MHPRESP	Medical History Event Pre-Specified		text	2	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Assigned
MHOCCUR	Medical History Occurrence		text	2	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Assigned
MHBODSYS	Body System or Organ Class		text	23	Body System or Organ Class	Assigned	Assigned for Medical History but not Psychiatric History
MHDTC	Date/Time of History Collection	5	date		ISO8601	CRF Pages 7 - 8
MHSTDTC	Start Date/Time of Medical History Event	6	date		ISO8601	CRF Pages 7 - 8
MHENRF	End Relative to Reference Period		text	30	["BEFORE", "DURING/AFTER"] <Relation to Reference Period (MHENRF)>	CRF Page 8	CRF controlled terminology was mapped to match CDISC controlled terminology.

Drug Accountability (DA) [Location: da.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["DA" = "Drug Accountability"] <Domain Abbreviation (DA)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
DASEQ	Sequence Number		integer	1		Derived	Sequential number identifying records within each USUBJID in the domain.
DATESTCD	Short Name of Accountability Assessment	3	text	7	["DISPAMT" = "Dispensed Amount", "RETAMT" = "Returned Amount"] <Drug Accountability Test Code>	Assigned
DATEST	Name of Accountability Assessment		text	25	["Dispensed Amount", "Returned Amount"] <Drug Accountability Test Name>	CRF Page 19
DAORRES	Assessment Result in Original Units		text	2		CRF Page 19
DAORRESU	Original Units		text	7		CRF Page 19
DASTRESC	Assessment Result in Std Format		text	2		Derived	DASTRESC = DAORRES
DASTRESN	Numeric Result/Finding in Standard Units		integer	2		Derived	DASTRESN = numeric value of DAORRES, when DAORRES contains numeric data.
DASTRESU	Assessment Standard Units		text	7		Derived	DASTRESU = DAORRESU
VISITNUM	Visit Number		integer	2		Derived	Derived from DADTC and SVSTDTC.
VISIT	Visit Name		text	8		Assigned
VISITDY	Planned Study Day of Visit		integer	3		Protocol
DADTC	Date/Time of Accountability Assessment	4	date		ISO8601	CRF Page 19
DADY	Study Day of Accountability Assessment		integer	3		Derived	DADY = DADTC - RFSTDTC+1 if DADTC is on or after RFSTDTC. DADTC - RFSTDTC if DADTC precedes RFSTDTC.

ECG Test Results (EG) [Location: eg.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["EG" = "Electrocardiogram"] <Domain Abbreviation (EG)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
EGSEQ	Sequence Number		integer	2		Derived	Sequential number identifying records within each USUBJID in the domain.
EGSPID	Sponsor-Defined Identifier		text	6		Assigned	ECG parameter ordering variable
EGTESTCD	ECG Test or Examination Short Name	3	text	6	ECG Test Code	Assigned
EGTEST	ECG Test or Examination Name		text	40	ECG Test Name	CRF Page 12
EGPOS	ECG Position of Subject		text	6		Protocol	Equal to SUPINE
EGORRES	Result or Finding in Original Units		text	15		CRF Page 12
EGORRESU	Original Units		text	9	["BEATS/MIN" = "Beats per Minute", "msec" = "Millisecond"] <Unit (EGRESU)>	CRF Page 12
EGSTRESC	Character Result/Finding in Std Format		text	15		Derived	Data collected in non-standard units is converted using standard conversion factors to standard units.
EGSTRESN	Numeric Result/Finding in Standard Units		float	5		Derived	EGSTRESN = numeric value of EGSTRESC, when EGSTRESC contains numeric data.
EGSTRESU	Standard Units		text	9	["BEATS/MIN" = "Beats per Minute", "msec" = "Millisecond"] <Unit (EGRESU)>	Assigned
EGBLFL	Baseline Flag		text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Derived	Safety subjects only: EGBLFL = "Y" for last record with non Null EGORRES on or before the first dose date (RFSTDTC). Null otherwise
EGDRVFL	Derived Flag		text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Derived	EGDRVFL = "Y" for derived EGTESTCDs QTCB and QTCF. Null otherwise. Complex Algorithms (complexalgorithms.pdf)
EGEVAL	Evaluator		text	12		Assigned	Equal to INVESTIGATOR for CRF data
VISITNUM	Visit Number	5	integer	2		Assigned	Assigned from the TV domain based on the VISIT
VISIT	Visit Name		text	7		Assigned
VISITDY	Planned Study Day of Visit		integer	3		Protocol
EGDTC	Date/Time of ECG	4	date		ISO8601	CRF Page 12
EGDY	Study Day of ECG		integer	3		Derived	EGDY = EGDTC-RFSTDTC+1 if EGDTC is on or after RFTSDTC. EGDTC - RFSTDTC if EGDTC precedes RFSTDTC.
Related dataset: Supplemental Qualifiers for EG (SUPPEG)

Inclusion/Exclusion Criteria Not Met (IE) [Location: ie.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["IE" = "Inclusion/Exclusion"] <Domain Abbreviation (IE)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
IESEQ	Sequence Number		integer	1		Derived	Sequential number identifying records within each USUBJID in the domain.
IETESTCD	Inclusion/Exclusion Criterion Short Name	3	text	6	IE Test Codes	Assigned
IETEST	Inclusion/Exclusion Criterion		text	54	IE Tests	CRF Pages 4 - 5
IECAT	Inclusion/Exclusion Category		text	9		CRF Pages 4 - 5
IEORRES	I/E Criterion Original Result		text	1		CRF Pages 4 - 5
IESTRESC	I/E Criterion Result in Std Format		text	1		Derived	IESTRESC = IEORRES
VISITNUM	Visit Number		integer	1		Assigned	Assigned from the TV domain based on the VISIT
VISIT	Visit Name		text	6		Assigned
IEDTC	Date/Time of Collection		date		ISO8601	CRF Pages 4 - 5

Laboratory Tests Results (LB) [Location: lb.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["LB" = "Laboratory Data"] <Domain Abbreviation (LB)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
LBSEQ	Sequence Number		integer	2		Derived	Sequential number identifying records within each USUBJID in the domain.
LBREFID	Specimen ID		text	7		eDT	Accession number
LBTESTCD	Lab Test or Examination Short Name	5	text	7	Laboratory Test Code	Assigned
LBTEST	Lab Test or Examination Name		text	22	Laboratory Test Name	eDT
LBCAT	Category for Lab Test	3	text	10		eDT
LBORRES	Result or Finding in Original Units		text	8		eDT
LBORRESU	Original Units		text	7	Unit (LBRESU)	eDT
LBORNRLO	Reference Range Lower Limit in Orig Unit		text	8		eDT
LBORNRHI	Reference Range Upper Limit in Orig Unit		text	8		eDT
LBSTRESC	Character Result/Finding in Std Format		text	8		eDT
LBSTRESN	Numeric Result/Finding in Standard Units		float	5		eDT
LBSTRESU	Standard Units		text	7		eDT
LBSTNRLO	Reference Range Lower Limit-Std Units		float	4		eDT
LBSTNRHI	Reference Range Upper Limit-Std Units		float	4		eDT
LBSTNRC	Reference Range for Char Rslt-Std Units		text	19		eDT
LBNRIND	Reference Range Indicator		text	20	["ABNORMAL", "HIGH", "LOW", "NORMAL"] <Reference Range Indicator>	Derived	Reference Range Indicator based upon standard results and ranges.
LBSPEC	Specimen Type		text	5	["BLOOD", "SERUM", "URINE"] <Specimen Type>	eDT
LBMETHOD	Method of Test or Examination	4	text	8	["DIPSTICK", "QUANT"] <Method>	eDT
LBBLFL	Baseline Flag		text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Derived	Safety subjects only: LBBLFL = "Y" for last record with non Null LBORRES on or before the first dose date (RFSTDTC). Null otherwise.
LBFAST	Fasting Status		text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	eDT
VISITNUM	Visit Number	7	integer	2		eDT
VISIT	Visit Name		text	7		eDT
VISITDY	Planned Study Day of Visit		integer	3		Protocol
LBDTC	Date/Time of Specimen Collection	6	datetime		ISO8601	eDT
LBDY	Study Day of Specimen Collection		integer	3		Derived	LBDY = LBDTC-RFSTDTC+1 if LBDTC is on or after RFSTDTC. LBDTC - RFSTDTC if LBDTC precedes RFSTDTC.
Related dataset: Supplemental Qualifiers for LB (SUPPLB)

Physical Examination (PE) [Location: pe.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["PE" = "Physical Exam"] <Domain Abbreviation (PE)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
PESEQ	Sequence Number		integer	2		Derived	Sequential number identifying records within each USUBJID in the domain.
PETESTCD	Body System Examined Short Name	3	text	4	PE Test Codes	Assigned
PETEST	Body System Examined		text	29	PE Tests	CRF Page 10
PEORRES	Verbatim Examination Finding		text	36		CRF Page 10
PESTRESC	Character Result/Finding in Std Format		text	26		Derived	PESTRESC = PEORRES
VISITNUM	Visit Number	5	integer	2		Assigned	Assigned from the TV domain based on the VISIT
VISIT	Visit Name		text	7		Assigned
VISITDY	Planned Study Day of Visit		integer	3		Protocol
PEDTC	Date/Time of Examination	4	date		ISO8601	CRF Page 10
PEDY	Study Day of Examination		integer	3		Derived	PEDY = PEDTC-RFSTDTC+1 if PEDTC is on or after RFSTDTC. PEDTC - RFSTDTC if PEDTC precedes RFSTDTC.

