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End of Study Form

endstudy

01

Clinical Trials: End of Study Form

Download Definition as
Download Submission Template as
Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*guid
src_subject_idString20RequiredSubject ID how it's defined in lab/projectCATIEID, bid, case_id, id, randid, record_id, stepid, subject_id
interview_ageIntegerRequiredAge in months at the time of the interview/test/sampling/imaging.0 :: 1260Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.bslage, intvage
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired fieldeosdt, intvdate, subsum_doa
genderString20RequiredSex of the subjectM;FM = Male; F = Female
visitidIntegerRecommendedMetaTrial Visit IDSystem variable: unique code for each type of visit -use to merge files
visitString50RecommendedVisit nameCharacter description of each type of visitvtypdhs
truncvisIntegerRecommendedTruncated Visit NumberCreated variable: provides a numeric visit number for all visits, including unscheduled and end of phase
phase_ctString20RecommendedCurrent Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase.Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1
visdayIntegerRecommendedNumber of days from study baseline to date of visitdate
protocolString50RecommendedProtocol [Study] name
eos1IntegerRecommendedDid the patient complete the medication portion0;10=No; 1=Yes
eos1aIntegerRecommendedDay of study completionNumber of days from study baseline to date of study completioneos01a
eos1bIntegerRecommendedDay of medication withdrawalNumber of days from study baseline to date of medication withdrawaleos01b
eos2String20RecommendedPatient's final medication phase?Phase 1 or 1a; Phase 1b; Phase 2; Phase 3; Open-choiceeos02
eos3IntegerRecommendedIndicate who initiated the discontinuation1::41=Investigator; 2=Patient; 3=Subject advocate; 4=caregivereos03
eos4IntegerRecommendedPrimary reason for withdrawal1::61=Administrative reason, specify; 2=Patient refused to continue to next phase; 3=Adverse event precluding further study phase; 4=Other reason; 5=Caregiver/legal authorized representative; 6=Patient Deatheos04
eos5IntegerRecommendedInvestigator has signed end of study1; 01=yes; 0=noeos05
eos6IntegerRecommendedIs the patient proceeding to the follow up phase?0;10=No; 1=Yes
eos7IntegerRecommendedDid the patient sign the follow up Informed Consnt?0::20=No; 1=Yes; 2=unable to contactfuconsnt
eos8IntegerRecommendedDay follow up Informed Consent was signed?Number of days from study baseline to date follow up informed consent was signedconsdate
levelString10RecommendedTreatment level
weekFloatRecommendedWeek in level/study99=week 10-week 14
crcidString40RecommendedCRC ID/ROA ID
updateIntegerRecommendedUpdated form0;11=Updated
etlckIntegerRecommendedLack of efficacy0;10=Not checked; 1=Checked
eteffIntegerRecommendedUnacceptable side effects0;10=Not checked; 1=Checked
etcmatsIntegerRecommendedCommitted/ suicide attempt0;1; -90=Not checked; 1=Checked; -9 =Unknown
etmscdnIntegerRecommendedGeneralized condition req prtcl stop0;10=Not checked; 1=Checked
etdsymIntegerRecommendedSymptoms req nonprotocol treatment0;10=Not checked; 1=Checked
etfretIntegerRecommendedFailed to return to clinic0;10=Not checked; 1=Checked
etmvdIntegerRecommendedMoved from the area0;10=Not checked; 1=Checked
etnaproIntegerRecommendedNon-adherence to study proc.0;10=Not checked; 1=Checked
etnamedIntegerRecommendedNon-adherence to study medication0;10=Not checked; 1=Checked
etreburIntegerRecommendedFound research too burdensome0;10=Not checked; 1=Checked
etwcnrIntegerRecommendedPatient withdrew with no reason0;10=Not checked; 1=Checked
etpregIntegerRecommendedPatient became pregnant0;10=Not checked; 1=Checked
etnorandgenIntegerRecommendedCould not randomize due to gen. med cond.0;10=Not checked; 1=Checked
etnorandmedIntegerRecommendedCould not randomize, PT is on concomitant med0;10=Not checked; 1=Checked
