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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Protocol Violators

6,473 Shared Subjects

Clinical Trial: Protocol Violators; Inclusion and Exclusion Criteria
Clinical Assessments
Treatment
05/08/2014
viol01
09/22/2023
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 CATIEID, id, pid, stepid, subjectid, subjid
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY visit_date
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.
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
Query hardcode String 1,200 Recommended Significant Protocol Violation Textual description of the protocol violation pdevdes
Query violate Integer Recommended Protocol Violation 0;1 0=No; 1-Yes
Query inc1 Integer Recommended If NO, which criteria have not been met: 18-65 years not met 0;1 0=No; 1-Yes
Query inc2 Integer Recommended If NO, which criteria have not been met: DSM-IV criteria for schizophrenia 0;1 0=No; 1-Yes
Query inc3 Integer Recommended If NO, which criteria have not been met: Appropriate for treatment with an oral drugs 0;1 0=No; 1-Yes
Query inc4 Integer Recommended If NO, which criteria have not been met: Demonstrated adequate decisional capability 0;1 0=No; 1-Yes
Query exc1 Integer Recommended If YES, which criteria have been met: Other cog. Disorder not met 0;1 0=No; 1-Yes
Query exc2 Integer Recommended If YES, which criteria have been met: Serious adverse reaction to even one of the proposed treatment arms? 0;1 0=No; 1-Yes
Query exc3 Integer Recommended If YES, which criteria have been met: In first episode of schizophrenia 0;1 0=No; 1-Yes
Query exc4 Integer Recommended If YES, which criteria have been met: Well-documented history of failure toto respond to even one of the proposed treatment arms? 0;1 0=No; 1-Yes
Query exc5 Integer Recommended If YES, which criteria have been met: Treated with clozapine for treatment resistance? 0;1 0=No; 1-Yes
Query exc6 Integer Recommended If YES, which criteria have been met: Currently stabilized on haloperidol decanoate or fluphenazine decanoate and clinically judged to require this for medication adherence? 0;1 0=No; 1-Yes
Query exc7 Integer Recommended If YES, which criteria have been met: Pregnant or currently breastfeeding 0;1 0=No; 1-Yes
Query exc9 Integer Recommended If YES, which criteria have been met: Contraindication to a study drug 0;1 0=No; 1-Yes
Query exc10 Integer Recommended If YES, which criteria have been met: Serious and unstable medical condition 0;1 0=No; 1-Yes
Query exc11 Integer Recommended If YES, which criteria have been met: Taken another investigational drug within 30 days of baseline? 0;1 0=No; 1-Yes
Query exc12 Integer Recommended If YES, which criteria have been met: Recent myocardial infarction (<6 months)? 0;1 0=No; 1-Yes
Query exc13 Integer Recommended If YES, which criteria have been met: QTc prolongation (screening ECG with QTc > 450 msec for men, QTc > 470 msec for women? 0;1 0=No; 1-Yes
Query exc14 Integer Recommended If YES, which criteria have been met: History of congenital QTc prolongation? 0;1 0=No; 1-Yes
Query exc15 Integer Recommended If YES, which criteria have been met: Sustained cardiac arrhythmia or history of sustained cardiac arrhythmia? 0;1 0=No; 1-Yes
Query exc16 Integer Recommended If YES, which criteria have been met: Uncompensated congestive heart failure? 0;1 0=No; 1-Yes
Query exc17 Integer Recommended If YES, which criteria have been met: Complete Left Bundle Branch Block (LBBB)? 0;1 0=No; 1-Yes
Query exc18 Integer Recommended If YES, which criteria have been met: First-degree heart block with PR interval > or = .22 second? 0;1 0=No; 1-Yes
Query exc19 Integer Recommended If YES, which criteria have been met: Concurrent treatment with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin..? 0;1 0=No; 1-Yes
Query exc8 Integer Recommended If YES, which criteria have been met: Tardive dyskinesia 0;1 0=No; 1-Yes
Query realtrt String 50 Recommended Actual treatment received For patients who received incorrect study drug, this is the actual treatment they received