Questionnaire-QSCG (QSCG) [Location: qscg.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["QS" = "Questionnaires"] <Domain Abbreviation (QS)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
QSSEQ	Sequence Number		integer	3		Derived	Sequential number identifying records within each USUBJID in the domain.
QSTESTCD	Question Short Name	4	text	7	QS Test Codes	Assigned
QSTEST	Question Name		text	37	QS Tests	CRF Page 17
QSCAT	Category of Question	3	text	50		CRF Page 17
QSORRES	Finding in Original Units		text	20		CRF Page 17
QSSTRESC	Character Result/Finding in Std Format		text	2		Derived	If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data.
QSSTRESN	Numeric Finding in Standard Units		integer	2		Derived	When QSORRES is numeric then QSSTRESN equal to numeric result
VISITNUM	Visit Number	6	integer	2		Assigned	Assigned from the TV domain based on the VISIT
VISIT	Visit Name		text	8		Assigned
VISITDY	Planned Study Day of Visit		integer	3		Protocol
QSDTC	Date/Time of Finding	5	date		ISO8601	CRF Page 17
QSDY	Study Day of Finding		integer	3		Derived	QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC.
Related dataset: Supplemental Qualifiers for QSCG (SUPPQSCG)

Questionnaire-QSCS (QSCS) [Location: qscs.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["QS" = "Questionnaires"] <Domain Abbreviation (QS)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
QSSEQ	Sequence Number		integer	3		Derived	Sequential number identifying records within each USUBJID in the domain.
QSTESTCD	Question Short Name	4	text	7	QS Test Codes	Assigned
QSTEST	Question Name		text	37	QS Tests	CRF Page 17
QSCAT	Category of Question	3	text	50		CRF Page 17
QSSCAT	Subcategory for Question		text	40		CRF Pages 14 - 15
QSORRES	Finding in Original Units		text	20		CRF Page 17
QSSTRESC	Character Result/Finding in Std Format		text	2		Derived	If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data.
QSSTRESN	Numeric Finding in Standard Units		integer	2		Derived	When QSORRES is numeric then QSSTRESN equal to numeric result
QSBLFL	Baseline Flag		text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Derived	Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise.
VISITNUM	Visit Number	6	integer	2		Assigned	Assigned from the TV domain based on the VISIT
VISIT	Visit Name		text	8		Assigned
VISITDY	Planned Study Day of Visit		integer	3		Protocol
QSDTC	Date/Time of Finding	5	date		ISO8601	CRF Page 17
QSDY	Study Day of Finding		integer	3		Derived	QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC.
QSEVLINT	Evaluation Interval		text	20		CRF Page 14
Related dataset: Supplemental Qualifiers for QSCS (SUPPQSCS)

Questionnaire-QSMM (QSMM) [Location: qsmm.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["QS" = "Questionnaires"] <Domain Abbreviation (QS)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
QSSEQ	Sequence Number		integer	3		Derived	Sequential number identifying records within each USUBJID in the domain.
QSTESTCD	Question Short Name	4	text	7	QS Test Codes	Assigned
QSTEST	Question Name		text	37	QS Tests	CRF Page 17
QSCAT	Category of Question	3	text	50		CRF Page 17
QSORRES	Finding in Original Units		text	20		CRF Page 17
QSSTRESC	Character Result/Finding in Std Format		text	2		Derived	If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data.
QSSTRESN	Numeric Finding in Standard Units		integer	2		Derived	When QSORRES is numeric then QSSTRESN equal to numeric result
QSBLFL	Baseline Flag		text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Derived	Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise.
VISITNUM	Visit Number	6	integer	2		Assigned	Assigned from the TV domain based on the VISIT
VISIT	Visit Name		text	8		Assigned
VISITDY	Planned Study Day of Visit		integer	3		Protocol
QSDTC	Date/Time of Finding	5	date		ISO8601	CRF Page 17
QSDY	Study Day of Finding		integer	3		Derived	QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC.
Related dataset: Supplemental Qualifiers for QSMM (SUPPQSMM)

Subject Characteristics (SC) [Location: sc.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["SC" = "Subject Characteristics"] <Domain Abbreviation (SC)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
SCSEQ	Sequence Number		integer	1		Derived	Sequential number identifying records within each USUBJID in the domain.
SCTESTCD	Subject Characteristic Short Name	3	text	8	["EDLEVEL" = "Education Level", "MARISTAT" = "Marital Status", "SUBJINIT" = "Subject Initials"] <Subject Characteristic Code (SCTESTCD)>	Assigned
SCTEST	Subject Characteristic		text	16	["Education Level", "Marital Status", "Subject Initials"] <SC Tests>	CRF Page 6
SCORRES	Result or Finding in Original Units		text	24		CRF Pages 3 6
SCSTRESC	Character Result/Finding in Std Format		text	24		Derived	SCSTRESC = SCORRES
SCDTC	Date/Time of Collection		date		ISO8601	CRF Page 6
SCDY	Study Day of Examination		integer	3		Derived	SCDY = SCDTC-RFSTDTC+1 if SCDTC is on or after RFSTDTC. SCDTC - RFSTDTC if SCDTC precedes RFSTDTC.

Vital Signs (VS) [Location: vs.xml]
Variable	Label	Key	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7		Protocol
DOMAIN	Domain Abbreviation		text	2	["VS" = "Vital Signs"] <Domain Abbreviation (VS)>	Assigned
USUBJID	Unique Subject Identifier	2	text	14		Derived	Concatenation of STUDYID and SUBJID
VSSEQ	Sequence Number		integer	2		Derived	Sequential number identifying records within each USUBJID in the domain.
VSTESTCD	Vital Signs Test Short Name	3	text	20	Vital Signs Test Code	Assigned
VSTEST	Vital Signs Test Name		text	24	Vital Signs Test Name	CRF Page 11
VSPOS	Vital Signs Position of Subject	6	text	7		CRF Page 11
VSORRES	Result or Finding in Original Units		text	30		CRF Page 11
VSORRESU	Original Units		text	20		CRF Page 11
VSSTRESC	Character Result/Finding in Std Format		text	30		Derived	Data collected in non-standard units (i.e. lbs, inches) is converted using standard conversion factors to standard units (kg, cm).
VSSTRESN	Numeric Result/Finding in Standard Units		float	5		Derived	VSSTRESN = numeric value of VSSTRESC, when VSSTRESC contains numeric data.
VSSTRESU	Standard Units		text	9	["BEATS/MIN" = "Beats per Minute", "cm" = "Centimeter", "kg" = "Kilogram", "mmHg" = "Millimeter of Mercury"] <Units for Vital Signs Results>	Assigned	Standard units consistent with CDISC controlled terminology
VSBLFL	Baseline Flag		text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Derived	Safety subjects only: VSBLFL = "Y" for last record with non Null VSORRES on or before the first dose date (RFSTDTC). Null otherwise.
VISITNUM	Visit Number	5	integer	2		Assigned	Assigned from the TV domain based on the VISIT
VISIT	Visit Name		text	8		Assigned
VISITDY	Planned Study Day of Visit		integer	3		Protocol
VSDTC	Date/Time of Measurements	4	date		ISO8601	CRF Page 11
VSDY	Study Day of Vital Signs		integer	3		Derived	VSDY = VSDTC-RFSTDTC+1 if VSDTC is on or after RFSTDTC. VSDTC - RFSTDTC if VSDTC precedes RFSTDTC.
Related dataset: Supplemental Qualifiers for VS (SUPPVS)

Related Records (RELREC) [Location: relrec.xml]
Variable	Label	Key	Type	Length	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7	Protocol
RDOMAIN	Related Domain Abbreviation	2	text	2	Derived	Domain abbreviation from where data originated.
USUBJID	Unique Subject Identifier	3	text	14	Derived	Concatenation of STUDYID and SUBJID
IDVAR	Identifying Variable	4	text	8	Assigned	Name of the variables for the related records.
IDVARVAL	Identifying Variable Value	5	text	2	Assigned	Value of identifying variable described in IDVAR.
RELTYPE	Relationship Type		text	4	Assigned	All values are null since this is used only when identifying a dataset-level relationship.
RELID	Relationship Identifier	6	text	10	Derived	All records for the same USUBJID with the same RELID are considered related.