duedateString30RecommendedDue date
daysconsIntegerRecommendeddays since consent
siteString100RecommendedSiteStudy Sitesite_no
certcodeIntegerRecommendedstepbd certification code
pcsfIntegerRecommendedpcos screening form completed0;1;-70=No; 1=Yes; -7=Refused
pcecIntegerRecommendedpcos eligibility completed0;1;-70=No; 1=Yes; -7=Refused
pcexmIntegerRecommendedpcos exam form completed0;1;-70=No; 1=Yes; -7=Refused
pcmhqIntegerRecommendedpcos menstrual hist completed0;1;-70=No; 1=Yes; -7=Refused
bloodsmpIntegerRecommendedblood samples collected0;1;-70=No; 1=Yes; -7=Refused
bloodsufIntegerRecommendedblood samples sufficient0;1;-70=No; 1=Yes; -7=Refused
ultsndcnIntegerRecommendedconsented to ultrasound0;1;-70=No; 1=Yes; -7=Refused
pcurfIntegerRecommendedpcos ultrasound form completed0;1;-70=No; 1=Yes; -7=Refused
pccurIntegerRecommendedpcos central ultsnd completed0;1;-70=No; 1=Yes; -7=Refused
pcosunabIntegerRecommendedpcos pt unable comp req assmts0;1;-70=No; 1=Yes; -7=Refused
pcosnoasIntegerRecommendedpcos pt not return assessments0;1;-70=No; 1=Yes; -7=Refused
pcosnoatIntegerRecommendedpcos pt did not attend eval0;1;-70=No; 1=Yes; -7=Refused
pcoshospIntegerRecommendedpatient hospitalized0;1;-70=No; 1=Yes; -7=Refused
pcosnocmIntegerRecommendedpcos assmts not compl in 6mo0;1;-70=No; 1=Yes; -7=Refused
pcosothrIntegerRecommendedpcos missed other reason0;1;-70=No; 1=Yes; -7=Refused
rinactIntegerRecommendedreason for inactivation1::91=Death; 2=Too sick/unstable; 3=Relocated; 4=Untraceable; 5=Drop out; 6=Incomplete study entry; 7=Ineligible, specify; 8=Other, specify; 9=Completed 24 month follow up
suicideIntegerRecommendedWas the death because of a suicide?0;1; 9990 = No; 1 = Yes; 999 = Legitimately Skippeddsuicide
inactconIntegerRecommendedinact days since consent
lifedx1String50RecommendedLifetime diagnosis 1
lifedxspString50RecommendedLifetime diagnosis specify
trt_grpString10RecommendedTreatment Group Assignment1;1AO;1CT;2;31=Group 1 first 8 weeks; 1AO=Group 1 8 week add on; 1CT=Group 1 8 week cross taper; 2=Group 2; 3=Group 3
days_baselineIntegerRecommendedDays since baselinebsldays
etypeString10RecommendedRating PeriodBSL;WK1;WK2;WK3;WK4;WK5;WK6;WK7;WK8;WK9;WK10;WK11;WK12;WK13;WK14;WK15;WK16BSL=Baseline; WK1-WK16=Weeks 1-16
respond_detail_oth_specString255RecommendedRespondent detailsinformnt
relationshipIntegerRecommendedRelationship of respondent to individual
1::84; -999
1 = Biological mom; 2 = Biological dad; 3 = Grandparent; 4 = Special education (sped) teacher; 5 = General education teacher; 6 = Occupational therapist; 7 = Speech and language therapist; 8 = Behavioral therapist; 9 = Paraprofessional; 10 = Aide; 11 = Principal; 12 = Administrator; 13 = Other; 14 = Content teacher; 15 = Parent center director; 16 = Self; 17=Adoptive mother; 18=Adoptive father; 19=Foster mother; 20 = Foster father; 21=Grandmother; 22=Grandfather; 23=Step-mother; 24 = Step-father; 25=Aunt; 26=Uncle; 27=Missing Data; 28=Both parents;31= Grandmother from mother side; 32= Grandfather from mother side; 33= Grandmother from father side; 34= Grandfather from father side; 36= Brother; 37= Sister; 38= Cousin; 39= female caregiver; 40=male caregiver; 41=Female child; 42=Male child; 43=Spouse/Mate; 44=Friend; 45=Parent; 46=Significant other; 47=Sibling; 48=Son/Daughter; 49=Son-in-law/Daughter-in law; 50=Other Relative; 51=Paid caregiver; 52=Friends; 90= Other, specify; -999= Missing; 53=Roommate; 54=Supervisor; 55=mother's boyfriend; 56=other parental figure; 57=Summary; 58=counselor ; 59 = other female relative; 60 = other male relative; 61 = non-relative ; ;62=Maternal Aunt; 63=Maternal Uncle; 64=Maternal Cousin; 65 = Paternal Aunt; 66=Paternal Uncle; 67=Paternal Cousin ;68=Biological/Adoptive Mother and Grandmother; 69=Biological/Adoptive Mother and Stepmother and Grandmother; 70=Biological/Adoptive Mother and Grandmother and Foster Father; 71=Biological/Adoptive Mother