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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

End of Phase Form

2,628 Shared Subjects

Clinical Trials: End of Phase Form
Clinical Assessments
Exit Form
05/07/2014
endphase01
12/16/2022
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
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.
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
Query visitid Integer Recommended MetaTrial Visit ID System variable: unique code for each type of visit -use to merge files
Query visit String 60 Recommended Visit name
Query truncvis Integer Recommended Truncated Visit Number Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
Query phase_ct String 20 Recommended Current 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
Query visday Integer Recommended Number of days from study baseline to date of visit
protocol String 50 Recommended Protocol [Study] name
Query rtd01 Integer Recommended Day of phase discontinuation Number of days from study baseline to date of phase discontinuation dayeop12, dayeop36
Query rtd02 Integer Recommended Did pt successfully complete the medication 0;1 0=No; 1=Yes, Skip to Section IV
Query rtd03 Integer Recommended I.1 Administrative Discontinuation - Wer 0;1 0=No;1= Yes eop03
Query rtd04 Integer Recommended II. Clinical Discontinuation 0;1 0=No;1= Yes eop04
Query rtd05a Integer Recommended Inadequate therapeutic effect 1;0 1=yes; 0=no
Query rtd05b Integer Recommended Please choose 1;2 1=Primary; 2=Secondary
Query rtd05c Integer Recommended The problematc psychopatholgy was primarily 1::4 1=Positive; 2=Negative; 3=Affective; 4=Other reason, specify
Query rtd06a Integer Recommended Unacceptable side effects 0;1 0=No;1= Yes
Query rtd06b Integer Recommended Please choose 1;2 1=Primary; 2=Secondary
Query rtd06c Integer Recommended The most problematic side effect was 1::4 1=Extrapyramidal; 2=Weight/Metabolic; 3=Sexual; 4=Other reason, specify
Query rtd07a Integer Recommended Refusal/failure to take assigned antipsychotics 0;1 0=No;1= Yes
Query rtd07c Integer Recommended Is patient agereable with taking diffrent antipsychotics? 0;1 0=No;1= Yes
Query rtd08 Integer Recommended Patient withdrawn by subject advocate 0;1 0=No;1= Yes
Query rtd09 Integer Recommended Is the pt proceeding to the next medicat 0;1 0=No;1= Yes
Query rtd10 Integer Recommended Did a substance use disorder contribute 0;1 0=No;1= Yes
Query rtd11 Integer Recommended CLINICIAN: Which medication do you think was used 1::5;95;99 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 95=Refused to guess; 99=N/A On open-label Clozapine
Query rtd12 Integer Recommended pt: Which medication do you think you were taken 1::5;95;99 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 95=Refused to guess; 99=N/A On open-label Clozapine
Query rtd13 Integer Recommended Investigator signed end of phase source document 0;1 0=No;1= Yes
Query rtd14 Integer Recommended Investigator faxed end of phase source document 0;1 0=No;1= Yes
Query eop01 Integer Recommended What phase is the patient being discontinued from? 1;2;3;4 1=1; 2=2; 3=3; 4=Open Choice fhx10a
Query eop02a Integer Recommended Did the patient complete the full 36 weeks of study? 0;1 0=No; 1=Yes fhx10b
Query eop04a Integer Recommended Clinical Discontinuation: If yes, please state the reason 1;2;3;4;5 1 = a. Inadequate therapeutic effect; 2 = b. Study drug was not sufficiently optim; 3 = c. Worsening of symptoms; 4 = d. Unacceptable side effects';' 5 = e. Study drug is no longer needed
Query eop04b Integer Recommended II. Clinical Discontinuation: The most problematic side effect was: 1;2;3;4;5;6;7 1 = Extrapyramidal; 2 = Weight gain; 3 = Weight loss; 4 = Falling; 5 = Syncope/dizziness/vertigo; 6 = Confusion; 7 = Other reason
Query eop05 Integer Recommended Refusal/failure to take the assigned study drug 0;1 0=No; 1=Yes
Query eop05b Integer Recommended Patient Decision: Is the patient agreeable with taking a different study drug? 0;1 0=No; 1=Yes
Query eop06 Integer Recommended Caregiver's decision 0;1 0=No; 1=Yes
Query eop06b Integer Recommended Caregiver's Decision: Is the caregiver agreeable with the patient taking a different study drug? 0;1 0=No; 1=Yes
Query eop07 Integer Recommended Patient died during this study phase 0;1 0=No; 1=Yes
Query eop08 Integer Recommended What is the course of action for the patient? 1;2;3 1 = Move to next randomized phase; 2 = Move to open-choice phase; 3 = Discontinued from the study*
Query eop08a Integer Recommended Course of Action: What randomized phase proceeding to? 2;3 2=2; 3=3
Query eop09 Integer Recommended Has the investigator signed the End of Phase source document? 0;1 0=No; 1=Yes
Query eop02 Integer Recommended Day of phase discontinuation Number of days from study baseline to date of phase discontinuation
Query eop10 Integer Recommended Investigators Signature Day signed: Number of days from study baseline to date investigator's signature was obtained
Query eop07a Integer Recommended Patient Death: Day of patient death Number of days from study baseline to date of death
Query daylast1vst Integer Recommended study day of last TREATMENT visit daylast2vst
Query complet1 Integer Recommended Did this child complete Phase TREATMENT PORTION of the study? 0;1 0 = no; 1 = yes complet2
Query y1notdun Integer Recommended Which one of the following explains why the subject did not complete Phase 1::4 1 = Study dropout; 2 = Treatment dropout; 3 = Premature termination; 4 = Other reason y2notdun, y2notdun_d