Supplemental Qualifiers for AE (SUPPAE) [Location: suppae.xml]
Variable	Label	Key	Type	Length	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7	Protocol
RDOMAIN	Related Domain Abbreviation	2	text	2	Derived	Domain abbreviation from where data originated.
USUBJID	Unique Subject Identifier	3	text	14	Derived	Concatenation of STUDYID and SUBJID
IDVAR	Identifying Variable	4	text	5	Assigned	Name of the variables for the related records.
IDVARVAL	Identifying Variable Value	5	text	1	Assigned	Value of identifying variable described in IDVAR.
QNAM	Qualifier Variable Name	6	text	7	Assigned
QLABEL	Qualifier Variable Label		text	30	Assigned
QVAL	Data Value		text	60
QORIG	Origin		text	8	Assigned
QEVAL	Evaluator		text	30	Assigned
Related dataset: Adverse Events (AE)

Supplemental Qualifiers for CM (SUPPCM) [Location: suppcm.xml]
Variable	Label	Key	Type	Length	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7	Protocol
RDOMAIN	Related Domain Abbreviation	2	text	2	Derived	Domain abbreviation from where data originated.
USUBJID	Unique Subject Identifier	3	text	14	Derived	Concatenation of STUDYID and SUBJID
IDVAR	Identifying Variable	4	text	5	Assigned	Name of the variables for the related records.
IDVARVAL	Identifying Variable Value	5	text	2	Assigned	Value of identifying variable described in IDVAR.
QNAM	Qualifier Variable Name	6	text	8	Assigned
QLABEL	Qualifier Variable Label		text	26	Assigned
QVAL	Data Value		text	43
QORIG	Origin		text	10	Assigned
QEVAL	Evaluator		text	30	Assigned
Related dataset: Concomitant Medications (CM)

Supplemental Qualifiers for DM (SUPPDM) [Location: suppdm.xml]
Variable	Label	Key	Type	Length	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7	Protocol
RDOMAIN	Related Domain Abbreviation	2	text	2	Derived	Domain abbreviation from where data originated.
USUBJID	Unique Subject Identifier	3	text	14	Derived	Concatenation of STUDYID and SUBJID
IDVAR	Identifying Variable	4	text	1	Assigned	Name of the variables for the related records.
IDVARVAL	Identifying Variable Value	5	text	1	Assigned	Value of identifying variable described in IDVAR.
QNAM	Qualifier Variable Name	6	text	8	Assigned
QLABEL	Qualifier Variable Label		text	26	Assigned
QVAL	Data Value		text	30
QORIG	Origin		text	11	Assigned
QEVAL	Evaluator		text	30	Assigned
Related dataset: Demographics (DM)

Supplemental Qualifiers for EG (SUPPEG) [Location: suppeg.xml]
Variable	Label	Key	Type	Length	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7	Protocol
RDOMAIN	Related Domain Abbreviation	2	text	2	Derived	Domain abbreviation from where data originated.
USUBJID	Unique Subject Identifier	3	text	14	Derived	Concatenation of STUDYID and SUBJID
IDVAR	Identifying Variable	4	text	5	Assigned	Name of the variables for the related records.
IDVARVAL	Identifying Variable Value	5	text	2	Assigned	Value of identifying variable described in IDVAR.
QNAM	Qualifier Variable Name	6	text	7	Assigned
QLABEL	Qualifier Variable Label		text	36	Assigned
QVAL	Data Value		text	2
QORIG	Origin		text	7	Assigned
QEVAL	Evaluator		text	30	Assigned
Related dataset: ECG Test Results (EG)

Supplemental Qualifiers for EX (SUPPEX) [Location: suppex.xml]
Variable	Label	Key	Type	Length	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7	Protocol
RDOMAIN	Related Domain Abbreviation	2	text	2	Derived	Domain abbreviation from where data originated.
USUBJID	Unique Subject Identifier	3	text	14	Derived	Concatenation of STUDYID and SUBJID
IDVAR	Identifying Variable	4	text	5	Assigned	Name of the variables for the related records.
IDVARVAL	Identifying Variable Value	5	text	1	Assigned	Value of identifying variable described in IDVAR.
QNAM	Qualifier Variable Name	6	text	4	Assigned
QLABEL	Qualifier Variable Label		text	25	Assigned
QVAL	Data Value		text	2
QORIG	Origin		text	11	Assigned
QEVAL	Evaluator		text	30	Assigned
Related dataset: Exposure (EX)

Supplemental Qualifiers for LB (SUPPLB) [Location: supplb.xml]
Variable	Label	Key	Type	Length	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7	Protocol
RDOMAIN	Related Domain Abbreviation	2	text	2	Derived	Domain abbreviation from where data originated.
USUBJID	Unique Subject Identifier	3	text	14	Derived	Concatenation of STUDYID and SUBJID
IDVAR	Identifying Variable	4	text	5	Assigned	Name of the variables for the related records.
IDVARVAL	Identifying Variable Value	5	text	2	Assigned	Value of identifying variable described in IDVAR.
QNAM	Qualifier Variable Name	6	text	7	Assigned
QLABEL	Qualifier Variable Label		text	36	Assigned
QVAL	Data Value		text	2
QORIG	Origin		text	7	Assigned
QEVAL	Evaluator		text	30	Assigned
Related dataset: Laboratory Tests Results (LB)

Supplemental Qualifiers for QSCG (SUPPQSCG) [Location: suppqscg.xml]
Variable	Label	Key	Type	Length	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7	Protocol
RDOMAIN	Related Domain Abbreviation	2	text	2	Derived	Domain abbreviation from where data originated.
USUBJID	Unique Subject Identifier	3	text	14	Derived	Concatenation of STUDYID and SUBJID
IDVAR	Identifying Variable	4	text	5	Assigned	Name of the variables for the related records.
IDVARVAL	Identifying Variable Value	5	text	50	Assigned	Value of identifying variable described in IDVAR.
QNAM	Qualifier Variable Name	6	text	7	Assigned
QLABEL	Qualifier Variable Label		text	36	Assigned
QVAL	Data Value		text	3
QORIG	Origin		text	7	Assigned
QEVAL	Evaluator		text	30	Assigned
Related dataset: Questionnaire-QSCG (QSCG)

Supplemental Qualifiers for QSCS (SUPPQSCS) [Location: suppqscs.xml]
Variable	Label	Key	Type	Length	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7	Protocol
RDOMAIN	Related Domain Abbreviation	2	text	2	Derived	Domain abbreviation from where data originated.
USUBJID	Unique Subject Identifier	3	text	14	Derived	Concatenation of STUDYID and SUBJID
IDVAR	Identifying Variable	4	text	5	Assigned	Name of the variables for the related records.
IDVARVAL	Identifying Variable Value	5	text	50	Assigned	Value of identifying variable described in IDVAR.
QNAM	Qualifier Variable Name	6	text	7	Assigned
QLABEL	Qualifier Variable Label		text	36	Assigned
QVAL	Data Value		text	3
QORIG	Origin		text	7	Assigned
QEVAL	Evaluator		text	30	Assigned
Related dataset: Questionnaire-QSCS (QSCS)

Supplemental Qualifiers for QSMM (SUPPQSMM) [Location: suppqsmm.xml]
Variable	Label	Key	Type	Length	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7	Protocol
RDOMAIN	Related Domain Abbreviation	2	text	2	Derived	Domain abbreviation from where data originated.
USUBJID	Unique Subject Identifier	3	text	14	Derived	Concatenation of STUDYID and SUBJID
IDVAR	Identifying Variable	4	text	5	Assigned	Name of the variables for the related records.
IDVARVAL	Identifying Variable Value	5	text	50	Assigned	Value of identifying variable described in IDVAR.
QNAM	Qualifier Variable Name	6	text	7	Assigned
QLABEL	Qualifier Variable Label		text	36	Assigned
QVAL	Data Value		text	3
QORIG	Origin		text	7	Assigned
QEVAL	Evaluator		text	30	Assigned
Related dataset: Questionnaire-QSMM (QSMM)

Supplemental Qualifiers for VS (SUPPVS) [Location: suppvs.xml]
Variable	Label	Key	Type	Length	Origin	Derivation/Comment
STUDYID	Study Identifier	1	text	7	Protocol
RDOMAIN	Related Domain Abbreviation	2	text	2	Derived	Domain abbreviation from where data originated.
USUBJID	Unique Subject Identifier	3	text	14	Derived	Concatenation of STUDYID and SUBJID
IDVAR	Identifying Variable	4	text	5	Assigned	Name of the variables for the related records.
IDVARVAL	Identifying Variable Value	5	text	2	Assigned	Value of identifying variable described in IDVAR.
QNAM	Qualifier Variable Name	6	text	7	Assigned
QLABEL	Qualifier Variable Label		text	36	Assigned
QVAL	Data Value		text	2
QORIG	Origin		text	7	Assigned
QEVAL	Evaluator		text	30	Assigned
Related dataset: Vital Signs (VS)

Value Level Metadata

Value Level Metadata - DA [DAORRES]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
DAORRES	DATESTCD EQ DISPAMT (Dispensed Amount)	integer	2		CRF Page 19
DAORRES	DATESTCD EQ RETAMT (Returned Amount)	integer	2		CRF Page 19

Value Level Metadata - EG [EGORRES]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin
EGORRES	EGTESTCD EQ INTP (Interpretation)	text	8	["ABNORMAL", "NORMAL"] <Interpretation: Original Results>	CRF Page 12
EGORRES	EGTESTCD EQ PRMEAN (Summary (Mean) PR Duration)	integer	3		CRF Page 12
EGORRES	EGTESTCD EQ QRSDUR (Summary (Mean) QRS Duration)	integer	3		CRF Page 12
EGORRES	EGTESTCD EQ QTMEAN (Summary (Mean) QT Duration)	integer	3		CRF Page 12
EGORRES	EGTESTCD EQ VRMEAN (Summary (Mean) Ventricular Rate)	integer	2		CRF Page 12

Value Level Metadata - EG [EGSTRESC]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
EGSTRESC	EGTESTCD EQ QTCB (QTcB - Bazett's Correction Formula)	float	5.1		Derived	QTcB = QT interval / square root of (60 / heart rate). For the complete algorithm see the referenced external document. Complex Algorithms (complexalgorithms.pdf)
EGSTRESC	EGTESTCD EQ QTCF (QTcF - Fridericia's Correction Formula)	float	5.1		Derived	QTcF = QT interval / cubic root of (60 / heart rate). For the complete algorithm see the referenced external document. Complex Algorithms (complexalgorithms.pdf)

