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Description
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Notes
Data Structures with shared data
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Early Termination Form

et

01

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Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*
src_subject_idString20RequiredSubject ID how it's defined in lab/projectbid, id, newid, patid, randid, record_id, subject_id, subjectid
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired fielderltrmdt, eterm_dot
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.dema1
genderString20RequiredSex of the subjectM;FM = Male; F = Femaledema2
eterm_01IntegerRecommendedFound to have been ineligible at time of enrollment0;10=No; 1=Yesinel
eterm_02IntegerRecommendedMoved from the area0;10=No; 1=Yesmoved
eterm_03IntegerRecommendedLost to follow up0;10=No; 1=Yesatf_6_7, ctf_6_7, eltf
eterm_03_aDateRecommendedDate of last contact
eterm_04IntegerRecommendedParticipant missed more than 2 weeks of study medications0;10=No; 1=Yesmiss_med
eterm_04_aIntegerRecommendedOther non-adherence to study procedures0;10=No; 1=Yesatf_6_6, ctf_6_6, non_adh
eterm_05aIntegerRecommendedPatient choice. Found research too burdensome0;10=No; 1=Yesburden
eterm_05bIntegerRecommendedPatient choice. Believes depression is sufficiently improved0;10=No; 1=Yesimprove
eterm_05cIntegerRecommendedPatient choice. Didn't want to continue taking medications0;10=No; 1=Yesno_med
eterm_05dIntegerRecommendedPatient choice. Believed treatment not working0;10=No; 1=Yesnot_work
eterm_05eIntegerRecommendedPatient choice. Found side effects unacceptable0;10=No; 1=Yesse_unacc
eterm_05fIntegerRecommendedPatient choice. Other0;10=No; 1=Yespt_other
eterm_06aIntegerRecommendedClinician choice. Primary diagnosis changed0;10=No; 1=Yesdx_chng
eterm_06bIntegerRecommendedClinician choice. Developed general medical or surgical condition contraindicating study medications or requiring protocol to be stopped0;10=No; 1=Yesgmc_gsc
eterm_06cIntegerRecommendedClinician choice. Developed symptoms of psychosis requiring non-protocol treatment0;10=No; 1=Yespsychosi
eterm_06dIntegerRecommendedClinician choice. Developed symptoms of mania (hypo-mania) requiring non-protocol treatment0;10=No; 1=Yesemania
eterm_06eIntegerRecommendedClinician choice. Developed other symptoms requiring non-protocol treatment0;10=No; 1=Yesother_sx
eterm_06fIntegerRecommendedClinician choice. Patient became danger to self0;10=No; 1=Yesdanger_s
eterm_06gIntegerRecommendedClinician choice. Patient became danger to others0;10=No; 1=Yesdanger_o
eterm_06hIntegerRecommendedClinician choice. Hospitalized for worsening depression0;10=No; 1=Yeswrse_dep
eterm_06iIntegerRecommendedClinician choice. Hospitalized for suicidal ideation0;10=No; 1=Yessuic_ide
eterm_06jIntegerRecommendedClinician choice. Became pregnant0;10=No; 1=Yesctf_6_5, pregnant
eterm_06kIntegerRecommendedClinician choice. Lack of sufficient efficacy at maximally tolerated doses0;10=No; 1=Yesefficacy
eterm_06lIntegerRecommendedClinician choice. Unacceptable side effects that could not be resolved0;10=No; 1=Yesse_unres
eterm_07IntegerRecommendedClinician choice. Committed Suicide0;10=No; 1=Yesesuicide
eterm_08IntegerRecommendedClinician choice. Death not due to suicide0;10=No; 1=Yesedeath
eterm_09IntegerRecommendedClinician choice. Other0;10=No; 1=Yeseother
eterm_commentsString800Recommendedcomments sectionterm_notes2
eterm6prgDateRecommendedpregnant date
visitidIntegerRecommendedMetaTrial Visit IDSystem variable: unique code for each type of visit -use to merge files
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.
