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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Early Termination Form

2,269 Shared Subjects

N/A
Clinical Assessments
Exit Form
02/27/2015
et01
10/26/2017
View Change History
01
Definition
Submission Template
Query Element Name Data Type Size Required Description Value Range Notes Aliases
subjectkey GUID Required The NDAR Global Unique Identifier (GUID) for research subject NDAR*
src_subject_id String 20 Required Subject ID how it's defined in lab/project bid, id, newid, patid, randid, record_id, subject_id, subjectid
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY erltrmdt, eterm_dot
interview_age Integer Required Age in months at the time of the interview/test/sampling/imaging. 0::1440 Age 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
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported dema2, gender
Query eterm_01 Integer Recommended Found to have been ineligible at time of enrollment 0;1 0=No; 1=Yes inel
Query eterm_02 Integer Recommended Moved from the area 0;1 0=No; 1=Yes moved
Query eterm_03 Integer Recommended Lost to follow up 0;1 0=No; 1=Yes atf_6_7, ctf_6_7, eltf
eterm_03_a Date Recommended Date of last contact
Query eterm_04 Integer Recommended Participant missed more than 2 weeks of study medications 0;1 0=No; 1=Yes miss_med
Query eterm_04_a Integer Recommended Other non-adherence to study procedures 0;1 0=No; 1=Yes atf_6_6, ctf_6_6, non_adh
Query eterm_05a Integer Recommended Patient choice. Found research too burdensome 0;1 0=No; 1=Yes burden
Query eterm_05b Integer Recommended Patient choice. Believes depression is sufficiently improved 0;1 0=No; 1=Yes improve
Query eterm_05c Integer Recommended Patient choice. Didn't want to continue taking medications 0;1 0=No; 1=Yes no_med
Query eterm_05d Integer Recommended Patient choice. Believed treatment not working 0;1 0=No; 1=Yes not_work
Query eterm_05e Integer Recommended Patient choice. Found side effects unacceptable 0;1 0=No; 1=Yes se_unacc
Query eterm_05f Integer Recommended Patient choice. Other 0;1 0=No; 1=Yes pt_other
Query eterm_06a Integer Recommended Clinician choice. Primary diagnosis changed 0;1 0=No; 1=Yes dx_chng
Query eterm_06b Integer Recommended Clinician choice. Developed general medical or surgical condition contraindicating study medications or requiring protocol to be stopped 0;1 0=No; 1=Yes gmc_gsc
Query eterm_06c Integer Recommended Clinician choice. Developed symptoms of psychosis requiring non-protocol treatment 0;1 0=No; 1=Yes psychosi
Query eterm_06d Integer Recommended Clinician choice. Developed symptoms of mania (hypo-mania) requiring non-protocol treatment 0;1 0=No; 1=Yes emania
Query eterm_06e Integer Recommended Clinician choice. Developed other symptoms requiring non-protocol treatment 0;1 0=No; 1=Yes other_sx
Query eterm_06f Integer Recommended Clinician choice. Patient became danger to self 0;1 0=No; 1=Yes danger_s
Query eterm_06g Integer Recommended Clinician choice. Patient became danger to others 0;1 0=No; 1=Yes danger_o
Query eterm_06h Integer Recommended Clinician choice. Hospitalized for worsening depression 0;1 0=No; 1=Yes wrse_dep
Query eterm_06i Integer Recommended Clinician choice. Hospitalized for suicidal ideation 0;1 0=No; 1=Yes suic_ide
Query eterm_06j Integer Recommended Clinician choice. Became pregnant 0;1 0=No; 1=Yes ctf_6_5, pregnant
Query eterm_06k Integer Recommended Clinician choice. Lack of sufficient efficacy at maximally tolerated doses 0;1 0=No; 1=Yes efficacy
Query eterm_06l Integer Recommended Clinician choice. Unacceptable side effects that could not be resolved 0;1 0=No; 1=Yes se_unres
Query eterm_07 Integer Recommended Clinician choice. Committed Suicide 0;1 0=No; 1=Yes esuicide
Query eterm_08 Integer Recommended Clinician choice. Death not due to suicide 0;1 0=No; 1=Yes edeath
Query eterm_09 Integer Recommended Clinician choice. Other 0;1 0=No; 1=Yes eother
eterm_comments String 2,750 Recommended comments section term_notes2
eterm6prg Date Recommended pregnant date
Query visitid Integer Recommended MetaTrial Visit ID System variable: unique code for each type of visit -use to merge files
Query fseqno Integer Recommended Sequence Number 0::999 The 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.
