studyid usubjid aedtc visitnum epoch aestdtc aeterm … · domain: qs. usubjid. studyid. epoch....

DOMAIN: AE

USUBJID

STUDYID

EPOCH

VISITNUM

AEDTC

AESPID

AESTDTC

THIS DATA NOT ENTEREDAETERM

AEREL

AESEV

AEOUT

AEACN

AESER

THIS DATA NOT ENTERED

AEENDTC

AEACNOTH

AEENRF


DOMAIN: QS

USUBJID

STUDYID

EPOCH

VISITNUM

QSDTC

QSEVAL

QSCAT=ADJECTIVE RATING SCALE FOR WITHDRAWAL

QSEVLINT=-PT24H

QSTEST

QSORRES


DOMAIN: QS

USUBJID

STUDYID

EPOCH

VISITNUM

QSDTC

QSEVAL

QSCAT=ADDICTION SEVERITY INDEX LITE

QSTEST QSORRES

QSSCAT=



USUBJID

QSTEST QSORRES


QSDTC

QSORRESU=‘YEAR’ QSORRESU=‘MONTH’

QSEVLNT=-P30D

QSEVLNT=-P30DQSORRESU=‘DAY’

DOMAIN: QS


USUBJID

QSTEST QSORRES


QSDTC

QSORRESU=‘DAY’

QSEVLNT=-P30D

QSEVLNT=-P30D

QSSCAT= DOMAIN: QS


USUBJID

QSTEST QSORRES


QSDTC

QSORRESU=‘DAY’QSEVLNT=-P30D

QSORRESU=‘YEAR’QSORRESU=‘MONTH’

QSORRESU=‘MONTH’

QSORRESU=‘YEAR’


QSEVLINT=-P3Y

QSSCAT= DOMAIN: QS


USUBJID

QSTEST QSORRES


QSDTC

QSORRESU=‘DOLLAR’

QSEVLNT=-P30D

QSORRESU=‘DAY’

QSEVLNT=-P30D

QSEVLNT=-P30D

QSEVLNT=-P30D

DOMAIN: QS


USUBJID

QSTEST

QSORRES THIS DATA NOT ENTERED

QSDTC

QSORRESU=‘DAY’

QSEVLNT=-P30D

QSORRESU=‘YEAR’

QSSCAT= DOMAIN: QS


USUBJID

QSTEST QSORRES


QSDTC

QSORRESU=‘DOLLAR’QSEVLNT=-P30D

QSORRESU=‘DOLLAR’QSEVLNT=-P30D

QSEVLNT=-P30D QSORRESU=‘DAY’


QSEVLNT=-P30D


QSEVLNT=-P30D

DOMAIN: QS


QSSCAT=

USUBJID

QSTEST QSORRES


QSDTC

DOMAIN: QS


USUBJID

QSTEST QSORRES


QSDTC


DOMAIN: QS


USUBJID

QSTEST QSORRES


QSDTC

QSORRESU=‘DAY’

QSEVLINT=-P30D

QSORRESU=‘DAY’

QSEVLINT=-P30D

DOMAIN: QS


QSSCAT=

USUBJID

QSTEST QSORRES


QSDTC

QSEVLINT=-P3Y

DOMAIN: QS


USUBJID

QSTEST

QSORRES


QSDTC

QSEVLINT=-P30D

DOMAIN: QS


USUBJID

QSTEST QSORRES


QSDTC

QSEVLINT=-P30D

QSEVLINT=-P30D

QSORRESU=‘DAY’

QSEVLINT=-P30D

DOMAIN: QS


USUBJID

QSTEST QSORRES


QSDTC

QSEVLINT=-P30D

QSSCAT= DOMAIN: QS


USUBJID

QSTEST QSORRES THIS DATA NOT ENTERED

QSDTC

QSEVLINT=-P30D

QSORRESU=‘DAY’