visdayIntegerRecommendedNumber of days from study baseline to date of visitdate, fwfa0b
fwfa1IntegerRecommendedDate of study withdrawal
baseline_q_002IntegerRecommendedDate of withdrawalfwfa2
version_formString100RecommendedForm usedform_name, vers
daysrzIntegerRecommendeddays since randomizationstudyday, visitdt
siteString100RecommendedSiteStudy Sitesite_uid, siteid
stusdyString40RecommendedStudy IDsttx_studyid, studyid
visitString50RecommendedVisit nameCharacter description of each type of visitatf_3, ctf_3, int1, interval, sttx_interval, visit_name
completedIntegerRecommendedChecks if form is completed0::20=No; 1=Yes; 2=Yes, lostformcomp, frmcomp, sttx_frmcomp
subtrial_nameIntegerRecommendedName of subtrial1::31=Crossover; 2=Guanfacine; 3= Open Label MPH
trm_q1IntegerRecommendedDate of last clinic visit in days from the randomization/enrollment date (TRM_Q1 = Date of last clinic visit - randomization/enrollment date)at3da, ct3da
weektermString20RecommendedLast visit attendedltf_date, sttx_weekterm
trm_q3IntegerRecommendedDate of study termination in days from the randomization/enrollment date (TRM_Q3 = Date of study termination - randomization/enrollment date)at4da, ct4da, dateterm, sttx_termdat_x
trm_q4IntegerRecommendedDid subject complete visit D4(Crossover)/G8(Guanfacine)/D12(MPH Open Label)0;10=No; 1=Yes
trm_q5IntegerRecommendedReason for early termination1::201=Toxicity or side effects related to study medication 2=Medical reason unrelated to study medication 3=Termination by principal investigator because of non medical reasons 4=Failed to return to clinic 5=Declined study participation 6=Moved from area 7 = Death 8 = Subject no longer eligible to participate 9 = School unable/no longer willing to participate 10 = Other; 11=Lost to follow up; 12=Long wait for Parent training class to begin; 13=Not eligible to continue due to reaction in ADHD symptoms; 14=Parents/guardians satisfied with improvement/more able to cope following Parent Training; 15=Parents/guardians did not want child on medication; 16=Subject no longer meets entry criteria; 17 = Behavior deterioration; 18 = Placebo responder; 19 = MPH non-responder in titration; 20=Behavior deteriorationsttx_termreas
session_idString20Recommendedsession ID/screening IDscreeningid
prtendIntegerRecommendedSubject prticipation has ended1;21=Yes; 2=No
fnldspIntegerRecommendedFinal Disposition1::5;991=Subject completed the study; 2=Subject died; 3=Subject early terminated; 4=Subject withdrew consent prior to end of study; 5=Subject lost to follow up; 99=Othercomplete, sttx_complete
erldscrsIntegerRecommendedEarly Termination Type1::61=Termination of participation by site investigator; 2=Termination of participation by study sponsor; 3 = Non-Compliance; 4 = Intolerance; 5 = Lack of Efficacy; 6 = Administrative
erldscsiIntegerRecommendedTermination of participation by SI Reason1::4;991=Non compliance; 2=Suicidal ideation and/or behavior; 3=Worsening of disease; 4=Adverse events; 99=Other specify
erldscsoString250RecommendedReason for Early Termination Other (specify)sttx_specify, term_other_specify
trmssrsnString250RecommendedTermination of participation by sponsor Reason
icfwddtDateRecommendedDate subject withdrew consent
icfwaeIntegerRecommendedReason ICF Withdrawn: Adverse Eventatf_6_2, ctf_6_2
icfwaeidIntegerRecommendedReason ICF Withdrawn: AE ID
icfwtrvlIntegerRecommendedReason ICF Withdrawn: Travel Difficulties
icfweffIntegerRecommendedReason ICF WIthdrawal: perceicved lack of efficacy
icfwtrlIntegerRecommendedReason ICF Withdrawn: enrolled into other study
icfwothIntegerRecommendedReason ICF Withdrawn: Otheratf_6_9, ctf_6_9
icfwothsString250RecommendedReason ICF Withdrawn: Other textatf_6_9s, ctf_6_9s
fndslcdtDateRecommendedDate of last successful contact
fnldspotString250RecommendedFinal Disposition Other Specify
studyString100RecommendedStudy
weekFloatRecommendedWeek in level/study99=week 10-week 14week1