Query lastp1wk Integer Recommended Week of last TREATMENT visit lastp2wk
Query camsresponse Integer Recommended TREATMENT RESPONSE from End of Phase Form 1;2;3;4 1 = Active Treatment Responder;2 = Active Treatment Non-responder;3 = Placebo Responder;4 = Placebo Non-responder
Query actvresp Integer Recommended Active Treatment responder: Does family agree to continue in maintenance treatment? 0;1 0 = no; 1 = yes
Query nomaintx String 50 Recommended Active Treatment responder: Explain no maintenance treatment
Query actvnonr Integer Recommended Active Treatment non-responder: Does family agree to community referral? 0;1 0 = no; 1 = yes
Query nocomref String 50 Recommended Active Treatment non-responder: Explain no community referral
Query pboresp Integer Recommended Placebo responder: Does family agrees to monthly maintenance visits and IE assessments? 0;1 0 = no; 1 = yes
nostoptx String 50 Recommended Placebo responder: Explain no maintenance and IE assessments
Query openlabl Integer Recommended Placebo non-responder: Does family agree to Open-label CAMS Treatment? 0;1 0 = no; 1 = yes
Query treatment_name String 200 Recommended treatment name
Query noopnlbl String 50 Recommended Placebo non-responder: Explain no Open Label
Query faz1done Integer Recommended Did child complete Phase Assessments? 0;1 0 = no; 1 = yes faz2done
Query completed Integer Recommended Checks if completed 0::3 0=No; 1=Yes; 2=Yes, lost; 3=Unverified wk4
Query wkasscomp Integer Recommended Study Week Assessment Completed
Query faz2asmt Integer Recommended Does the family agree to continue with Phase II Assessments? 0;1 0 = no; 1 = yes
comments_misc String 4,000 Recommended Miscellaneous comments on study, interview, methodology relevant to this form data ynofaz2
Query discontinuation_reason1 String 250 Recommended Discontinuation Reason: otheresn
Query otheresn_d Integer Recommended Other Reason Derived 1::5 1::5
Query final_r_pd Integer Recommended Remission Psychotic Depression: Remission was defined as a HAM-D 17 item score of 10 or lower at 2 consecutive assessments. Remission also required the absence of delusions (SADS delusional item score of 1) at the second remission of depression assessment. Subjects who were not delusional at both of 2 consecutive HAM-D assessments were considered remitted at both points; subjects who had been delusional at the first of the HAM-D assessments were considered to be remitted at the second assessment only, and subjects who were not delusional at the first assessment but had SADS scores higher than 1 at the second were classified as not remitted at either assessment. Subjects who achieved a HAM-D score of 10 or lower without delusions for the first time at week 12 were assessed again at week 13 to determine whether the 2-week duration criterion was met. 0;1 0 = no; 1 = yes
Query lastvisit Integer Recommended This 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;1 0 = no; 1 = yes
Query outcome_text String 100 Recommended Outcome Text
Query outcome_id Integer Recommended Outcome Code 2::42 2 = Dropped Medical Reasons - Side Effects; 3 = Dropped Medical Reasons - Inter-current Events; 7 = No Longer Meets Study Criteria; 14 = Completed Study; 20 = Other; 21 = Death - non-suicide; 22 = Suicide attempt or increased suicidality; 23 = Worsening depression; 24 = Lost to follow-up; 25 = Patient moved - distance; 26 = Worsening psychosis; 27 = Worsening depression and psychosis; 28 = Other emergent psychiatric symptoms; 29 = Patient Perception: Clinical improvement; 30 = Completed suicide attempt; 34 = Patient perception: Ineffective treatment; 35 = Patient changed mind about participation in research; 36 = Patient's family opposed to his/her study participation; 37 = Patient refused further study med treatment (not due to side effects); 38 = Problems with transportation; 39 = Protocol violation; 41 = Inappropriate for research participation; 42 = Insufficient therapeutic response
Query outcomedays Integer Recommended Outcome Days from Baseline
Query statusa Integer Recommended What was the outcome of the Acute Phase? 1::3 1 = Met Full Remission criteria; 2 = Met Partial Remission criteria; 3 = Non-remitted; 4 = Randomized then exited
Query stabyesno Integer Recommended For Partial and Full Remitters at 12 weeks: Will patient enter Stabilization Phase? 0;1 0 = no; 1 = yes
Query nostabexplain String 500 Recommended Explain not going into Stabilization
Query study_id Integer Recommended Study ID number 46=Acute Phase; 47=Stabilization Phase
Query inttimewk Integer Recommended Week of study: Initial -2 = pre-baseline (2 weeks); -1 = pre-baseline (1 week); 0 = baseline; 1 = week 1; 12 = week 12; 13 = week 13; 14 = week 14
Query week Float Recommended Week in level/study 99=week 10-week 14 intid
Query site String 101 Recommended Site Study Site
Query statuss Integer Recommended What was the outcome of the Stabilization Phase? 1::4 1 = Met Full Remission criteria; 2 = Met Partial Remission criteria; 3 = Relapse; 4 = Significant Clinical Worsening
Query responsible Integer Recommended If outcome is Early Termination, who was the primary person responsible for the early termination? 1::5 1 = Patient; 2 = Study Investigator; 3 = Physician at institution- not involved in study; 4 = Physician outside institution (e.g., Primary care physician); 5 = Family member or significant other
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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