QSEVLINT=-P30D

DOMAIN: QS



DOMAIN: QS


DOMAIN: EX

USUBJID

STUDYID

EPOCH

VISITNUM

EXDTC

EXSTDTCEXDOSE

EXDOSU

QNAM=EXFINALQLABEL=IS PATIENT FINAL DOSE RECORDEDIDVAR=VISITNUM

DOMAIN: COCOVALRDOMAIN=EXIDVAR=VISITNUM

EXDOSFRQ

QNAM=EXLOCALEQLABEL=LOCATION DOSEDIDVAR=VISITNUM

EXCAT=DOSE LOG





DOMAIN: CM

USUBJID

STUDYID

EPOCH

VISITNUM CMDTC

CMSPID

CMTRT

CMINDC

CMDOSE

CMDOSU

CMDOSFRQ

CMSTDTC

CMENDTC

CMSTRF


CMGRPID

CMCAT=CONCOMITANT

DOMAIN: QS, VS

USUBJID

STUDYID

EPOCH

VISITNUM QSDTC/VSDTC

QSEVAL

QSTESTQSORRES

VS.VSTEST=PUL SE RATE

VS.VSORRES

VS.VSORRESU

QSEVLINT=-PT30M

QSEVLINT=-PT30M


QSTEST QSORRES

DOMAIN: QS


DOMAIN: VS, RP, SU, CO

USUBJID

STUDYID

EPOCH VISITNUM

VSDTC/RPDTC/SUDTC

QSEVAL


VS

VSTEST VSORRES VSORRESU

DOMAIN: COCOVALRDOMAIN=VSIDVAR=VISITNUM

RP DOMAIN: COCOVALRDOMAIN=RPIDVAR=VISITNUM

RPTEST RPORRES

SUCAT=CLINIC VISIT DRUG USE

SUTRT

SU

SUSCAT=SELF REPORT SUSCAT=TOXICOLOGY RESULTS


DOMAIN: DA, EX, CO, QS

USUBJID

STUDYID

EXDTC/CODTC/QSDTC

EX.EXTRT

DA

QS

EX.DOSE EX.DOSU

DATEST

DAORRES

EX.EXCAT=CLINIC VISIT FORM

DATESTDAORRES

DASPIDDADTC

DATEST/DAORRES DATEST/DAORRES

QSCAT=PSYCHOSOCIAL COUNSELING

QSTEST QSORRES

DOMAIN: COCOVALRDOMAIN=DAIDVAR=DASPID

DOMAIN: COCOVALRDOMAIN=QSIDVAR=QSSEQ

THIS DATA NOT ENTEREDTHIS DATA NOT ENTERED

DOMAIN: DM, SC

USUBJID

STUDYID

EPOCH

VISITNUM DMDTC/SCDTC

DM.SEX

DM.BRTHDTC

DM.RACE (if multiple, then ‘MULTIPLE’)

SCTEST

SCORRESQNAM=SOTHERSQLABEL=SPANISH, HISPANIC, OR LATINO: OTHER TEXTIDVAR=SCSEQ

QNAM=AOTHERSQLABEL=ASIAN: OTHER TEXTIDVAR=SCSEQ

QNAM=NOTHERSQLABEL=NATIVE HAWAIIAN OR PACIFIC ISLANDER: OTHER TEXTIDVAR=SCSEQ

QNAM=OOTHERSQLABEL=ESTHNICITY/RACE: OTHER TEXTIDVAR=SCSEQ

SCTEST

SCORRES

SCTEST

SCORRES

SCTEST

SCORRES

SCTEST SCORRES

SCORRESU


DOMAIN: SU

USUBJID

SUDTC

SUCAT=DRUG/ALCOHOL USE

SUCAT=MAJOR DRUG PROBLEM

SUTRT

SUTRT

SUROUTE

SUDURSUEVLINT=-P30D



DOMAIN: QS

USUBJID

STUDYID

EPOCH

VISITNUM

QSDTC

QSEVAL

QSCAT=DSM-IV: SUBSTANCE RELATED DISORDERS

QSTEST

QSEVLINT=-P12M

QSORRES


QSTEST

QSEVLINT=-P12M

QSORRES

DOMAIN: QS


DOMAIN: QS


QSTEST QSORRES

USUBJID QSDTC



DOMAIN: IE

USUBJID

STUDYID

EPOCH VISITNUM

IEDTC

NOTE: Only exceptions to IE are in the database. That includes “No” responses for inclusion and “yes” responses for exclusion criteria.