and Stepmother and Foster Mother; 72=Biological/Adoptive Mother and Foster Mother; 73=Biological/Adoptive Mother and Biological/Adoptive Father; 74=Biological/Adoptive Mother and Stepmother and Biological/Adoptive Father; 75=Biological/Adoptive Mother and Other; 76=Biological/Adoptive Mother and Stepmother and Stepfather; 77=Biological/Adoptive Mother and Stepfather; 78=Biological/Adoptive Mother and Grandfather; 79=Biological/Adoptive Mother and Stepmother and Foster Father; 80=Biological/Adoptive Mother and Stepmother; 81=Guardian, female; 82=Other female; 83=Guardian, male; 84=Other male; 85=Other/Grandparent/Nannyinfrmnt2
esfrefIntegerRecommendedReferral for clinical care given0::20=N/A; 1=no; 2=yes
esfltrIntegerRecommendedEnd of study letter sent0::20=N/A; 1=no; 2=yes
cmp001IntegerRecommendedDid the subject complete the study?
0;1
0=No; 1=Yeseoscomp, subsum_all_complete
cmp003IntegerRecommendedReason for early termination (Use codes below. Select one, then describe in Q4.)
1::26;-9
1=Withdrew consent; 2=Medical reason (AE, abnormal lab, intercurrent illness, etc.); 3=Disease progression; 4=Non-compliance with protocol or treatment; 5=Subject requires prohibited medication; 6=Termination of study by sponsor; 7=Subject terminated at discretion of the investigator or sponsor; 8=Other; 9=Death; 10=Protocol violation; 11=Lost to follow up; 12=CGI-I>5; 13=Screen Failure; 15=Other; -9=Unknown; 14=Non compliance with study drug; 16=Dissatisfied with treatment setting; 17=Experiencing unsatisfactory side effects; 18 = Subject ineligible; 19= Study too burdensome; 20= Dissatisfied with clinical response to treatment; 21= Unable to follow procedures, visit schedule, etc.; 22=Significant adverse event; 23=Participant uncooperative; 24 = Participant request; 25=Provider/Family request; 26=Did not continue to meet study criteriaeosreas
cmp004String250RecommendedDescribe reason for early terminationeosother
eff_failIntegerRecommendedEfficacy Failure based on 3 Criteria (psychiatric hospitalization, deterioration on CGI scale, PANSS change PANSS_C)0;10=No; 1=Yes
iefffailIntegerRecommendedSubject Indicator for efficacy failure (3 criteria)0;10=Otherwise; 1=Subject had efficacy failure (4 criteria) at least once
time2IntegerRecommendedTime Trial 20 :: 999
efffail2IntegerRecommendedEfficacy Failure based on 4 Criteria (psychiatric hospitalization, deterioration on CGI scale, PANSS change PANSS_C, or RTDA3 value of '01=positive symptoms', '02= Negative symptoms', '03 = mood symptoms', '04= other efficacy/inadequate therapeutic effect0;10=No; 1=Yes
ieffail2IntegerRecommendedSubject Indicator for efficacy failure (4 criteria)0;10=Otherwise; 1=Subject had efficacy failure (4 criteria) at least once
time_ef2IntegerRecommendedTime To Efficacy Failure (4 criteria), In Days0::260
site_pString5RecommendedPseudo Site: Pooled According To Size05;16;28;37;p1;p2;p3;p4;p5;p6
site_ppString5RecommendedPseudo Site: Pooled According to Size and Ethnicitypp1;pp2;pp3;pp4;pp5;pp6
ittIntegerRecommendedIntent-To-Treat Population0;10=Not in Intent-to-treat population; 1=In intent-to-treat population
eeIntegerRecommendedEfficacy Evaluable Population0;10=Not in Efficacy Evaluable population; 1=In Efficacy Evaluable population
ppIntegerRecommendedPer Protocol Population0;10=Not in Per Protocol population; 1=In Per Protocol population
version_formString100RecommendedForm usedvers
daysrzIntegerRecommendeddays since randomizationdays
fseqnoIntegerRecommendedSequence Number0::999The FSEQNO variable in the ADJ form has a special interpretation compared to other forms. For example, ADJ FSEQNO of '1' can be thought of as being '001', FSEQNO of '2' can be thought of as being '002', and FSEQNO of '3' can be thought of as being '003'. The first digit of FSEQNO relates to the corresponding ENF sequence number at that visit and the third digit relates to the specific adjudicator who completed the adjudication form.