reason1IntegerRecommendedPrimary reason for exit1::1601 = Refused new treatment due to lack of efficacy;02 = Unnacceptable side effects;03 = Committed suicide/suicide attempt;04 = Developed general medical or surgical condition that required protocol to be stopped;05 = Developed symptoms requiring non-protocol treatment (e.g. psychosis, mania, etc.);06 = Moved from the area;07 = Found research too burdensome;08 = Patient withdrew from study with no reason given;09 = Hamilton score <20 at week 0;10 = Patient became pregnant and continuation of treatment is contraindicated (enter due date);11 = Failed to return to clinic/lost contact (enter date of last contact);12 = Completed Follow-up; 9 = Non-Compliance: a. Non-adherence; 10 = Non-Compliance: b. Refused; 11 = Intolerance: a. Mood; 12 = Intolerance: b. Antipsychotic Medication; 13 = Intolerance: c. Medical; 14 = Lack of Efficacy: a. Depression; 15 = Lack of Efficacy: b. Mania; 16 = Administrative: a. Administrative Reasons
reason2IntegerRecommendedSecondary reason for exit1::1601 = Refused new treatment due to lack of efficacy;02 = Unnacceptable side effects;03 = Committed suicide/suicide attempt;04 = Developed general medical or surgical condition that required protocol to be stopped;05 = Developed symptoms requiring non-protocol treatment (e.g. psychosis, mania, etc.);06 = Moved from the area;07 = Found research too burdensome;08 = Patient withdrew from study with no reason given;09 = Hamilton score <20 at week 0;10 = Patient became pregnant and continuation of treatment is contraindicated (enter due date);11 = Failed to return to clinic/lost contact (enter date of last contact);12 = Completed Follow-up; 9 = Non-Compliance: a. Non-adherence; 10 = Non-Compliance: b. Refused; 11 = Intolerance: a. Mood; 12 = Intolerance: b. Antipsychotic Medication; 13 = Intolerance: c. Medical; 14 = Lack of Efficacy: a. Depression; 15 = Lack of Efficacy: b. Mania; 16 = Administrative: a. Administrative Reasons
reason3IntegerRecommendedTertiary reason for exit1::1601 = Refused new treatment due to lack of efficacy;02 = Unnacceptable side effects;03 = Committed suicide/suicide attempt;04 = Developed general medical or surgical condition that required protocol to be stopped;05 = Developed symptoms requiring non-protocol treatment (e.g. psychosis, mania, etc.);06 = Moved from the area;07 = Found research too burdensome;08 = Patient withdrew from study with no reason given;09 = Hamilton score <20 at week 0;10 = Patient became pregnant and continuation of treatment is contraindicated (enter due date);11 = Failed to return to clinic/lost contact (enter date of last contact);12 = Completed Follow-up; 9 = Non-Compliance: a. Non-adherence; 10 = Non-Compliance: b. Refused; 11 = Intolerance: a. Mood; 12 = Intolerance: b. Antipsychotic Medication; 13 = Intolerance: c. Medical; 14 = Lack of Efficacy: a. Depression; 15 = Lack of Efficacy: b. Mania; 16 = Administrative: a. Administrative Reasons
lcdateIntegerRecommendedDate of last contact (number of days)
duedateString30RecommendedDue datedue_date
withdraw_reqIntegerRecommendedWritten withdrawal request0;10=No;1=Yesatf_6_8, ctf_6_8, withdraw
phaseIntegerRecommendedPhase9 =follow up
pmt1IntegerRecommendedPremature Termination in Phase I0;10 = No; 1 = Yesterm_premature_yn
pmt1wkIntegerRecommendedWeek of Phase 1 Premature Termination3::123 = Week 3; 12=Week 12
pmt2IntegerRecommendedPremature Termination in Phase II0;10 = No; 1 = Yes
pmt2wkIntegerRecommendedWeek of Phase 2 Premature Termination12::3312 = Week 12; 15 = Week 15; 16 = Week 16; 18 = Week 18; 20 = Week 20; 22 = Week 22; 24 = Week 24; 26 = Week 26; 27 = Week 27; 28 = Week 28; 32 = Week 32; 33 = Week 33
vis_typeIntegerRecommendedVisit type0::21=Phone; 0=doctor's office; 2=No, not phone interviewphone
ptchoiceIntegerRecommendedPatient choice0;10=No; 1=Yes
physdisIntegerRecommendedClinician choice0;10=No; 1=Yes
imputationIntegerRecommendedIndicator noting imputed data set number1::20
date_updatedDateRecommendedDate record updatededit_date
days_dischargeIntegerRecommendedDays from baseline to program discharge