Query rt_dur Integer Recommended Duration on incorrect study drug (days) For patients who received incorrect study drug, this is the number of days they received the incorrect study drug
Query rt_day Integer Recommended Day incorrect study drug dispensed For patients who received incorrect study drug, this is the day (in relation to the baseline visit date) they received the incorrect study drug firstdt1
Query rtphase Integer Recommended Phase 1::4 Phase in which patient received incorrect study drug; 1=1; 2=2; 1A=3; 1B=4
rtaction String 100 Recommended Action taken For patients who received incorrect study drug, this is the action taken once it was discovered
Query unbl_11a Integer Recommended Unblinded patients after successful completion of the phase 1/1A 0;1 0=No; 1-Yes
Query unbl_1b Integer Recommended Unblinded patients after successful completion of the phase 1B 0;1 0=No; 1-Yes
Query unbl_2 Integer Recommended Unblinded patients after successful completion of the phase 2 0;1 0=No; 1-Yes notblind
crcid String 40 Recommended CRC ID/ROA ID
level String 10 Recommended Treatment level pphase
Query week Float Recommended Week in level/study 99=week 10-week 14 intid, week_i
Query hand_date Integer Recommended reported date date
Query update Integer Recommended Updated form 0;1 1= yes; 0= no
Query inelg Integer Recommended Enrolled subject found to be ineligible 0;1 0=Not checked; 1=Checked
Query inelgs String 250 Recommended Ineligible reason devenrol
Query exclmed Integer Recommended Concomitant use of excluded medications 0;1 0=Not checked; 1=Checked
asispme String 200 Recommended Specify medication by name exclmeds
Query prtclmed Integer Recommended Patient was noncompliant with protocol medications 0;1 0=Not checked; 1=Checked
medication_name String 255 Recommended Name of medication medname
Query q14_cd_s String 100 Recommended Other medication: Specify medname_2
medexpl String 250 Recommended Med explanation
Query no_roa Integer Recommended ROA assessment not completed 0;1 0=Not checked; 1=Checked
Query roacntct Integer Recommended ROA Contact 1::3 1=Baseline; 2=Level exit; 3=Follow up
Query roamnth Float Recommended ROA Month
Query roa Integer Recommended ROA 0;1 0=No patient contact; 1=Form partially completed
Query roarsns String 250 Recommended ROA Form partially completed - Explain
Query raref Integer Recommended ROA - Patient refused
Query cvdr Integer Recommended Clinician cancelled scheduled visit 0;1 0=Not checked; 1=Checked
Query cvpt Integer Recommended Patient missed a scheduled clinic visit 0;1 0=Not checked; 1=Checked
Query incform Integer Recommended Visit took place, one or more forms missing or incomplete 0;1 0=Not checked; 1=Checked
Query cvoth Integer Recommended Missed visit - Other reason 0;1 0=Not checked; 1=Checked
cvoths String 250 Recommended Missed visit - Other reason explain
Query form_sc Integer Recommended SC form 0;1 0=Missing; 1=Partially completed sc
Query scrsns String 250 Recommended SC form reason
Query form_el Integer Recommended EL form 0;1 0=Missing; 1=Partially completed el
Query elrsns String 250 Recommended EL form reason
Query form_dm Integer Recommended DM form 0;1 0=Missing; 1=Partially completed dm
Query dmrsns String 250 Recommended DM form reason
Query form_crs Integer Recommended CRS form 0;1 0=Missing; 1=Partially completed crs
Query crsrsns String 250 Recommended CRS form reason
Query form_mhx Integer Recommended MHX form 0;1 0=Missing; 1=Partially completed mh, mhx
Query mhxrsns String 250 Recommended MHX form reason
Query form_phx Integer Recommended PHX form 0;1 0=Missing; 1=Partially completed phx
Query phxrsns String 250 Recommended PHX form reason
Query form_pds Integer Recommended PDS form 0;1 0=Missing; 1=Partially completed pds
pdsrsns String 250 Recommended PDS form reason
Query form_qh Integer Recommended QH form 0;1 0=Missing; 1=Partially completed qh
qhrsns String 250 Recommended QH form reason
Query form_qs Integer Recommended QS form 0;1 0=Missing; 1=Partially completed qs
qsrsns String 250 Recommended QS form reason