phaseIntegerRecommendedPhase9 =follow up
enddy_2IntegerRecommendedNumber of days from study baseline to end date of phase 2fupdate
eos01IntegerRecommendedDid the patient complete the study? (e.g.:attended all visits up to week 36)0;10=No; 1=Yesfhx10a
eos06IntegerRecommendedDay SignedNumber of days from study baseline to date of signed End of Study formfhx10b
eos04dIntegerRecommendedDay of patient death:Number of days from study baseline to date of death
completedIntegerRecommendedChecks if completed0::20=No; 1=Yes; 2=Yes, lost
tcdateDateRecommendedDate of study treatment completioncmp002
possvisitIntegerRecommendedPossible number of visits
trtexcodIntegerRecommendedTreatment Exit Code1;2;3;4;5;6;7;8;9;10;11;12;131=End of Study � Completed ALL Months of Study Treatment; 2=Patient decision � Lack of Efficacy; 3=Patient decision � Side Effects; 4=Patient decision � Refusal of Study Treatment � Part of Illness; 5=Patient decision � Refusal of Study Treatment � No Further Reason; 6=Patient decision � Wants Different Treatment or Treatment Elsewhere; 7=Unwilling/Unable to Comply with Study Treatment Demands; 8=Doctor decision � Lack of Efficacy; 9=Doctor decision � Side Effects; 10=Intervening Illness or Treatment; 11=Moved or Other Administrative Reason; 12=Lost to Follow-Up � No Further Reason; 13=Deceased
trtexdayIntegerRecommendedTreatment Exit Days from Visit 1
stexcodIntegerRecommendedStudy Exit Code21;22;23;24;25;26;2721=End of Study � Completed ALL Months of Assessment; 22=Lost to Follow-Up; 23=Patient Refused to Continue in Treatment and Study; 24=Patient Refused to Continue in Study; 25=Intervening Illness Interferes w/ Continuing; 26=Moved or Other Administrative; 27=Deceased
stexdayIntegerRecommendedStudy Exit Days from Visit 1
intrtIntegerRecommendedTreatment Status Code0::20=Baseline; 1=In Treatment; 2=In Follow-up
trtgrp_pIntegerRecommendedTreatment Group1;21=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
days_visit1IntegerRecommendedDays from Visit 1dav1dhs
visnumFloatRecommendedNumeric Visit Number-1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; 1000=all visits
dthdateDateRecommendedDate of deatheosdthdt
lstalvdtDateRecommendedDate subject was last known to be aliveeosalvdt
aef001IntegerRecommendedAdverse Event number1::99; -9-9=unknowneosaeref
icfwddtDateRecommendedDate subject withdrew consenteoswthdt
eosunblString2RecommendedWas the subjects treatment assignment unblinded?Y;NY=Yes; N=No
eosrunblString200RecommendedReason for unblinding
subsum_mriIntegerRecommendedDid the participant have the MRI scan indicated in the protocol?0;10=No; 1=Yes
subsum_socog_testIntegerRecommendedDid the participant have the social cognition and neuropsychological assessments completed as indicated in the protocol?0;10=No; 1=Yes
ayenIntegerRecommendedHas the subject had any adverse events during this study?0;10 = No; 1 = Yessubsum_any_ae
aeString250RecommendedAdverse event Descriptionsubsum_ae_notes
commentsString4,000RecommendedComments about assessmentsubsum_notes
doa_futdtString20RecommendedFuture date entered (Assessment)
dodeString10RecommendedDate of Data Entrysubsum_dode
dode_futdtString20RecommendedFuture date entered (Data Entry)subsum_dode_futdt
form_completedIntegerRecommendedWas the form completed?1;21=Yes; 2=Nosubsum_form_completed
form_explainIntegerRecommendedWhy was this form not completed?86::9999=Participant unable to complete due to cognitive impairment; 98=Participant unable to complete due to physical impairment; 97=Participant refused to begin/finish; 96=Participant completed but with less than best effort; 95=Participant unable to be contacted; 94=Participant deceased; 93=Participant withdrew consent; 92=Time constraints; 91=Rater forgot to administer; 90=Missed appointment; 89=Participant was terminated from study; 88=Other;87 = Not Done (reason unspecified); 86 = Not Applicablesubsum_explain
other_reason_ncString100RecommendedOther reason form was not completedsubsum_other_reason_nc
assessment_completeIntegerRecommendedComplete?0::20=Incomplete; 1=Unverified; 2=Completeparticipant_checklist_complete
stdor7IntegerRecommendedDropout-other reason1;01 = Yes; 0=No
stdor7_sString255RecommendedStage V: Dropout-other reason, spec.