Value Level Metadata - IE [IEORRES]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin
IEORRES	IETESTCD EQ EXCL01 (Is pregnant, nursing, or planning to become pregnant within 6 months of last study treatment)	text	200	["Y" = "Yes", "N" = "No", "NA" = "Not Applicable"] <No Yes Response>	CRF Page 5
IEORRES	IETESTCD EQ EXCL02 (Is unable or unwilling to undergo multiple venipunctures)	text	200	["Y" = "Yes", "N" = "No", "NA" = "Not Applicable"] <No Yes Response>	CRF Page 5
IEORRES	IETESTCD EQ EXCL03 (Is known to have had a substance abuse (drug or alcohol) problem within the previous 3 years)	text	200	["Y" = "Yes", "N" = "No", "NA" = "Not Applicable"] <No Yes Response>	CRF Page 5
IEORRES	IETESTCD EQ INCL01 (Is age 18 - 85)	text	200	["Y" = "Yes", "N" = "No", "NA" = "Not Applicable"] <No Yes Response>	CRF Page 4
IEORRES	IETESTCD EQ INCL02 (Has Xyz disease of at least 10 weeks duration confirmed by biopsy)	text	200	["Y" = "Yes", "N" = "No", "NA" = "Not Applicable"] <No Yes Response>	CRF Page 4
IEORRES	IETESTCD EQ INCL03 (Did not respond to a standard course of medication Abc)	text	200	["Y" = "Yes", "N" = "No", "NA" = "Not Applicable"] <No Yes Response>	CRF Page 4

Value Level Metadata - LB [LBORRES]
Variable	Where	Type	Length / Display Format	Origin
LBORRES	LBTESTCD EQ BILI (Bilirubin) AND LBCAT EQ CHEMISTRY AND LBSPEC EQ BLOOD	float	3	eDT
LBORRES	LBTESTCD EQ BUN (Blood Urea Nitrogen) AND LBCAT EQ CHEMISTRY AND LBSPEC EQ BLOOD	float	4	eDT
LBORRES	LBTESTCD EQ GLUC (Glucose) AND LBCAT EQ CHEMISTRY AND LBSPEC EQ BLOOD	float	3	eDT
LBORRES	LBTESTCD EQ GLUC (Glucose) AND LBCAT EQ URINALYSIS AND LBSPEC EQ URINE AND LBMETHOD EQ DIPSTICK	text	8	eDT
LBORRES	LBTESTCD EQ GLUC (Glucose) AND LBCAT EQ URINALYSIS AND LBSPEC EQ URINE AND LBMETHOD EQ QUANT	text	8	eDT
LBORRES	LBTESTCD EQ HCT (Hematocrit) AND LBCAT EQ HEMATOLOGY AND LBSPEC EQ BLOOD	float	4	eDT
LBORRES	LBTESTCD EQ HGB (Hemoglobin) AND LBCAT EQ HEMATOLOGY AND LBSPEC EQ BLOOD	float	4	eDT
LBORRES	LBTESTCD EQ LYM (Lymphocytes) AND LBCAT EQ HEMATOLOGY AND LBSPEC EQ BLOOD	float	4	eDT
LBORRES	LBTESTCD EQ OCCBLD (Occult Blood) AND LBCAT EQ URINALYSIS AND LBSPEC EQ URINE	text	8	eDT
LBORRES	LBTESTCD EQ PH (pH) AND LBCAT EQ URINALYSIS AND LBSPEC EQ URINE	float	3	eDT
LBORRES	LBTESTCD EQ VITB12 (Vitamin B12) AND LBCAT EQ CHEMISTRY AND LBSPEC EQ SERUM	integer	3	eDT
LBORRES	LBTESTCD EQ VITB9 (Vitamin B9) AND LBCAT EQ CHEMISTRY AND LBSPEC EQ BLOOD	float	5	eDT

Value Level Metadata - PE [PEORRES]
Variable	Where	Type	Length / Display Format	Origin
PEORRES	PETESTCD EQ PE01 (Appearance/Skin)	text	16	CRF Page 10
PEORRES	PETESTCD EQ PE02 (Head/Neck (Including Thyroid))	text	6	CRF Page 10
PEORRES	PETESTCD EQ PE03 (Eyes-Ears-Nose-Throat)	text	13	CRF Page 10
PEORRES	PETESTCD EQ PE04 (Cardiovascular)	text	20	CRF Page 10
PEORRES	PETESTCD EQ PE05 (Pulmonary)	text	6	CRF Page 10
PEORRES	PETESTCD EQ PE06 (Abdomen)	text	6	CRF Page 10
PEORRES	PETESTCD EQ PE07 (Neurological)	text	26	CRF Page 10
PEORRES	PETESTCD EQ PE08 (Musculoskeletal)	text	6	CRF Page 10
PEORRES	PETESTCD EQ PE09 (Other)	text	19	CRF Page 10

Value Level Metadata - QSCG [QSORRES]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin
QSORRES	QSTESTCD EQ CGIGLOB (Global Improvement)	integer	1	Global Improvement	CRF Page 17
QSORRES	QSTESTCD EQ CSDD01 (Anxiety)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 14
QSORRES	QSTESTCD EQ CSDD02 (Sadness)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 14
QSORRES	QSTESTCD EQ CSDD03 (Lack of Reactivity to Pleasant Events)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 14
QSORRES	QSTESTCD EQ CSDD04 (Irritability)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 14
QSORRES	QSTESTCD EQ CSDD05 (Agitation)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 14
QSORRES	QSTESTCD EQ CSDD06 (Retardation)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 14
QSORRES	QSTESTCD EQ CSDD07 (Multiple Physical Complaints)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 14
QSORRES	QSTESTCD EQ CSDD08 (Loss of Interest)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 14
QSORRES	QSTESTCD EQ CSDD09 (Appetite Loss)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 15
QSORRES	QSTESTCD EQ CSDD10 (Weight Loss)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 15
QSORRES	QSTESTCD EQ CSDD11 (Lack of Energy)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 15
QSORRES	QSTESTCD EQ CSDD12 (Diurnal Variation of Mood)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 15
QSORRES	QSTESTCD EQ CSDD13 (Difficulty Falling Asleep)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 15
QSORRES	QSTESTCD EQ CSDD14 (Multiple Awakenings During Sleep)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 15
QSORRES	QSTESTCD EQ CSDD15 (Early Morning Awakening)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 15
QSORRES	QSTESTCD EQ CSDD16 (Suicide)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 15
QSORRES	QSTESTCD EQ CSDD17 (Poor Self-Esteem)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 15
QSORRES	QSTESTCD EQ CSDD18 (Pessimism)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 15
QSORRES	QSTESTCD EQ CSDD19 (Mood-Congruent Delusions)	integer	1	["0" = "Absent", "1" = "Mild or Intermittent", "2" = "Severe"] <CUE_EXPF_X>	CRF Page 15
QSORRES	QSTESTCD EQ CSDDTOT (Total Score)	integer	2		CRF Page 15
QSORRES	QSTESTCD EQ MMSEA1 (Orientation time score)	integer	1		CRF Page 13
QSORRES	QSTESTCD EQ MMSEA2 (Orientation place score)	integer	1		CRF Page 13
QSORRES	QSTESTCD EQ MMSEB (Registration)	integer	1		CRF Page 13
QSORRES	QSTESTCD EQ MMSEC (Attention and Calculation)	integer	1		CRF Page 13
QSORRES	QSTESTCD EQ MMSED (Recall)	integer	1		CRF Page 13
QSORRES	QSTESTCD EQ MMSEET (Language)	integer	1		CRF Page 13
QSORRES	QSTESTCD EQ MMSETOT (Total Score)	integer	2		CRF Page 13

Value Level Metadata - SC [SCORRES]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin
SCORRES	SCTESTCD EQ EDLEVEL (Education Level)	text	24		CRF Page 6
SCORRES	SCTESTCD EQ MARISTAT (Marital Status)	text	17	Marital Status	CRF Page 6
SCORRES	SCTESTCD EQ SUBJINIT (Subject Initials)	text	3		CRF Page 3

Value Level Metadata - SUPPAE [QVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
QVAL	QNAM EQ AETRTEM (Treatment Emergent Flag)	text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Derived	AETRTEM = "Y" if Adverse Event was not present prior to the RFSTDTC, or it was present prior to the RFSTDTC but increased in severity during the treatment period. Null otherwise.
QVAL	QNAM EQ HLGT (High Level Group Term)	text	52	Adverse Event Dictionary	Assigned
QVAL	QNAM EQ HLT (High Level Term)	text	60	Adverse Event Dictionary	Assigned
QVAL	QNAM EQ LLT (Lowest Level Term)	text	18	Adverse Event Dictionary	Assigned

Value Level Metadata - SUPPCM [QVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin
QVAL	QNAM EQ ATC4CODE (WHODRUG ATC Level 4 Code)	text	5	Drug Dictionary	Assigned
QVAL	QNAM EQ ATC4TERM (ATC4 Drug Class Term)	text	43	Drug Dictionary	Assigned
QVAL	QNAM EQ CPREFCD (WHODRUG Drug Code)	text	11	Drug Dictionary	Assigned
QVAL	QNAM EQ PDDREAS (Reason for Discontinuation)	text	21	Reason for Discontinuation	CRF Page 9
QVAL	QNAM EQ PDRESP (Response)	text	4	["GOOD", "NO CHANGE", "POOR"] <PSRESPF>	CRF Page 9

Value Level Metadata - SUPPDM [QVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
QVAL	QNAM EQ RACE1 (Race 1)	text	5	Race	CRF Page 6
QVAL	QNAM EQ RACE2 (Race 2)	text	25	Race	CRF Page 6
QVAL	QNAM EQ RACE3 (Race 3)	text	5	Race	CRF Page 6
QVAL	QNAM EQ RACEOTH (Race, Other)	text	14		CRF Page 6
QVAL	QNAM EQ RAND (Randomized Population Flag)	text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	CRF Page 16
QVAL	QNAM EQ RANDNO (Randomization Number)	text	4		CRF Page 16
QVAL	QNAM EQ SAFETY (Safety Population Flag)	text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Derived	SAFETY = "Y" for randomized subjects who took at least one dose study medication. Null otherwise.