Query form_qc Integer Recommended QC form 0;1 0=Missing; 1=Partially completed qc, qids
qcrsns String 250 Recommended QC form reason
Query form_prs Integer Recommended PRS form 0;1 0=Missing; 1=Partially completed prs
prsrsns String 250 Recommended PRS form reason
Query form_fg Integer Recommended FG form 0;1 0=Missing; 1=Partially completed fg
fgrsns String 250 Recommended FG form reason
Query form_cc Integer Recommended CC form 0;1 0=Missing; 1=Partially completed cc
ccrsns String 250 Recommended CC form reason
Query form_ct Integer Recommended CT form 0;1 0=Missing; 1=Partially completed ct
Query ctrsns String 250 Recommended CT form reason
Query form_tc Integer Recommended TC form 0;1 0=Missing; 1=Partially completed tc
Query tcrsns String 250 Recommended TC form reason
Query other Integer Recommended Other prevent dose increase 0;1;999 0 = No; 1 = Yes pdevoth
othersp String 1,000 Recommended Other protocol deviation specify devother, pdvothtx
firstdt Date Recommended Date of first use of excluded medication
noncmpdt Date Recommended Date non compliance with protocol medication began
reqdt Date Recommended Date contact requested or due
cntctdt Date Recommended Date of contact
rarefdt Date Recommended Date patient refused ROA
vstdate Date Recommended Visit date
cntctm String 10 Recommended Time of contact
rareftm String 10 Recommended Time patient refused ROA
Query roanot Integer Recommended ROA Not
date_reported Date Recommended Date reported
Query ivr_err Float Recommended IVR error
Query daysrz Integer Recommended days since randomization
Query visit String 60 Recommended Visit name o3week, vstdev
Query rcpoff Integer Recommended rcp off protocol category 1;2 1=Lost to RCP timepoint; 2=Protocol violation
Query whymissd Integer Recommended reason missed timepoint 1::6 1=Patient out of town; 2=Patient could not be located; 3=Patient could not be scheduled due to other commitments; 4=Patient too ill; 5=Hospitalization; 6=Other
Query speclost String 250 Recommended Spec lost
Query pv21days Integer Recommended protocol violation 21 days 0;1;-7 0=No; 1=Yes; -7=Refused
Query pv28days Integer Recommended protocol violation 28 days 0;1;-7 0=No; 1=Yes; -7=Refused
Query pvmissed Integer Recommended proto viol missed assessments 0;1;-7 0=No; 1=Yes; -7=Refused
Query dqmissed Integer Recommended dietary questionairre missing 0;1;-7 0=No; 1=Yes; -7=Refused
Query mhumiss Integer Recommended menstrual history update miss 0;1;-7 0=No; 1=Yes; -7=Refused
Query cmfmiss Integer Recommended CMF missing 0;1;-7 0=No; 1=Yes; -7=Refused
Query ymrs Integer Recommended YMRS missing 0;1;-7 0=No; 1=Yes; -7=Refused
Query madrsmis Integer Recommended MADRS missing 0;1;-7; -9999 0=No; 1=Yes; -7=Refused; -9999=NK/NA/Missing
Query labmiss Integer Recommended lab form missed 0;1;-7 0=No; 1=Yes; -7=Refused
Query tpnmiss Integer Recommended therarpy prog note missed 0;1;-7 0=No; 1=Yes; -7=Refused
Query pvout Integer Recommended protocol violation out of town 0;1;-7 0=No; 1=Yes; -7=Refused
Query pvnloc Integer Recommended protocol violation not located 0;1;-7 0=No; 1=Yes; -7=Refused
Query pvnsch Integer Recommended protocol violation not schedul 0;1;-7 0=No; 1=Yes; -7=Refused
Query pvtooill Integer Recommended protocol violation too ill 0;1;-7 0=No; 1=Yes; -7=Refused
Query pvhosp Integer Recommended protocol violation hospital 0;1;-7 0=No; 1=Yes; -7=Refused
Query pvoth Integer Recommended protocol violation other 0;1;-7 0=No; 1=Yes; -7=Refused other_prot
Query incmasmt Integer Recommended patient unwill unable complete assessments 0;1;-7 0=No; 1=Yes; -7=Refused unable
Query noreturn Integer Recommended pt assessments not returned 0;1;-7 0=No; 1=Yes; -7=Refused notretrn
Query incmpcra Integer Recommended clinician rated incomplete 0;1;-7 0=No; 1=Yes; -7=Refused
Query noattend Integer Recommended pt did not attend sched eval 0;1;-7 0=No; 1=Yes; -7=Refused miss_vis
Query incdthos Integer Recommended assessments incompl dt hosp 0;1;-7 0=No; 1=Yes; -7=Refused
Query late Integer Recommended assessments after halfway pt 0;1;-7 0=No; 1=Yes; -7=Refused