visitdayIntegerRecommendedday of visitsttx_visitdat_x
trtgroupString2RecommendedTreatment GroupN1;N2;R1;R2;R3N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
ci_enrolledIntegerRecommendedParticipant enrolled0;10=No; 1=Yesenrolled
cmp004String250RecommendedDescribe reason for early terminationearlytrm
termination_dateDateRecommendedTermination Date (DD/MM/YYYY)term_termination_date
term_early_withdrawIntegerRecommendedEarly Termination/Withdrawal Checklist:1::1001 = Patient withdrew consent - Please Specify ; 02 = Baseline screening started, no longer eligible - Please Specify ; 03 = Unable to contact ; 04 = Change in physical health - Please Specify ; 05 = Hospitalized and unavailable ; 06 = Could not tolerate MRI ; 07 = Patient deceased (Enter date, town -Adverse Events) ; 08 = Withdrawn by study psychiatrist - Please Specify ; 09 = Patient relocated/unavailable for appointments ; 10 = Other, Specify Reason Below
term_consent_withdrawString50RecommendedParticipant Withdrew Consent - Please Specifyatf_6_8s, ctf_6_8s
term_no_longer_elgString50RecommendedBaseline Screening Started, No Longer Eligible - Please Specify
term_change_healthString50RecommendedChange in Physical Health - Please Specify
term_psych_withdrawtermString50RecommendedWithdrawn by Study Psychiatrist - Please Specify
term_deceased_dateDateRecommendedParticipant Deceased - Date (DD/MM/YYYY)
commentsString4,000RecommendedComments about assessmentterm_notes
doa_futdtString20RecommendedFuture date entered (Assessment)term_dode_futdt
dodeString10RecommendedDate of Data Entryterm_dode
dode_futdtString20RecommendedFuture date entered (Data Entry)term_dode_futdt2_006
form_completedIntegerRecommendedWas the form completed?1;21=Yes; 2=Noterm_form_complete
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 Applicableterm_explain
other_reason_ncString100RecommendedOther reason form was not completedterm_other_reason_nc
assessment_completeIntegerRecommendedComplete?0::20=Incomplete; 1=Unverified; 2=Completetermination_checklist_complete
protocol_summaryString2,000RecommendedProtocol summaryatf_6_6s, ctf_6_6s
saps_ad10IntegerRecommendedRater number
aeString250RecommendedAdverse event Descriptionatf_6_2s, ctf_6_2s
continu_ph_eIntegerRecommendedPatient entered continuation phase0;10=No; 1=Yesatf_1
continu_ph_compIntegerRecommendedPatient completed continuation phase0;10=No; 1=Yesctf_2
acute_ph_cIntegerRecommendedPatient completed acute phase0;10=No; 1=Yesatf_2
atf_6_1IntegerRecommendedReason Withdrawn: insufficient responses0;10=No; 1=Yesctf_6_1
ctf_1IntegerRecommendedSubject received extension phase packet0;10=No; 1=Yes
term_deceased_townString25RecommendedParticipant Deceased - Town
term_psych_withdrawString100RecommendedWithdrawn by Study Psychiatrist - Please Specify
days_baselineIntegerRecommendedDays since baseline
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
me2IntegerRecommendedStatus0;10 = Past [Inactive]; 1 = Active
pregn_01bIntegerRecommendedClinical Termination0;10=No; 1=Yes
daysondoseIntegerRecommendedTotal days on dose=Stopdays-startdays+1
statusString50RecommendedStatus
completerIntegerRecommendedCompleted 9 Week Protocol0;10=No; 1=Yes
compl3wkIntegerRecommendedActive at Week 30;10=No; 1=Yes
rreltrtIntegerRecommendedPast treatment0::30 = none;1 = outpatient;2 = inpatient;3 = both
study_drug_teamString30RecommendedStudy drugBaseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA
dayfinlIntegerRecommendedStudy day final assessment was completed
trttypIntegerRecommendedTreatment type1::31 = CBT; 2 = PT; 3 = PT and CBT
sc3c_trtdropIntegerRecommendedReason for termination: C. Treatment Drop-Out Date (days from baseline)
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:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
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  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
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Distribution for DataStructure: et01 and Element:
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