Value Level Metadata - SUPPEG [QVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
QVAL	QNAM EQ EGCLSIG (Clinically Significant)	text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	CRF Page 12

Value Level Metadata - SUPPEX [QVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
QVAL	QNAM EQ SMNO (Number of Tablets Per Day)	integer	2		CRF Page 20

Value Level Metadata - SUPPLB [QVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
QVAL	QNAM EQ LBCLSIG (Clinically Significant)	text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Derived	Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan.

Value Level Metadata - SUPPQSCG [QVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
QVAL	QNAM EQ RTRINIT (Rater Initials)	text	3		CRF Pages 13 14 17	QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17

Value Level Metadata - SUPPVS [QVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
QVAL	QNAM EQ VSCLSIG (Clinically Significant)	text	1	["Y" = "Yes", "N" = "No", "U" = "Unknown"] <No Yes Response Subset>	Derived	Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan.

Value Level Metadata - TS [TSVAL]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin
TSVAL	TSPARMCD EQ AGEMAX (Planned Maximum Age of Subjects)	integer	2		Protocol
TSVAL	TSPARMCD EQ AGEMIN (Planned Minimum Age of Subjects)	integer	2		Protocol
TSVAL	TSPARMCD EQ AGEU (Age Unit)	text	57	["YEARS"] <Age Unit>	Protocol
TSVAL	TSPARMCD EQ DOSE (Dose per Administration)	integer	2		Protocol
TSVAL	TSPARMCD EQ PLANSUB (Planned Number of Subjects)	integer	2		Protocol

Value Level Metadata - VS [VSORRES]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin
VSORRES	VSTESTCD EQ DIABP (Diastolic Blood Pressure)	integer	2		CRF Page 11
VSORRES	VSTESTCD EQ FRMSIZE (Body Frame Size)	text	6	["SMALL", "MEDIUM", "LARGE"] <Size>	CRF Page 11
VSORRES	VSTESTCD EQ HEIGHT (Height)	float	5.1		CRF Page 11
VSORRES	VSTESTCD EQ PULSE (Pulse Rate)	integer	2		CRF Page 11
VSORRES	VSTESTCD EQ SYSBP (Systolic Blood Pressure)	integer	3		CRF Page 11
VSORRES	VSTESTCD EQ WEIGHT (Weight)	float	5.1		CRF Page 11

Value Level Metadata - VS [VSORRESU]
Variable	Where	Type	Length / Display Format	Controlled Terms or Format	Origin	Derivation/Comment
VSORRESU	VSTESTCD EQ HEIGHT (Height) AND COUNTRY IN ( "CAN" , "MEX" )	text	5	["cm" = "Centimeter"] <Unit (UH_MC)>	CRF Page 11	Join any Subject Level dataset with the Demographics dataset based on [IG.datasetname]IT.USUBJID = [IG.DM]IT.USUBJID, assuming 'IG.datasetname' is the OID of the ItemGroupDef that defines the subject-level dataset to be joined with the Demographics dataset. The data submitted only includes subjects in the USA since other sites did not enroll any subjects.
VSORRESU	VSTESTCD EQ HEIGHT (Height) AND COUNTRY EQ USA	text	5	["IN" = "Inch"] <Unit (UH_NMC)>	CRF Page 11	Join any Subject Level dataset with the Demographics dataset based on [IG.datasetname]IT.USUBJID = [IG.DM]IT.USUBJID, assuming 'IG.datasetname' is the OID of the ItemGroupDef that defines the subject-level dataset to be joined with the Demographics dataset.
VSORRESU	VSTESTCD EQ WEIGHT (Weight) AND COUNTRY IN ( "CAN" , "MEX" )	text	4	["kg" = "Kilogram"] <Unit (UW_MC)>	CRF Page 11	Join any Subject Level dataset with the Demographics dataset based on [IG.datasetname]IT.USUBJID = [IG.DM]IT.USUBJID, assuming 'IG.datasetname' is the OID of the ItemGroupDef that defines the subject-level dataset to be joined with the Demographics dataset. The data submitted only includes subjects in the USA since other sites did not enroll any subjects.
VSORRESU	VSTESTCD EQ WEIGHT (Weight) AND COUNTRY EQ USA	text	4	["LB" = "Pound"] <Unit (UW_NMC)>	CRF Page 11	Join any Subject Level dataset with the Demographics dataset based on [IG.datasetname]IT.USUBJID = [IG.DM]IT.USUBJID, assuming 'IG.datasetname' is the OID of the ItemGroupDef that defines the subject-level dataset to be joined with the Demographics dataset.

Controlled Terms

Action Taken with Study Treatment [CL.ACN, C66767]
Permitted Value (Code)
DOSE NOT CHANGED [C49504]
DOSE REDUCED [C49505]
DRUG INTERRUPTED [C49501]
DRUG WITHDRAWN [C49502]

Domain Abbreviation (AE) [CL.AE.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
AE [C49562]	Adverse Events

Relation to Reference Period (AEENRF) [CL.AEENRF, C66728]
Permitted Value (Code)
AFTER [C38008]

Causality [CL.AEREL]
Permitted Value (Code)
NOT RELATED
POSSIBLY RELATED
RELATED

Severity/Intensity Scale for Adverse Events [CL.AESEV, C66769]
Permitted Value (Code)	Display Value (Decode)
MILD [C41338]	Grade 1
MODERATE [C41339]	Grade 2
SEVERE [C41340]	Grade 3

Age Unit [CL.AGEU, C66781]
Permitted Value (Code)
YEARS [C29848]

Description of Planned Arm [CL.ARM]
Permitted Value (Code)
Miracle Drug 10 mg
Miracle Drug 20 mg
Placebo
Screen Failure

Planned Arm Code [CL.ARMCD]
Permitted Value (Code)	Display Value (Decode)
WONDER10	Miracle Drug 10 mg
WONDER20	Miracle Drug 20 mg
PLACEBO	Placebo
SCRNFAIL	Screen Failure

Global Improvement [CL.CGIIMP_X]
Permitted Value (Code)	Display Value (Decode)
1	Very much improved
2	Much Improved
3	Minimally Improved
4	No change
5	Minimally worse
6	Much worse
7	Very much worse

Domain Abbreviation (CM) [CL.CM.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
CM [C49568]	Concomitant Meds

Category for Medication [CL.CMCAT]
Permitted Value (Code)
CONCOMITANT MEDICATIONS
PSYCHOTROPHIC DRUG TREATMENT HISTORY

Relation to Reference Period (CMENRF) [CL.CMENRF, C66728]
Permitted Value (Code)
AFTER [C38008]

Unit (CM) [CL.CMUNIT, C71620]
Permitted Value (Code)	Display Value (Decode)
CAPSULE [C48480]	Capsule Dosing Unit
IU [C48579]	International Unit
TABLET [C48542]	Tablet Dosing Unit
VIAL [C48551]	Vial Dosing Unit
g [C48155]	Gram
mL [C28254]	Milliliter
mL/hr [*]	mL/hr
mL/kg [C67411]	Milliliter per Kilogram
mg [C28253]	Milligram
mg/kg [C67401]	Milligram per Kilogram
ug [C48152]	Microgram
ug/kg [C67396]	mcg/kg
Other [*]	Other

* Extended Value

CUE_EXPF_X [CL.CUE_EXPF_X]
Permitted Value (Code)	Display Value (Decode)
0	Absent
1	Mild or Intermittent
2	Severe

Domain Abbreviation (DA) [CL.DA.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
DA [C49578]	Drug Accountability

Drug Accountability Test Name [CL.DATEST, C78731]
Permitted Value (Code)
Dispensed Amount [C78721]
Returned Amount [C78722]

Drug Accountability Test Code [CL.DATESTCD, C78732]
Permitted Value (Code)	Display Value (Decode)
DISPAMT [C78721]	Dispensed Amount
RETAMT [C78722]	Returned Amount

Reason for Discontinuation [CL.DDISCNTF]
Permitted Value (Code)
ONGOING
ADVERSE EVENT
INSUFFICIENT RESPONSE
SATISFACTORY RESPONSE
OTHER

Domain Abbreviation (DM) [CL.DM.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
DM [C49572]	Demographics

Domain Abbreviation (DS) [CL.DS.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
DS [C49576]	Disposition

Category for Disposition Event [CL.DSCAT, C74558]
Permitted Value (Code)	Display Value (Decode)
DISPOSITION EVENT [C74590]	Disposition Event
PROTOCOL MILESTONE [C74588]	Protocol Milestone

Domain Abbreviation (EG) [CL.EG.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
EG [C49626]	Electrocardiogram