Query othmiss Integer Recommended other reason assessment missed 0;1;-7 0=No; 1=Yes; -7=Refused missoth
Query site String 101 Recommended Site Study Site site_id, site_uid, siteid
Query certcode Integer Recommended stepbd certification code
session_id String 20 Recommended session ID/screening ID screeningid
version_form String 121 Recommended Form used/assessment name form_name
Query pdevid Integer Recommended Deviation number
pdevdtds Date Recommended Date Deviation Discovered
pdevdt Date Recommended Date Deviation Occurred
pdevvsto String 30 Recommended Other visit
Query pdevsev Integer Recommended Deviation Severity 1;2 1=Minor; 2=Major
Query pdevtyp Integer Recommended Deviation Type 1::10 1. Eligibility deviation; 2. Informed Consent Violation; 3. Study drug not taken/dispensed per protocol; 4. Concomitant medication restriction violated; 5. Study procedure violated; 6. Visit deviation; 7. Safety; 8. Safety Labs deviation; 9. IRB Procedures; 10. Other
Query pdevelig Integer Recommended Eligibility Deviation 11 11=1a. Enrollment of a subject who did not meet inclusion or exclusion criteria
Query pdevic Integer Recommended Informed Consent 21::25 21=2a. No documentation of informed consent;22=2b. Informed consent obtained after initiation of procedures;23=2c. Informed consent obtained by someone other than authorized individuals; 24=2d. Missing/Inappropriate documentation of informed consent; 25=2e. Subject signed expired or incorrect version of the consent form
Query pdevsdrg Integer Recommended Study Drug not per protocol 31;32 31=3a. Dosing compliance; 32=3b. Dispensing error
Query pdevcmed Integer Recommended Concomitant Medications 41;42 41=4a. Patient started exclusionary medication during the study; 42=4b. Required supplemental medication discontinued or interrupted during the study per protocol
Query pdevproc Integer Recommended Study Procedure 51::56 51=5a. Study procedure performed that is not approved by the IRB and/or is not in the protocol; 52=5b. Study procedure not performed or not performed properly that in the opinion of the Site Investigator, may affect subject safety or data integrity; 53=5c. Study test/scale not performed or not performed properly that in the opinion of the Site Investigator, may affect subject safety or data integrity; 54=5d. Study procedure not performed or not performed properly that in the opinion of the Site Investigator, does not affect subject safety or data integrity; 55=5e. Study test/scale not performed or not performed properly that in the opinion of the Site Investigator, does not affect subject safety or data integrity; 56=5f. Study procedure conducted out of sequence
Query pdevvst Integer Recommended Visit deviation 61::63 61=6a. Visit not done; 62=6b. Study visit conducted outside of required timeframe that, in the opinion of the PI, may affect subject safety; 63=6c. Visit done out of window
Query pdevsft Integer Recommended Safety 71::73 71=7a. Failure to implement changes necessary to eliminate apparent immediate hazards to the subject; 72=7b. Failure to report serious adverse event (SAE) per protocol to the IRB or Coordination Center; 73=7c. Failure to follow safety (AE) management plan
Query pdevslb Integer Recommended Other deviation 81; 82 81=8a. Missing lab results; 82=8b. Missing Biomarker or Genetics Collection
Query pdevirb Integer Recommended IRB Deviation 91::94 91=9a. Implementation of unapproved recruitment procedures; 92=9b. Over-enrollment; 93=9c. Enrollment of subjects after IRB approval of the study has expired; 94=9d. Failure to submit a continuing review application to the IRB before study expiration
pdevcapa String 1,200 Recommended Description of Corrective Action
Query q1_14a1 Integer Recommended Medication Code 1 1 :: 2099 medcode
Query q1_14b1 Integer Recommended Medication Code 2 1 :: 2099 medcode_2
Query prtclwin Integer Recommended Visit took place outside of protocol window 0;1 0=No;1=Yes
Query uncert Integer Recommended Uncertified Rater 0;1 0=No;1=Yes
Query rateathf Integer Recommended Uncertified-ATHF/ATF 0;1 0=No;1=Yes
Query rateham Integer Recommended Uncertified- HAM 0;1 0=No;1=Yes