IECAT

IECAT

IEORRES

IETEST


DOMAIN: DM, SC, DS

USUBJID

STUDYID

EPOCH

VISITNUM

DMDTC/SCDTC/DSDTC

SC.SCTEST SC.SCORRES

DS.DSTERM DS.DSOCCUR

DM.RFSTDTC

DS.DSTERM DS.DSSTDTC

DS.DSTERM DS.DSOCCUR

QNAM=DSOTHERQLABEL=NOT INDUCTED OTHER SPECIFYIDVAR=VISITNUM


DOMAIN: LB, CO

USUBJID

STUDYID

EPOCH

VISITNUM

LBDTC

DOMAIN: COCOVALRDOMAIN=LBIDVAR=VISITNUM

QNAM=LBMONITQLABEL=ADDITIONAL MONITORING REQUIREDIDVAR=LBDTC


LBCAT=HEPATITIS SEROLOGY

LBCAT=LIVER FUNCTION

LBTEST

LBORRES

LBORRESU


LBTEST LBTEST LBTEST

LBORRES

LBORRES

LBORRES

DOMAIN: MH

USUBJID

STUDYID

EPOCH

VISITNUM

MHDTC

MHTERM MHOCCUR MHOCCUR

MHENRF=BEFORE MHENRF=DURING/AFTER

DOMAIN: COCOVALRDOMAIN=MHIDVAR=VISITNUM

THIS DATA NOT ENTEREDTHIS DATA NOT ENTERED

MHSPID

DOMAIN: PE, VS

USUBJID

STUDYID

EPOCH

VISITNUM

PEDTC/VSDTC

VS.VSTEST VSORRES VSORRESU

VS.VSTEST VSORRES VSORRESU

DOMAIN: COCOVALRDOMAIN=PEIDVAR=PESPID

PETEST

PEORRES

PESPID

If ‘Not assessed’ then PESTAT=NOT DONE and PEREASND=NA




THIS DATA NOT RETAINED

DOMAIN: CM

USUBJID

STUDYID

EPOCH

VISITNUM

CMDTC

CMSPID

CMTRT CMINDC

CMDOSE CMDOSUCMDOSFRQ

CMSTDTC CMENDTC CMSTRF


CMCAT=PRIOR

DOMAIN: SC, DM

USUBJID

STUDYID

VISITNUM

DMDTC/SCDTC




DM.ARM


DOMAIN: QS

USUBJID

STUDYID

EPOCH

VISITNUM

QSDTC

QSTEST

QSORRES

QSCAT=RISK BEHAVIORS SURVEY

QSSCAT=DRUG USE

QSORRESU=DAY QSORRESU=DAY

QSEVLINT=-P30D

QSEVAL


DOMAIN: QS

USUBJID QSDTC

QSTEST

QSCAT=RISK BEHAVIOR SURVEY

QSEVLINT=-P30D

QSSCAT=DRUG INJECTION

QSSCAT=SEXUAL ACTIVITY

QSORRES


DOMAIN: QS

USUBJID QSDTC

QSTEST


QSEVLINT=-P30D

QSORRES

QSSCAT=SEXUAL ACTIVITY – CLIENT WITH FEMALE PARTNER


DOMAIN: QS

USUBJID QSDTC

QSTEST


QSEVLINT=-P30D

QSORRES

QSSCAT=SEXUAL ACTIVITY – MALE CLIENT WITH FEMALE PARTNER

QSSCAT=SEXUAL ACTIVITY – MALE CLIENT WITH MALE PARTNER


DOMAIN: QS

USUBJID QSDTC

QSTEST


QSEVLINT=-P30D

QSORRES

QSSCAT=SEXUAL ACTIVITY – CLIENT WITH MALE PARTNER


DOMAIN: QS

USUBJID QSDTC

QSTEST


QSEVLINT=-P30D

QSORRES

QSSCAT=SEXUAL ACTIVITY – FEMALE CLIENT WITH MALE PARTNER

QSSCAT=SEXUAL ACTIVITY – CLIENT WITH MALE PARTNER


DOMAIN: AE

USUBJID

STUDYID

EPOCH

VISITNUM

AEDTC

QNAM=AESEXQLABEL=SEX (SAE PAGE)IDVAR=AESEQ

QNAM=AEDOBQLABEL=DATE OF BIRTH (SAE PAGE)IDVAR=AESEQ