Unit (EGRESU) [CL.EGRESU, C71620]
Permitted Value (Code)	Display Value (Decode)
BEATS/MIN [C49673]	Beats per Minute
msec [C41140]	Millisecond

ECG Test Name [CL.EGTEST, C71152]
Permitted Value (Code)
Interpretation [C41255]
QTcB - Bazett's Correction Formula [C62112]
QTcF - Fridericia's Correction Formula [C62113]
Summary (Mean) PR Duration [C62086]
Summary (Mean) QRS Duration [C62087]
Summary (Mean) QT Duration [C62089]
Summary (Mean) Ventricular Rate [C62152]

ECG Test Code [CL.EGTESTCD, C71153]
Permitted Value (Code)	Display Value (Decode)
INTP [C41255]	Interpretation
PRMEAN [C62086]	Summary (Mean) PR Duration
QRSDUR [C62087]	Summary (Mean) QRS Duration
QTCB [C62112]	QTcB - Bazett's Correction Formula
QTCF [C62113]	QTcF - Fridericia's Correction Formula
QTMEAN [C62089]	Summary (Mean) QT Duration
VRMEAN [C62152]	Summary (Mean) Ventricular Rate

Epoch [CL.EPOCH, C99079]
Permitted Value (Code)
SCREEN [*]
TREATMENT [C49236]

* Extended Value

Ethnic Group [CL.ETHNIC, C66790]
Permitted Value (Code)
HISPANIC OR LATINO [C17459]
NOT HISPANIC OR LATINO [C41222]

Domain Abbreviation (EX) [CL.EX.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
EX [C49587]	Exposure

Treatment [CL.EXTRT]
Permitted Value (Code)
Miracle Drug
Placebo

Frequency [CL.FREQ, C71113]
Permitted Value (Code)	Display Value (Decode)
BID [C64496]	BD
ONCE [C64576]	Once
PRN [C64499]	As needed
Q24H [C64515]	Every 24 hours
QID [C64530]	4 times per day
QOD [C64525]	Every other day
QS [C67069]	Every week
TID [C64527]	3 times per day
OTHER [C17649]	Other

Pharmaceutical Dosage Form [CL.FRM, C66726]
Permitted Value (Code)	Display Value (Decode)
TABLET [C42998]	tab

Domain Abbreviation (IE) [CL.IE.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
IE [C61536]	Inclusion/Exclusion

IE Tests [CL.IETEST]
Permitted Value (Code)
Did not respond to a standard course of medication Abc
Has Xyz disease of at least 10 weeks duration confirmed by biopsy
Is age 18 - 85
Is known to have had a substance abuse (drug or alcohol) problem within the previous 3 years
Is pregnant, nursing, or planning to become pregnant within 6 months of last study treatment
Is unable or unwilling to undergo multiple venipunctures

IE Test Codes [CL.IETESTCD]
Permitted Value (Code)	Display Value (Decode)
EXCL01	Is pregnant, nursing, or planning to become pregnant within 6 months of last study treatment
EXCL02	Is unable or unwilling to undergo multiple venipunctures
EXCL03	Is known to have had a substance abuse (drug or alcohol) problem within the previous 3 years
INCL01	Is age 18 - 85
INCL02	Has Xyz disease of at least 10 weeks duration confirmed by biopsy
INCL03	Did not respond to a standard course of medication Abc

Domain Abbreviation (LB) [CL.LB.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
LB [C49592]	Laboratory Data

Unit (LBRESU) [CL.LBRESU, C71620]
Permitted Value (Code)	Display Value (Decode)
% [C25613]	Percentage
X10^9/L [*]	X10^9/L
g/dL [C64783]	Gram per Deciliter
mg/dL [C67015]	Milligram per Deciliter
ng/dL [C67326]	Nanogram per Deciliter
pg/mL [*]	pg/mL

* Extended Value

Laboratory Test Name [CL.LBTEST, C67154]
Permitted Value (Code)
Bilirubin [C38037]
Blood Urea Nitrogen [C61019]
Glucose [C41376]
Hematocrit [C64796]
Hemoglobin [C64848]
Lymphocytes [C51949]
Occult Blood [C74686]
Vitamin B12 [C64817]
Vitamin B9 [C74676]
pH [C45997]

Laboratory Test Code [CL.LBTESTCD, C65047]
Permitted Value (Code)	Display Value (Decode)
BILI [C38037]	Bilirubin
BUN [C61019]	Blood Urea Nitrogen
GLUC [C41376]	Glucose
HCT [C64796]	Hematocrit
HGB [C64848]	Hemoglobin
LYM [C51949]	Lymphocytes
OCCBLD [C74686]	Occult Blood
PH [C45997]	pH
VITB12 [C64817]	Vitamin B12
VITB9 [C74676]	Vitamin B9

Marital Status [CL.MARISTAT, C76348]
Permitted Value (Code)
DIVORCED [C51776]
DOMESTIC PARTNER [C53262]
LEGALLY SEPARATED [C51777]
MARRIED [C51773]
NEVER MARRIED [C51774]
WIDOWED [C51775]

Method [CL.METHOD, C85492]
Permitted Value (Code)
DIPSTICK [*]
QUANT [*]

* Extended Value

Domain Abbreviation (MH) [CL.MH.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
MH [C49603]	Medical History

Body System or Organ Class [CL.MHBODSYS]
Permitted Value (Code)
Endocrine-Metabolic
Eyes-Ears-Nose-Throat
Genitourinary
Musculoskeletal
Neurological

Category for Medical History [CL.MHCAT]
Permitted Value (Code)
MEDICAL AND SURGICAL HISTORY
PSYCHIATRIC HISTORY

Relation to Reference Period (MHENRF) [CL.MHENRF, C66728]
Permitted Value (Code)
BEFORE [C25629]
DURING/AFTER [C49640]

Interpretation: Original Results [CL.NABCLIN]
Permitted Value (Code)
ABNORMAL
NORMAL

Completion/Reason for Non-Completion [CL.NCOMPLT, C66727]
Permitted Value (Code)
ADVERSE EVENT [C41331]
COMPLETED [C25250]
INFORMED CONSENT [*]
LACK OF EFFICACY [C48226]
LOST TO FOLLOW-UP [C48227]
PHYSICIAN DECISION [C48250]
PROTOCOL VIOLATION [C48251]
RANDOMIZED [*]
SCREEN FAILURE [C49628]
WITHDRAWAL BY SUBJECT [C49634]

* Extended Value

Reference Range Indicator [CL.NRIND, C78736]
Permitted Value (Code)
ABNORMAL [C78802]
HIGH [C78800]
LOW [C78801]
NORMAL [C78727]

No Yes Response Subset [CL.NY, C66742]
Permitted Value (Code)	Display Value (Decode)
Y [C49488]	Yes
N [C49487]	No
U [C17998]	Unknown

No Yes Response [CL.NYNA, C66742]
Permitted Value (Code)	Display Value (Decode)
Y [C49488]	Yes
N [C49487]	No
NA [C48660]	Not Applicable

Domain Abbreviation (PE) [CL.PE.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
PE [C49608]	Physical Exam

PE Tests [CL.PETEST]
Permitted Value (Code)
Abdomen
Appearance/Skin
Cardiovascular
Eyes-Ears-Nose-Throat
Head/Neck (Including Thyroid)
Musculoskeletal
Neurological
Pulmonary
Other

PE Test Codes [CL.PETESTCD]
Permitted Value (Code)	Display Value (Decode)
PE01	Appearance/Skin
PE02	Head/Neck (Including Thyroid)
PE03	Eyes-Ears-Nose-Throat
PE04	Cardiovascular
PE05	Pulmonary
PE06	Abdomen
PE07	Neurological
PE08	Musculoskeletal
PE09	Other

PSRESPF [CL.PSRESPF]
Permitted Value (Code)
GOOD
NO CHANGE
POOR

Domain Abbreviation (QS) [CL.QS.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
QS [C49609]	Questionnaires

QS Tests [CL.QSTEST]
Permitted Value (Code)
Agitation
Anxiety
Appetite Loss
Attention and Calculation
Difficulty Falling Asleep
Diurnal Variation of Mood
Early Morning Awakening
Global Improvement
Irritability
Lack of Energy
Lack of Reactivity to Pleasant Events
Language
Loss of Interest
Mood-Congruent Delusions
Multiple Awakenings During Sleep
Multiple Physical Complaints
Orientation place score
Orientation time score
Pessimism
Poor Self-Esteem
Recall
Registration
Retardation
Sadness
Suicide
Total Score
Weight Loss

QS Test Codes [CL.QSTESTCD]
Permitted Value (Code)	Display Value (Decode)
CGIGLOB	Global Improvement
CSDD01	Anxiety
CSDD02	Sadness
CSDD03	Lack of Reactivity to Pleasant Events
CSDD04	Irritability
CSDD05	Agitation
CSDD06	Retardation
CSDD07	Multiple Physical Complaints
CSDD08	Loss of Interest
CSDD09	Appetite Loss
CSDD10	Weight Loss
CSDD11	Lack of Energy
CSDD12	Diurnal Variation of Mood
CSDD13	Difficulty Falling Asleep
CSDD14	Multiple Awakenings During Sleep
CSDD15	Early Morning Awakening
CSDD16	Suicide
CSDD17	Poor Self-Esteem
CSDD18	Pessimism
CSDD19	Mood-Congruent Delusions
CSDDTOT	Total Score
MMSEA1	Orientation time score
MMSEA2	Orientation place score
MMSEB	Registration
MMSEC	Attention and Calculation
MMSED	Recall
MMSEET	Language
MMSETOT	Total Score