Query ratepsr Integer Recommended Uncertified- LIFE/PSR 0;1 0=No;1=Yes; (Note: PSR (Follow-up LIFE);Although the LIFE RIFT(LR) is administered by a rater, there is no certification necessary for the REVAMP LR. )
Query ratescid Integer Recommended Uncertified-SCID/FSCID 0;1 0=No;1=Yes
Query preg Integer Recommended patient become pregnant 0;1;-7 0=No; 1=Yes; -7=Refused
duedate String 30 Recommended Due date duedt
Query phase_discont Integer Recommended Phase of violation phase_i
Query form_ham Integer Recommended HAM form 0;1 0=No;1=Yes ham
Query form_ivc Integer Recommended IVC Form 0;1 0=No;1=Yes ivs
Query form_ml Integer Recommended ML Form 0;1 0=No;1=Yes ml
Query form_pe Integer Recommended PE form 0;1 0=No;1=Yes pe
Query form_po Integer Recommended PO form 0;1 0=No;1=Yes po
Query form_ased Integer Recommended ASED form 0;1 0=No;1=Yes asex
Query form_athf Integer Recommended ATHF form 0;1 0=No;1=Yes athf
Query form_das Integer Recommended DAS form 0;1 0=No;1=Yes das
Query form_deq Integer Recommended DEQ form 0;1 0=No;1=Yes deq
Query form_ewps Integer Recommended EWPS form 0;1 0=No;1=Yes ewps
Query form_fad Integer Recommended FAD form 0;1 0=No;1=Yes fad
Query form_idsc Integer Recommended IDSC form 0;1 0=No;1=Yes idsc
Query form_isr Integer Recommended ISR form 0;1 0=No;1=Yes idssr
Query form_lr Integer Recommended LR form 0;1 0=No;1=Yes lr
Query form_masq Integer Recommended MASQ form 0;1 0=No;1=Yes masq
Query form_mops Integer Recommended MOPS form 0;1 0=No;1=Yes mops
Query form_pabs Integer Recommended PABS form 0;1 0=No;1=Yes pabs
Query form_qmi Integer Recommended QMI form 0;1 0=No;1=Yes qmi
Query form_sas Integer Recommended SAS form 0;1 0=No;1=Yes sas
Query form_scid Integer Recommended SCID form 0;1 0=No;1=Yes scid
Query form_fscid Integer Recommended FSCID form 0;1 0=No;1=Yes fscid
Query form_sp36 Integer Recommended SF36 form 0;1 0=No;1=Yes sf36
Query form_spsi Integer Recommended SPSI form 0;1 0=No;1=Yes spsi
Query form_teq1 Integer Recommended TEQ1 form 0;1 0=No;1=Yes teq1
Query form_teq2 Integer Recommended TEQ2 form 0;1 0=No;1=Yes teq2
Query form_waic Integer Recommended WAIC form 0;1 0=No;1=Yes waic
Query form_wait Integer Recommended WAIT form 0;1 0=No;1=Yes wait
Query form_bpt Integer Recommended BPT Form 0;1 0=No;1=Yes bpt
Query form_psr Integer Recommended PSR Form 0;1 0=No;1=Yes psr
Query rtda3 Integer Recommended Was study treatment discontinued for administrative reasons? 0;1 1=Yes; 0=No;Note: This implies that both the patient and the clinical staff judge the assigned antipsychotic treatment to be a success (i.e. adequately effective, with tolerable or no side effects), and that treatment would have continued if not for the administrative reason independent of the study procedures. admin
Query noncmpdt1 Integer Recommended Date of non-compliance (in days) daydev
Query visday Integer Recommended Number of days from study baseline to date of visit date1, date_form
Query phase Integer Recommended Phase 9 =follow up
Query med2b Integer Recommended Visit Day Number of days from study baseline to date of visit
Query scidrevw Integer Recommended SCID review 1 1=Yes
Query ad_inc1 Integer Recommended Clinical diagnosis of Dementia of the Alzheimers Type (DSM-IV) or NINCDS/ ADRDA criteria for possible or probable Alzheimers disease (McKhann et al., 1984). 0;1 0=No; 1=Yes
Query ad_inc2 Integer Recommended Outpatient living at home, in residential care, or assisted living (not nursing home). 0;1 0=No; 1=Yes
Query ad_inc3 Integer Recommended Ambulatory, able to ambulate independently or with a cane or 4-point walker, but not bed- or wheelchair- bound. 0;1 0=No; 1=Yes
Query ad_inc4 Integer Recommended MMSE score between 5 and 26 inclusive 0;1 0=No; 1=Yes
Query ad_inc5 Integer Recommended Presence of delusions, hallucinations, or agitation/aggression, severe enough to disrupt the patients functioning, and severe enough, in the opinion of the investigator, to justify medication treatment. 0;1 0=No; 1=Yes