QNAM=AEETHNICQLABEL=RACE/ETHNICITY (SAE PAGE)IDVAR=AESEQ

QNAM=AEHGTQLABEL=HEIGHT (SAE PAGE)IDVAR=AESEQ

QNAM=AEWGTQLABEL=WEIGHT (SAE PAGE)IDVAR=AESEQ

AESER=Y

AETERM

AESTDTC

AESEV

AEREL


QNAM=AEETHOTHQLABEL=RACE/ETHNICITY OTHER, SPECIFYIDVAR=AESEQ

DOMAIN: AE

USUBJID

AEACN

AEDTC

AEACNOTH

AEOUT AESDEATH

AESLIFE

AESHOSP

AESDISAB

AESCONG

AESMIE

QNAM=AESOUTOTQLABEL=OUTCOME – OTHER, SPECIFYIDVAR=AESEQ

QNAM=RELTEST1-RELTEST3QLABEL=SAE – RELEVANT TESTS/LAB DATA, LINE 1 (2,3)IDVAR=AESEQ

QNAM=RELHIST1-RELHIST3QLABEL=RELEVANT HISTORY, PRE-EXIST COND, LINE 1 (2,3)IDVAR=AESEQ

AEENDTC

If continuing then AEENRF=DURING/AFTER


DOMAIN: AE

USUBJID AEDTC

QNAM=IANAMEQLABEL=INV AGENT NAMEIDVAR=AESEQ

QNAM=IANAMEQLABEL=INV AGENT LOT NUMBERIDVAR=AESEQ

QNAM=IAEXPDTQLABEL=INV AGENT EXPIRATION DATEIDVAR=AESEQ

QNAM=IAROUTEQLABEL=INV AGENT ROUTEIDVAR=AESEQ

QNAM=IAROTHQLABEL=INV AGENT ROUTE – OTHER, SPECIFYIDVAR=AESEQ

QNAM=IAFRQOTHQLABEL=INV AGENT FREQUENCY – OTHER, SPECIFYIDVAR=AESEQ

QNAM=IAFREQQLABEL=INV AGENT FREQUENCYIDVAR=AESEQ

QNAM=IAQUANTQLABEL=INV AGENT QUANTITYIDVAR=AESEQ

QNAM=IAUNITQLABEL=INV AGENT UNITIDVAR=AESEQ

QNAM=IAUNTOTHQLABEL=INV AGENT UNIT – OTHER, SPECIFYIDVAR=AESEQ

QNAM=IASTDTCQLABEL=INV AGENT START DATEIDVAR=AESEQ

QNAM=IAENDTCQLABEL=INV AGENT END DATEIDVAR=AESEQ



QNAM=INVNAMEQLABEL=INVESTIGA TOR NAMEIDVAR=AESEQ

QNAM=DRNAMEQLABEL=PHYSICIAN’ S NAMEIDVAR=AESEQ

QNAM=INVSIGDTQLABEL=INV AGENT DATE INVESTIGATOR SIGNEDIDVAR=AESEQ

QNAM=DRSIGDTQLABEL=INV AGENT DATE PHYSICIAN SIGNEDIDVAR=AESEQ


DOMAIN: CO

USUBJID CODTC

COVAL1-COVAL16

IDVAR=AESEQ


DOMAIN: QS

USUBJID

STUDYID

EPOCH

VISITNUM

QSDTC

QSTESTQSORRES

QSCAT=SATISFACTION QUESTIONNAIRE

QSEVAL


QSTESTQSORRES

DOMAIN: QS

USUBJID QSDTC

DOMAIN: COCOVALRDOMAIN=QSIDVAR=VISITNUM


DOMAIN: DS, DM, SC

USUBJID

STUDYID

EPOCH

VISITNUM

DSDTC

DM.RFENDTC

DSOCCUR

DSTERM

QNAM=DSWITHDQLABEL=OTHER REASON FOR WITHDRAWALIDVAR=VISITNUM



DOMAIN: QS

USUBJID

STUDYID

EPOCH

VISITNUMQSDTC

QSTEST

QSORRES

QSCAT=VISUAL ANALOG SCALE

QSEVAL

QSORRESU=0-100 POINT ANALOG SCALE


studyid usubjid aedtc visitnum epoch aestdtc aeterm … · domain: qs. usubjid. studyid. epoch....

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