Query visday Integer Recommended Number of days from study baseline to date of visit date, fwfa0b
Query fwfa1 Integer Recommended Date of study withdrawal
Query baseline_q_002 Integer Recommended Date of withdrawal fwfa2
version_form String 121 Recommended Form used/assessment name form_name, vers
Query daysrz Integer Recommended days since randomization studyday, visitdt
Query site String 101 Recommended Site Study Site site_uid, siteid
Query stusdy String 40 Recommended Study ID sttx_studyid, studyid
Query visit String 60 Recommended Visit name atf_3, ctf_3, int1, interval, sttx_interval, visit_name
Query completed Integer Recommended Checks if completed 0::3 0=No; 1=Yes; 2=Yes, lost; 3=Unverified formcomp, frmcomp, sttx_frmcomp
Query subtrial_name Integer Recommended Name of subtrial 1::3 1=Crossover; 2=Guanfacine; 3= Open Label MPH
Query trm_q1 Integer Recommended Date of last clinic visit in days from the randomization/enrollment date (TRM_Q1 = Date of last clinic visit - randomization/enrollment date) at3da, ct3da
weekterm String 20 Recommended Last visit attended ltf_date, sttx_weekterm
Query trm_q3 Integer Recommended Date 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
Query trm_q4 Integer Recommended Did subject complete visit D4(Crossover)/G8(Guanfacine)/D12(MPH Open Label) 0;1 0=No; 1=Yes
Query trm_q5 Integer Recommended Reason for early termination 1::20 1=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 deterioration sttx_termreas
session_id String 20 Recommended session ID/screening ID screeningid
Query prtend Integer Recommended Subject prticipation has ended 1;2 1=Yes; 2=No
Query fnldsp Integer Recommended Final Disposition 1::5;99 1=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=Other complete, sttx_complete
Query erldscrs Integer Recommended Early Termination Type 1::6 1=Termination of participation by site investigator; 2=Termination of participation by study sponsor; 3 = Non-Compliance; 4 = Intolerance; 5 = Lack of Efficacy; 6 = Administrative
Query erldscsi Integer Recommended Termination of participation by SI Reason 1::4;99 1=Non compliance; 2=Suicidal ideation and/or behavior; 3=Worsening of disease; 4=Adverse events; 99=Other specify
Query erldscso String 250 Recommended Reason for Early Termination Other (specify) otherdesc, sttx_specify, term_other_specify
trmssrsn String 250 Recommended Termination of participation by sponsor Reason
icfwddt Date Recommended Date subject withdrew consent
Query icfwae Integer Recommended Reason ICF Withdrawn: Adverse Event atf_6_2, ctf_6_2
Query icfwaeid Integer Recommended Reason ICF Withdrawn: AE ID
Query icfwtrvl Integer Recommended Reason ICF Withdrawn: Travel Difficulties
Query icfweff Integer Recommended Reason ICF WIthdrawal: perceicved lack of efficacy
Query icfwtrl Integer Recommended Reason ICF Withdrawn: enrolled into other study
Query icfwoth Integer Recommended Reason ICF Withdrawn: Other atf_6_9, ctf_6_9
icfwoths String 250 Recommended Reason ICF Withdrawn: Other text atf_6_9s, ctf_6_9s
fndslcdt Date Recommended Date of last successful contact
fnldspot String 250 Recommended Final Disposition Other Specify
study String 100 Recommended Study; The code for each individual study
Query week Float Recommended Week in level/study 99=week 10-week 14 week1
Query reason1 Integer Recommended Primary reason for exit 1::16 01 = 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
Query reason2 Integer Recommended Secondary reason for exit 1::16 01 = 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
Query reason3 Integer Recommended Tertiary reason for exit 1::16 01 = 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
Query lcdate Integer Recommended Date of last contact (number of days)
Query duedate String 30 Recommended Due date due_date
Query withdraw_req Integer Recommended Written withdrawal request 0;1 0=No;1=Yes atf_6_8, ctf_6_8, withdraw
Query phase Integer Recommended Phase 9 =follow up
Query pmt1 Integer Recommended Premature Termination in Phase I 0;1 0 = No; 1 = Yes term_premature_yn
Query pmt1wk Integer Recommended Week of Phase 1 Premature Termination 3::12 3 = Week 3; 12=Week 12
Query pmt2 Integer Recommended Premature Termination in Phase II 0;1 0 = No; 1 = Yes
Query pmt2wk Integer Recommended Week of Phase 2 Premature Termination 12::33 12 = 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
Query vis_type Integer Recommended Visit type 0::2 1=Phone/remote; 0=doctor's office/In person; 2=No, not phone interview phone
Query ptchoice Integer Recommended Patient choice 0;1 0=No; 1=Yes
Query physdis Integer Recommended Clinician choice 0;1 0=No; 1=Yes
Query imputation Integer Recommended Indicator noting imputed data set number 1::20
date_updated Date Recommended Date record updated edit_date
Query days_discharge Integer Recommended Days from baseline to program discharge
Query visitday Integer Recommended day of visit sttx_visitdat_x
Query trtgroup String 2 Recommended Treatment Group N1;N2;R1;R2;R3 N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
Query ci_enrolled Integer Recommended Participant enrolled 0;1 0=No; 1=Yes enrolled
Query cmp004 String 500 Recommended Describe reason for early termination earlytrm