Query ad_inc6 Integer Recommended The delusions, hallucinations, or agitation/aggression have occurred nearly everyday over the previous week, or at least intermittently over 4 weeks 0;1 0=No; 1=Yes
Query ad_inc7 Integer Recommended A score of moderate or higher (score of ? 3) on any one of the following BPRS items: 0;1 0=No; 1=Yes
Query ad_inc8 Integer Recommended Onset of the psychotic or agitation/aggression must have been after the onset of cognitive and functional signs or symptoms of dementia. 0;1 0=No; 1=Yes
Query ad_inc9 Integer Recommended Must have an informant who lives with, or visits the patient at least 8 hours per week over at least 3-4 days per week. 0;1 0=No; 1=Yes
Query ad_inc10 Integer Recommended Informed consent from patient and legal representative, or assent from the patient and informed consent from the representative according to relevant state laws 0;1 0=No; 1=Yes
Query ad_inc11 Integer Recommended The results of laboratory screening studies (see below) are not inconsistent with a psychosis of Alzheimers disease or agitation not due to a medical cause. 0;1 0=No; 1=Yes
Query ad_exc1 Integer Recommended Receiving and benefiting from psychotropic medication treatment 0;1 0=No; 1=Yes
Query ad_exc2 Integer Recommended Fulfills criteria for schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features 0;1 0=No; 1=Yes
Query ad_exc3 Integer Recommended Fulfills criteria for delirium 0;1 0=No; 1=Yes
Query ad_exc4 Integer Recommended Has a psychosis, agitation, or aggression that could be better accounted for by another general medical condition or direct physiological effects of a substance 0;1 0=No; 1=Yes
Query ad_exc5 Integer Recommended Fulfills criteria for probable vascular dementia (AIRENS-NINDS criteria) 0;1 0=No; 1=Yes
Query ad_exc6 Integer Recommended Fulfills criteria for Lewy body variant of AD (McKeith criteria) 0;1 0=No; 1=Yes
Query ad_exc7 Integer Recommended Severe or unstable medical illness treatment 0;1 0=No; 1=Yes
Query ad_exc8 Integer Recommended In need of psychiatric admission in judgment of study site or local physicians 0;1 0=No; 1=Yes
Query ad_exc9 Integer Recommended Acutely suicidal or has persistent suicidal intent 0;1 0=No; 1=Yes
Query ad_exc10 Integer Recommended Previous or current treatment with any two of the three atypical antipsychotic study medications or with citalopram 0;1 0=No; 1=Yes
Query ad_exc11 Integer Recommended Current use of antidepressants or anticonvulsants 0;1 0=No; 1=Yes
Query ad_exc12 Integer Recommended Current plans to start a cholinesterase inhibitor or antidepressant medication during the subsequent 24 weeks ( patient may be currently receiving stable doses of a cholinesterase inhibitor) 0;1 0=No; 1=Yes
Query ad_exc13 Integer Recommended Hypersensitivity or absolute contraindications to any of the study medications 0;1 0=No; 1=Yes
Query unbl_p1 Integer Recommended Phase 1 blind broken - doing well at com 1 1=patients who were unblinded after successful completion of the phase
Query unbl_p2 Integer Recommended Phase 2 blind broken - doing well at com 1 1= patients who were unblinded after successful completion of the phase
Query timept Integer Recommended Time Point 888 = not applicable; 999 = missing
Query daywaiver Integer Recommended Study Day of Waiver
Query dayasmnt Integer Recommended Study Day of Assessment
Query deviation Integer Recommended Deviation Category 1::12 1= Ineligible subject enrolled;2= Concomitant use of excluded medication;3 = Concomitant use of excluded psycho-social treatment;4 = Assessment completed outside of protocol-designed window;5 = Assessment not completed;6 = Dosage outside of prescribed dosing schedule;7 = Inclusion / exclusion criterion waived;8 = Other; 9 = Safety issues; 10 = Consent issues; 11 = Enrollment issues; 12 = Protocol implementation issues
devconrx String 60 Recommended Specify Excluded Medication
Query devcontx Integer Recommended Specify Excluded Psycho-social Treatment
devvisit String 50 Recommended Details of Out-of-Window Assessment
Query devdays Integer Recommended Days Out-Of-Window
devvisitreason String 50 Recommended Why was Assessment Out-Of-Window?