stdor3_sString100RecommendedStage V: Dropout-consent withdrawn, sp.
stdor3IntegerRecommendedDropout-consent withdrawn1;01 = Yes; 0-No
termin_dayIntegerRecommendedDays since baseline that clinic officially terminated the subject
eterm_03IntegerRecommendedLost to follow up0;10=No; 1=Yes
aescodeIntegerRecommendedStaff code number of person completing this form
hardcodeString1,200RecommendedSignificant Protocol ViolationTextual description of the protocol violation
cmp004_screenIntegerRecommendedWas the subject a screen failure0;10=No; 1=Yes
failreasIntegerRecommendedReason for Screen Failure1::121=Patient did not want to change current typical antipsychitic med; 2 = Patient did not want to change current atypical antipsychitic med; 3 = Patient did not meet inclusion or exclusion criteria; 4 = Patient not able to make informed consent; 5 = Patient refusal - other reason; 6 = Other; 7=NA; 8=Did not meet diagnostic criteria; 9= Clinical or unstable medical disorder; 10= Moderate or severe substance use;11 =Pregnant, breastfeeding or planning on becoming pregnant; 12=Currently taking broccoli supplement
cmp005_descString100RecommendedOther reason for screen failure
cmp005_dateDateRecommendedDate of screen failure
cmp003_dateIntegerRecommendedDate of early withdrawal
cmp003_timeString25RecommendedThe participant was withdrawn prematurely from the study closest tovisit/week
cmp006_etIntegerRecommendedDid the subject complete an Early Termination Visit0;10=No; 1=Yes
cmp006_dateDateRecommendedDate of Early Termination Visit
phasescompletedString15RecommendedPhase completed
lastvisitIntegerRecommendedThis variable indicates whether the assessment was the last for the subject. For the acute phase, this is generally at week 12, but the last weekly visit will vary for early terminators.0;10 = no; 1 = yes
term_consent_withdrawString200RecommendedParticipant Withdrew Consent - Please Specify
reason_for_rejectionString250RecommendedPlease, specify reason for rejection or disapproval:
ptaefIntegerRecommendedAEF Completed?0;1(Yes=1; No=0)
trmssrsnString250RecommendedTermination of participation by sponsor Reason
iecsigIntegerRecommendedInvestigator signature on form.0;10=No; 1= Yes
sigd1IntegerRecommendedPhysician/PI signature date (days since randomization)
enroll_notIntegerRecommendedReason for not being in study1::71= Not eligible;2= Not interested;3= Withdrawn -- Participant choice;4= Withdrawn -- Investigator choice;5= Withdrawn -- Lost to follow-up;6= Death; 7 = Withdrawn -- Patient/Family choice
phase_1IntegerRecommendedscp rcp phase 11::6;-71=Acute; 2=Continuation; 3=Maintenance; 4=Termination; 5 = Extension; 6 = Discontinuation/Tapering -7=Refused
argcontIntegerRecommendedHas the subject agreed to continue to come in for scheduled visits even thought he/she is no longer following the study protocol?0;10 = No; 1 = Yes
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

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Distribution for DataStructure: endstudy01 and Element:
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