termination_date Date Recommended Termination Date (DD/MM/YYYY) term_termination_date
Query term_early_withdraw Integer Recommended Early Termination/Withdrawal Checklist: 1::10 01 = 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_withdraw String 200 Recommended Participant Withdrew Consent - Please Specify atf_6_8s, ctf_6_8s
term_no_longer_elg String 50 Recommended Baseline Screening Started, No Longer Eligible - Please Specify
term_change_health String 50 Recommended Change in Physical Health - Please Specify
term_psych_withdrawterm String 50 Recommended Withdrawn by Study Psychiatrist - Please Specify
term_deceased_date Date Recommended Participant Deceased - Date (DD/MM/YYYY)
comments String 4,000 Recommended Comments about assessment term_notes
doa_futdt String 20 Recommended Future date entered (Assessment) term_dode_futdt
dode String 10 Recommended Date of Data Entry term_dode
dode_futdt String 20 Recommended Future date entered (Data Entry) term_dode_futdt2_006
Query form_completed Integer Recommended Was the form completed? 1::4 1=Yes; 2=No; 3=Unverified; 4 = N/A-Not in age range term_form_complete
Query form_explain Integer Recommended Why was this form not completed? 86::99 99=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 Applicable term_explain
other_reason_nc String 100 Recommended Other reason form was not completed term_other_reason_nc
Query assessment_complete Integer Recommended Complete? 0::2 0=Incomplete; 1=Unverified; 2=Complete termination_checklist_complete
protocol_summary String 2,000 Recommended Protocol summary atf_6_6s, ctf_6_6s
Query saps_ad10 Integer Recommended Rater number
ae String 4,000 Recommended Adverse event Description atf_6_2s, ctf_6_2s
Query continu_ph_e Integer Recommended Patient entered continuation phase 0;1 0=No; 1=Yes atf_1
Query continu_ph_comp Integer Recommended Patient completed continuation phase 0;1 0=No; 1=Yes ctf_2
Query acute_ph_c Integer Recommended Patient completed acute phase 0;1 0=No; 1=Yes atf_2
Query atf_6_1 Integer Recommended Reason Withdrawn: insufficient responses 0;1 0=No; 1=Yes ctf_6_1
Query ctf_1 Integer Recommended Subject received extension phase packet 0;1 0=No; 1=Yes
term_deceased_town String 25 Recommended Participant Deceased - Town
term_psych_withdraw String 100 Recommended Withdrawn by Study Psychiatrist - Please Specify
Query days_baseline Integer Recommended Days since baseline
Query visnum Float Recommended Numeric 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
Query me2 Integer Recommended Status 0;1 0 = Past [Inactive]; 1 = Active
Query pregn_01b Integer Recommended Clinical Termination 0;1 0=No; 1=Yes
Query daysondose Integer Recommended Total days on dose =Stopdays-startdays+1
Query status String 50 Recommended Status
Query completer Integer Recommended Completed 9 Week Protocol 0;1 0=No; 1=Yes
Query compl3wk Integer Recommended Active at Week 3 0;1 0=No; 1=Yes
Query rreltrt Integer Recommended Past treatment 0::3 0 = none;1 = outpatient;2 = inpatient;3 = both
Query study_drug_team String 30 Recommended Study drug Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA
Query dayfinl Integer Recommended Study day final assessment was completed
Query trttyp Integer Recommended Treatment type 1::3 1 = CBT; 2 = PT; 3 = PT and CBT
Query sc3c_trtdrop Integer Recommended Reason for termination: C. Treatment Drop-Out Date (days from baseline)
Query reason_notreturnfortx Integer Recommended Reason. Not returned for treatment 0;1 0 = Not primary reason; 1 = primary reason for early termination
Query reason_refusedstudytx Integer Recommended Reason. Refused study treatment 0;1 0 = Not primary reason; 1 = primary reason for early termination
Query reason_adversereaction Integer Recommended Reason. Adverse reaction 0;1 0 = Not primary reason; 1 = primary reason for early termination
Query reason_in_deterioration Integer Recommended Reason. In deterioration 0;1 0 = Not primary reason; 1 = primary reason for early termination reason_ineffectiveness_deterioration
Query reason_intercurrentillness Integer Recommended Reason. Current illness 0;1 0 = Not primary reason; 1 = primary reason for early termination
Query reason_notmeetstudycriteria Integer Recommended Reason. Criteria not met 0;1 0 = Not primary reason; 1 = primary reason for early termination
Query reason_dos_violation Integer Recommended Reason. DOS violation 0;1 0 = Not primary reason; 1 = primary reason for early termination reason_dosagemedicationerror_violation
Query reason_administrative Integer Recommended Reason. Administrative 0;1 0 = Not primary reason; 1 = primary reason for early termination
Query reason_suicidal_homicidal Integer Recommended Reason. Suicidal/homicidal 0;1 0 = Not primary reason; 1 = primary reason for early termination
Query reason_other Integer Recommended Reason. Other 0;1 0 = Not primary reason; 1 = primary reason for early termination
Query early_termination Integer Recommended Early termination 0;1 0 = No; 1 = Yes
Query clinid Integer Recommended Clinician ID eterm_06_b
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
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • 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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