Query window Integer Recommended Which assessment window was violated -1 = Gate B to Gate C1 (28 days);0 = Gate C1 to Gate C2 (7 days);12 = Assessment 12 (+/- 5 days);24 = Assessment 24 (+/- 10 days);36 = Assessment 36 (+/- 10 days)
devmav String 50 Recommended Reason Assessment was Missed
devmavcode String 100 Recommended Coded Reason for Missed Assessment
Query assesmnt Integer Recommended Which Assessment was Not Completed? 0;4;8;12;24;36 0 = Gate C1 to Gate C2;4 = Week 4;8 = Week 8;12 = Week 12;24 = Week 24;36 = Week 36
devdosag String 50 Recommended Describe Dosing Deviation
devdosagetype String 50 Recommended Type of Dosage Deviation
devinex String 50 Recommended Specify criterion waived
Query waiver Integer Recommended Patient did not meet all eligibility requirements but a waiver was granted during the caseness panel review 0;1 0 = No 1 = Yes
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 phnphn String 10 Recommended Two consecutive phone visits yes; no
Query rand_med String 10 Recommended Given med other than random assignment yes; no
Query origarm String 30 Recommended Assigned med bup+blue; ven+green; escit+orange
Query givenarm String 30 Recommended Med given bup+blue; ven+green; escit+orange
Query nochron String 10 Recommended No Chronic Depression at Baseline yes; no
missedform String 250 Recommended Missed Form form
missedvisit String 10 Recommended Missed visit
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) dateterm
date_updated Date Recommended Date record updated edit_date
Query pdevnone Integer Recommended No deviations occurred for this subject 1=Checked
Query violationtype Integer Recommended Type of violation 1::14 1 = Blind broken during trial to masked member of research team;2 = (Medication non-adherence: only applies if patient intends to stay in the study) Patient took less than 80% of prescribed medication during course of treatment;3 = (Medication non-adherence: as above) Patient has been off study medication longer than one week;4 = Patient took excluded medication during course of study;5 = Randomized patient did not meet study criteria;6 = Laboratory values for randomized patient were outside accepted parameters without documented justification;7 = Screening labs not completed (exception may be toxicology screens when subject has been inpatient for > 1 week);8 = Consent not signed;9 = Capacity not evaluated, or incorrectly evaluated;10=If in Lithium arm, discontinued Lithium; 11= If in OPT arm, started Lithium; 12= Medication recommendations by a non-LiTMUS physician; 13= Missed two consecutive study visits; 14= Other
Query violationdays Integer Recommended Days from baseline violation occurred
Query study_id Integer Recommended Study ID number 46=Acute Phase; 47=Stabilization Phase
Query viol String 30 Recommended Primary reason for the participant's protocol violation/deviation Early discont.; LLA; LVT; Non-Adherent; Rand. Err; Visit window; Sub Lack effic; Sub Side eff; Clin Lack effic; Clin Side eff; Treat site; Unwill proc; Unable cont; Interv ill; Other Early discont.=Early treatment discontinuation; LLA=Start/stop/change LLA; LVT=Start/stop/change LVT ; Non-Adherent=Was not at least 50% adherent with taking study meds over the 5 months of follow-up (V7 ? V11) AND at least 50% adherent with taking study medsover the last month of the study (V11) ; Rand. Err=Randomization error ; Visit window=Outside visit window; Sub Lack effic=Subject's decision: Lack of efficacy of study medication; Sub Side eff=Subject's decision: Side effects of study medication; Clin Lack effic=Clinician's decision: Lack of efficacy of study medication; Clin Side eff=Clinician's decision: Side effects of study medication; Treat site=No longer wants to be treated at study site (or seeking treatment elsewhere); Unwill proc=Unwilling/unable to comply with study procedures; Unable cont=Unable to be contacted/schedule a follow-up; Interv ill=Intervening medical illness that precludes continued participaation in the study
Query op_2 Integer Recommended Last study visit number the subject was still on protocol 0;2;4;6;8;12;16;20;24 0=Baseline; 2=Week2; 4=Week4; 6=Week6; 8=Week8; 12=Week12; 16=Week16; 20=Week20; 24=Week24