Race [CL.RACE, C74457]
Permitted Value (Code)
WHITE [C41261]
AMERICAN INDIAN OR ALASKA NATIVE [C41259]
BLACK OR AFRICAN AMERICAN [C16352]
ASIAN [C41260]
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219]
OTHER [*]
MULTIPLE [*]

* Extended Value

Route of Administration [CL.ROUTE, C66729]
Permitted Value (Code)
ORAL [C38288]
SUBCUTANEOUS [C38299]
INTRAMUSCULAR [C28161]
INTRAVENOUS [C38276]
RECTAL [C38295]
TOPICAL [C38304]
NASAL [C38284]
INTRASINAL [C38262]
OTHER [C38290]

Domain Abbreviation (SC) [CL.SC.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
SC [C49610]	Subject Characteristics

SC Tests [CL.SCTEST, C103330]
Permitted Value (Code)
Education Level [C17953]
Marital Status [C25188]
Subject Initials [*]

* Extended Value

Subject Characteristic Code (SCTESTCD) [CL.SCTESTCD, C74559]
Permitted Value (Code)	Display Value (Decode)
EDLEVEL [C17953]	Education Level
MARISTAT [C25188]	Marital Status
SUBJINIT [*]	Subject Initials

* Extended Value

Domain Abbreviation (SE) [CL.SE.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
SE [C49616]	Subject Element

Sex [CL.SEX, C66731]
Permitted Value (Code)	Display Value (Decode)
F [C16576]	Female
M [C20197]	Male
U [C17998]	Unknown

Size [CL.SIZE, C66733]
Permitted Value (Code)
SMALL [C25376]
MEDIUM [C49507]
LARGE [C49508]

Specimen Type [CL.SPECTYPE, C78734]
Permitted Value (Code)
BLOOD [C12434]
SERUM [C13325]
URINE [C13283]

Domain Abbreviation (SV) [CL.SV.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
SV [C49617]	Subject Visits

Domain Abbreviation (TA) [CL.TA.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
TA [C49618]	Trial Arms

Domain Abbreviation (TE) [CL.TE.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
TE [C49619]	Trial Elements

Domain Abbreviation (TI) [CL.TI.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
TI [C49620]	Trial Inclusion/Exclusion Criteria

Reported Term for the Disposition Record [CL.TREASFF]
Permitted Value (Code)
COMPLETED
DID NOT MEET INCLUSION CRITERIA #3
DISCONTINUED DUE TO ADVERSE EVENT
DISCONTINUED DUE TO CONSENT WITHDRAWEL
DISCONTINUED DUE TO LACK OF THERAPEUTIC RESPONSE
DISCONTINUED DUE TO LOST TO FOLLOW UP
DISCONTINUED DUE TO SPONSOR/INVESTIGATOR DECISION
INFORMED CONSENT OBTAINED
PATIENT DID NOT MEET INCLUSION/EXCLUSION CRITERIA AT SCREENING
PROTOCOL VIOLATION
RANDOMIZED

Domain Abbreviation (TS) [CL.TS.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
TS [C53483]	Trial Summary

Trial Summary Parameter Test Name [CL.TSPARM, C67152]
Permitted Value (Code)
Added on to Existing Treatments [C49703]
Age Span [C20587]
Age Unit [*]
Clinical Study Sponsor [C70793]
Control Type [C49647]
Dose Units [C73558]
Dose per Administration [C25488]
Dosing Frequency [C89081]
Investigational Therapy or Treatment [C41161]
Planned Maximum Age of Subjects [C49694]
Planned Minimum Age of Subjects [C49693]
Planned Number of Subjects [C49692]
Route of Administration [C38114]
Sex of Participants [C49696]
Trial Blinding Schema [C49658]
Trial Indication Type [C49652]
Trial Length [C49697]
Trial Phase Classification [C48281]
Trial Primary Objective [C85826]
Trial Secondary Objective [C85827]
Trial Title [C49802]
Trial Type [C49660]
Trial is Randomized [C25196]

* Extended Value

Trial Summary Parameter Test Code [CL.TSPARMCD, C66738]
Permitted Value (Code)	Display Value (Decode)
ADDON [C49703]	Added on to Existing Treatments
AGEMAX [C49694]	Planned Maximum Age of Subjects
AGEMIN [C49693]	Planned Minimum Age of Subjects
AGESPAN [C20587]	Age Span
AGEU [*]	Age Unit
DOSE [C25488]	Dose per Administration
DOSFRQ [C89081]	Dosing Frequency
DOSU [C73558]	Dose Units
LENGTH [C49697]	Trial Length
OBJPRIM [C85826]	Trial Primary Objective
OBJSEC [C85827]	Trial Secondary Objective
PLANSUB [C49692]	Planned Number of Subjects
RANDOM [C25196]	Trial is Randomized
ROUTE [C38114]	Route of Administration
SEXPOP [C49696]	Sex of Participants
SPONSOR [C70793]	Clinical Study Sponsor
TBLIND [C49658]	Trial Blinding Schema
TCNTRL [C49647]	Control Type
TINDTP [C49652]	Trial Indication Type
TITLE [C49802]	Trial Title
TPHASE [C48281]	Trial Phase Classification
TRT [C41161]	Investigational Therapy or Treatment
TTYPE [C49660]	Trial Type

* Extended Value

Domain Abbreviation (TV) [CL.TV.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
TV [C49621]	Trial Visits

Unit (UH_MC) [CL.UH_MC, C71620]
Permitted Value (Code)	Display Value (Decode)
cm [C49668]	Centimeter

Unit (UH_NMC) [CL.UH_NMC, C71620]
Permitted Value (Code)	Display Value (Decode)
IN [C48500]	Inch

Unit (UW_MC) [CL.UW_MC, C71620]
Permitted Value (Code)	Display Value (Decode)
kg [C28252]	Kilogram

Unit (UW_NMC) [CL.UW_NMC, C71620]
Permitted Value (Code)	Display Value (Decode)
LB [C48531]	Pound

Domain Abbreviation (VS) [CL.VS.DOMAIN, C66734]
Permitted Value (Code)	Display Value (Decode)
VS [C49622]	Vital Signs

Units for Vital Signs Results [CL.VSRESU, C66770]
Permitted Value (Code)	Display Value (Decode)
BEATS/MIN [C49673]	Beats per Minute
cm [C49668]	Centimeter
kg [C28252]	Kilogram
mmHg [C49670]	Millimeter of Mercury

Vital Signs Test Name [CL.VSTEST, C67153]
Permitted Value (Code)
Body Frame Size [C49680]
Diastolic Blood Pressure [C25299]
Height [C25347]
Pulse Rate [C49676]
Systolic Blood Pressure [C25298]
Weight [C25208]

Vital Signs Test Code [CL.VSTESTCD, C66741]
Permitted Value (Code)	Display Value (Decode)
DIABP [C25299]	Diastolic Blood Pressure
FRMSIZE [C49680]	Body Frame Size
HEIGHT [C25347]	Height
PULSE [C49676]	Pulse Rate
SYSBP [C25298]	Systolic Blood Pressure
WEIGHT [C25208]	Weight

Go to the top of the define.xml

External Dictionaries
Reference Name	External Dictionary	Dictionary Version
Adverse Event Dictionary (CL.AEDICT_F)	MEDDRA	8.0
Drug Dictionary (CL.DRUGDICT_F)	WHODRUG	200204
ISO3166 (CL.ISO3166)	ISO3166