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 op_stop Integer Recommended Days from date of subject went back on protocol to baseline visit date
Query signspt Integer Recommended Are there clinically significant Complaints or Signs Present? 0;1 Yes=1; No=0
Query exgrant Integer Recommended If protocol violation, was an exception granted? (Was patient allowed to continue with the study?) 0;1 0 = No; 1 = Yes
Query pv_irboff Integer Recommended Offset from randomization of IRB notification
Query rand_num Integer Recommended Randomization Number 0::2
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 lineno Integer Recommended Line number (lines per participant) 0::150
Query irbrprt Integer Recommended Report to IRB 1;2 1=Yes; 2=Doesn't fit criteria for IRB reporting
irbrptdt Date Recommended IRB report date
Query iecsig Integer Recommended Investigator signature on form. 0;1 0=No; 1= Yes
Query sigd1 Integer Recommended Physician/PI signature date (days since randomization)
Query pdcode Integer Recommended Deviation code number 1::26 1. Not reporting a serious complication within 24 hours; 2. Appropriate labs not obtained for individuals on anticonvulsants; 3. Pregnancy test not performed for female of childbearing potential; 4. Reportable safety events not reported to IRB; 5. Abnormal lab values at entry not reviewed by Steering Committee; 7. Failure to obtain informed consent; 8. Consent form used was not current IRB-approved version; 9. Consent form does not include updates or information required by IRB; 10. Consent form missing; 11. Consent form not signed and dated by subject parent/guardian; 12. Consent form does not contain all required signatures; 13. Videotape consent not obtained prior to Baseline Visit; 15. Randomization of an ineligible child; 16. Subject is randomized prior to Baseline Diagnosis, Baseline Assessment, etc.; 17. Randomization and/or treatment of subject prior to IRB approval; 19. Failure to keep IRB approval up to date; 20. Subject receives wrong treatment; 21. Subject seen outside window of normal follow-up visits; 22. Subject did not meet response criteria but continued in study; 23. Use of unallowable concomitant treatments; 24. Prescribed dosing outside protocol guidelines; 25. Patient exceeded allowable weight gain and not exited from study; 26. Other, specify in table
scapv01 Date Recommended Date of Deviation (DD/MM/YYYY)
scapv02 Integer Recommended Protocol Violation/Deviation Visit 0::6 0=Screening ; 1=Baseline; 2=6 months; 3=Year 2; 4=Year 3; 5=Year 4; 6=Year 5
scapv03 Integer Recommended Date Deviation was Identified(DD/MM/YYYY
scapv04 Integer Recommended Deviation Type: 0::6 0=Informed Consent; 1=Eligibility criteria; 2=Laboratory Assesments/Procedures; 3=Study Procedures; 4=Serious Adverse Event Reporting; 5=Visit Schedule/Interval; 6=Other
scapv05 String 150 Recommended Deviation Type: If other please describe
scapv06 String 250 Recommended Brief description of violation/deviation identified above:
scapv07 Integer Recommended Meets International Review Board(IRB) reporting Requirements? 0;1 0=No; 1=Yes
scapv08 Date Recommended If yes, International Review Boardf(IRB) Reporting Date: (DD/MM/YYYY)
scapv09 String 250 Recommended Action taken by the International Review Board(IRB): if any
deviation_age Integer Recommended AGE IN MONTHS AT PROTOCOL DEVIATION
devidentified_age Integer Recommended AGE IN MONTHS WHEN DEVIATION IDENTIFIED
pinotified_age Integer Recommended AGE IN MONTHS WHEN PI NOTIFIED
irbnotified_age Integer Recommended AGE IN MONTHS WHEN IRB NOTIFIED
scapv02_a Integer Recommended Protocol Violation/Deviation Visit: Clinic/MR 1;2 1=Clinic; 2=MR
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)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

At the top of this page you can also:

  • Use the search bar to filter the elements displayed. This will not filter on the Size of Required columns
  • Download a copy of this definition in CSV format
  • Download a blank CSV submission template prepopulated with the correct structure header rows ready to fill with subject records and upload

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