Computational Algorithms

Computational Algorithms
Method	Type	Description
Algorithm to derive AEENDY	Computation	AEENDY = AEENDTC -RFSTDTC+1 if AEENDTC is on or after RFSTDTC. AEENDTC - RFSTDTC if AEENDTC precedes RFSTDTC
Algorithm to derive AESTDY	Computation	AESTDY = AESTDTC - RFSTDTC+1 if AESTDTC is on or after RFSTDTC. AESTDTC - RFSTDTC if AESTDTC precedes RFSTDTC
Algorithm to derive the AETRTEM flag	Computation	AETRTEM = "Y" if Adverse Event was not present prior to the RFSTDTC, or it was present prior to the RFSTDTC but increased in severity during the treatment period. Null otherwise.
Algorithm to derive AGE	Computation	Age at Screening Date (Screening Date - Birth date). For the complete algorithm see the referenced external document. Complex Algorithms (complexalgorithms.pdf)
Algorithm to derive CLSIG	Computation	Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan.
Algorithm to derive CMENDY	Computation	CMENDY = CMENDTC - RFSTDTC +1 if CMENDTC is on or after RFSTDTC. CMENDTC - RFSTDTC if CMENDTC precedes RFSTDTC
Algorithm to derive CMSTDY	Computation	CMSTDY = CMSTDTC - RFSTDTC +1 if CMSTDTC is on or after RFSTDTC. CMSTDTC - RFSTDTC if CMSTDTC precedes RFSTDTC
Algorithm to derive DA.VISITNUM	Computation	Derived from DADTC and SVSTDTC.
Algorithm to derive DADY	Computation	DADY = DADTC - RFSTDTC+1 if DADTC is on or after RFSTDTC. DADTC - RFSTDTC if DADTC precedes RFSTDTC.
Algorithm to derive DASTRESC	Computation	DASTRESC = DAORRES
Algorithm to derive DASTRESN	Computation	DASTRESN = numeric value of DAORRES, when DAORRES contains numeric data.
Algorithm to derive DASTRESU	Computation	DASTRESU = DAORRESU
Algorithm to derive DSSTDY	Computation	DSSTDY = DSSTDTC - RFSTDTC+1 if DSSTDTC is on or after RFSTDTC. DSSTDTC - RFSTDTC if DSSTDTC precedes RFSTDTC. Null if RFSTDTC is Null.
Algorithm to derive EGBLFL	Computation	Safety subjects only: EGBLFL = "Y" for last record with non Null EGORRES on or before the first dose date (RFSTDTC). Null otherwise
Algorithm to derive EGDRVFL	Computation	EGDRVFL = "Y" for derived EGTESTCDs QTCB and QTCF. Null otherwise. Complex Algorithms (complexalgorithms.pdf)
Algorithm to derive EGDY	Computation	EGDY = EGDTC-RFSTDTC+1 if EGDTC is on or after RFTSDTC. EGDTC - RFSTDTC if EGDTC precedes RFSTDTC.
Algorithm to derive EGSTRESC	Computation	Data collected in non-standard units is converted using standard conversion factors to standard units.
Algorithm to derive EGSTRESN	Computation	EGSTRESN = numeric value of EGSTRESC, when EGSTRESC contains numeric data.
Algorithm to derive EXDOSE	Computation	If ARMCD=WONDER10 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 10. If ARMCD=WONDER20 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 20. If ARMCD=PLACEBO then EXDOSE = 0.
Algorithm to derive EXDOSU	Computation	Derived from ARM, ARMCD - equal to mg
Algorithm to derive EXENDY	Computation	EXENDY = EXENDTC-RFSTDTC+1 if EXENDTC is on or after RFSTDTC. EXENDTC - RFSTDTC if EXENDTC precedes RFSTDTC.
Algorithm to derive EXSTDY	Computation	EXSTDY = EXSTDTC - RFSTDTC+1 if EXSTDTC is on or after RFSTDTC. EXSTDTC - RFSTDTC if EXSTDTC precedes RFSTDTC.
Algorithm to derive EXTRT	Computation	Derived from ARM, ARMCD
Algorithm to derive IESTRESC	Computation	IESTRESC = IEORRES
Algorithm to derive LBBLFL	Computation	Safety subjects only: LBBLFL = "Y" for last record with non Null LBORRES on or before the first dose date (RFSTDTC). Null otherwise.
Algorithm to derive LBDY	Computation	LBDY = LBDTC-RFSTDTC+1 if LBDTC is on or after RFSTDTC. LBDTC - RFSTDTC if LBDTC precedes RFSTDTC.
Algorithm to derive LBNRIND	Computation	Reference Range Indicator based upon standard results and ranges.
Algorithm to derive PEDY	Computation	PEDY = PEDTC-RFSTDTC+1 if PEDTC is on or after RFSTDTC. PEDTC - RFSTDTC if PEDTC precedes RFSTDTC.
Algorithm to derive PESTRESC	Computation	PESTRESC = PEORRES
Algorithm to derive QSBLFL	Computation	Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise.
Algorithm to derive QSDY	Computation	QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC.
Algorithm to derive QSSTRESC	Computation	If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data.
Algorithm to derive QSSTRESN	Computation	When QSORRES is numeric then QSSTRESN equal to numeric result
Algorithm to derive QTCB	Computation	QTcB = QT interval / square root of (60 / heart rate). For the complete algorithm see the referenced external document. Complex Algorithms (complexalgorithms.pdf)
Algorithm to derive QTCF	Computation	QTcF = QT interval / cubic root of (60 / heart rate). For the complete algorithm see the referenced external document. Complex Algorithms (complexalgorithms.pdf)
Algorithm to derive RDOMAIN	Computation	Domain abbreviation from where data originated.
Algorithm to derive RELID	Computation	All records for the same USUBJID with the same RELID are considered related.
Algorithm to derive RFENDTC	Computation	RFENDTC = termination date, for safety subjects. Null for screen failures.
Algorithm to derive RFSTDTC	Computation	RFSTDTC = first date/time of study drug, for safety subject. Null for screen failures.
Algorithm to derive the SAFETY population flag	Computation	SAFETY = "Y" for randomized subjects who took at least one dose study medication. Null otherwise.
Algorithm to derive SCDY	Computation	SCDY = SCDTC-RFSTDTC+1 if SCDTC is on or after RFSTDTC. SCDTC - RFSTDTC if SCDTC precedes RFSTDTC.
Algorithm to derive SCSTRESC	Computation	SCSTRESC = SCORRES
Algorithm to derive SEENDTC	Computation	If Element = SCREEN, derived from SVENDTC where VISIT = SCREENING. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT or from the latest EXENDTC from EX whichever is later. For treatment Elements, derived from last EXENDTC for the element. For the complete algorithm see the referenced external document. Complex Algorithms (complexalgorithms.pdf)
Algorithm to derive SEQ	Computation	Sequential number identifying records within each USUBJID in the domain.
Algorithm to derive SESTDTC	Computation	If Element = SCREEN, derived from SVSTDTC where VISIT = SCREENING or from DS where DSDECOD = 'INFORMED CONSENT', whichever is earliest. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT. For treatment Elements, derived from first EXSTDTC for the element. For the complete algorithm see the referenced external document. Complex Algorithms (complexalgorithms.pdf)
Algorithm to derive SV.VISIT	Computation	Derived from visit-based subject-level domains
Algorithm to derive VISITNUM	Computation	Derived from visit-based subject-level domains
Algorithm to derive SVENDTC	Computation	SVENDTC = SVSTDTC
Algorithm to derive SVSTDTC	Computation	Derived from visit-based subject-level domains
Algorithm to derive SVSTDY	Computation	SVSTDY = SVSTDTC-RFSTDTC+1 if SVSTDTC is on or after RFSTDTC. SVSTDTC - RFSTDTC if SVSTDTC precedes RFSTDTC.
Algorithm to derive TSSEQ	Computation	Sequential number identifying records within each TSPARM in the domain.
Algorithm to derive USUBJID	Computation	Concatenation of STUDYID and SUBJID catx(".",STUDYID,SUBJID)
Algorithm to derive VSBLFL	Computation	Safety subjects only: VSBLFL = "Y" for last record with non Null VSORRES on or before the first dose date (RFSTDTC). Null otherwise.
Algorithm to derive VSDY	Computation	VSDY = VSDTC-RFSTDTC+1 if VSDTC is on or after RFSTDTC. VSDTC - RFSTDTC if VSDTC precedes RFSTDTC.
Algorithm to derive VSSTRESC	Computation	Data collected in non-standard units (i.e. lbs, inches) is converted using standard conversion factors to standard units (kg, cm).
Algorithm to derive VSSTRESN	Computation	VSSTRESN = numeric value of VSSTRESC, when VSSTRESC contains numeric data.

Comments

Comments
CommentOID	Description
COM.LBREFID	Accession number
COM.RELTYPE	All values are null since this is used only when identifying a dataset-level relationship.
COM.ARMCD	Assigned based on Randomization Number. See Note 2.1 Reviewers Guide (reviewersguide.pdf)
COM.MHBODSYS	Assigned for Medical History but not Psychiatric History
COM.ARM	Assigned from TA.ARM based on ARMCD.
COM.EG.VISITNUM	Assigned from the TV domain based on the VISIT
COM.IE.VISITNUM	Assigned from the TV domain based on the VISIT
COM.PE.VISITNUM	Assigned from the TV domain based on the VISIT
COM.QS.VISITNUM	Assigned from the TV domain based on the VISIT
COM.VS.VISITNUM	Assigned from the TV domain based on the VISIT
COM.CMCLASCD	Coded to ATC level 3 Code based on CMINDC
COM.CMCLAS	Coded to ATC level 3 Term based on CMINDC
COM.DSDECOD	CRF controlled terminology was mapped to match CDISC controlled terminology.
COM.MHENRF	CRF controlled terminology was mapped to match CDISC controlled terminology.
COM.AGEU	Defaulted to YEARS
COM.EGSPID	ECG parameter ordering variable
COM.EGEVAL	Equal to INVESTIGATOR for CRF data
COM.EGPOS	Equal to SUPINE
COM.CMROUTE	Free text from CRF mapped to CDISC CT
COM.SUBJECTDATA-JOIN-DM	Join any Subject Level dataset with the Demographics dataset based on [IG.datasetname]IT.USUBJID = [IG.DM]IT.USUBJID, assuming 'IG.datasetname' is the OID of the ItemGroupDef that defines the subject-level dataset to be joined with the Demographics dataset.
COM.IDVAR	Name of the variables for the related records.
COM.DOMAIN.QS	QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section. Reviewers Guide (reviewersguide.pdf)
COM.SUPPQS.QVAL.RTRINIT	QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17
COM.DOMAIN.DM	See Reviewer's Guide, Section 2.1 Demographics Reviewers Guide (reviewersguide.pdf)
COM.VSSTRESU	Standard units consistent with CDISC controlled terminology
COM.STUDY.DATA	The data submitted only includes subjects in the USA since other sites did not enroll any subjects.
COM.IDVARVAL	Value of identifying variable described in IDVAR.

Tabulation Data Definition Tables

Value Level Metadata

Controlled Terms

External Dictionaries

Computational Algorithms

Comments