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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Clinical Trials: Randomization

2,647 Shared Subjects

Clinical Trials: Randomization
Clinical Assessments
Summary
06/26/2014
rdm01
01/09/2020
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* guid
src_subject_id String 20 Required Subject ID how it's defined in lab/project SUBJECT, bid, id, randid, record_id, rsubjid, subject_id
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY RVDATE, date_of_interview_contact, intvdate
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. age, dema1, intvage
sex String 20 Required Sex of subject at birth
M;F; O; NR
M = Male; F = Female; O=Other; NR = Not reported dema2, gender, sex
Query aescode Integer Recommended Staff code number of person completing this form 999= Missing Data RDMCODE, interviewer_code
Query visit String 60 Recommended Visit name int1, redcap_event_name
Query bafinfo Integer Recommended Check if the Assessment was not done. 0::2 0=No; 1=Yes; 2=Unverified RDMINFO
Query mtinc Integer Recommended Does the subject continue to meet the inclusion exclusion criteria? 0;1; -9 0=No; 1=Yes; -9=unknown ran001
Query elrdm Integer Recommended Is the subject eligible for randomization? rdma3
rdmdate Date Recommended Date of Randomization ran003, rand_local_date
prjdate6 Date Recommended 6 week projection date
prjdate12 Date Recommended 12 week projection date
Query hlocondition Integer Recommended What condition is the patient randomized to? 0;1 0=Control; 1=Posit Science CONDITION
Query nrdmrsn Integer Recommended Primary reason not randomized 0::5 1=Failed to meet inclusion criteria; 2=Withdrew consent; 3=Medical reason (AE, illness, etc); 4=Non-compliance with protocol treatment; 5=Subject requires prohibited medication; 0=Other ran005
nrdmspc String 500 Recommended Specify other reason not randomized ran006
site String 101 Recommended Site Study Site siteid
Query ran001a Integer Recommended Was this subject a re-screen? 0;1 0=No; 1=Yes
Query ran001b Integer Recommended Were all re-screen assessments performed? 0;1 0=No; 1=Yes
Query ran002 Integer Recommended Was the subject randomized? 0::3; -9 0=No; 1=Yes; -9=unknown; 2=No meds; 3=No community care ran_q1b
ran004 String 10 Recommended Randomization number/coding cohort
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 rdma1 Integer Recommended Does the patient still give consent to participate in the study? 0;1 0=No; 1=Yes
Query rdma2 Integer Recommended Is the patient still considered eligible for study participation? 0;1 0=No; 1=Yes
Query rdma4 Integer Recommended Do you want to randomize this patient? 0;1 0=No; 1=Yes
Query rdma6 Integer Recommended Do you need a bottle code for the oral trial? 0;1 0=No; 1=Yes
Query version String 20 Recommended Version/code of assessment
Query visday Integer Recommended Number of days from study baseline to date of visit
version_form String 121 Recommended Form used/assessment name
Query daysrz Integer Recommended days since randomization date, visitdt
study String 100 Recommended Study; The code for each individual study studyid
Query completed Integer Recommended Checks if completed 0::3 0=No; 1=Yes; 2=Yes, lost; 3=Unverified formcomp
Query subtrial_name Integer Recommended Name of subtrial 1::3 1=Crossover; 2=Guanfacine; 3= Open Label MPH
Query ran_q1 Integer Recommended Tolerate 4 lowest Doses 0;1 0=No; 1=Yes
Query ran_q1a Integer Recommended Tolerate highest dose 0;1 0=No; 1=Yes
Query ran_q4 Integer Recommended Primary reason not randomized 1::10 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 (current or pending); 7 = Death; 8 = Subject no longer eligible to participate; 9 = School unable/no longer willing to participate; 10 = Other
Query enrl_ord Integer Recommended Order of Enrollment - The first subject enrolled in the Guanfacine Trial (i.e., the earliest enrollment date) has ENRL_ORD = 1, the second subject enrolled has ENRL_ORD = 2, the third has ENRL_ORD = 3, etc. Subjects enrolled on the same day are given the same number. Derived variable, not on CRF
Query ranq5 Integer Recommended Reason not randomized 1::7;-9 1=Failed to meet inclusion or exclusion criteria; 2=Declined study participation/Withdrew consent; 3=Failed to return to clinic; 4=Moved from area; 5=Incarceration; 6=Death; 7=Other; -9=Unknown
Query arm Integer Recommended Assigned Randomization Arm 1::3 1=Escitalopram plus Orange capsule-Lexapro; 2=Bupropion-SR plus Blue capsule-Wellbutrin; 3=Venlafaxine XR plus Green capsule-Effexor
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 ran004a Integer Recommended Treatment Group 1;2;-9 1=start treatment with ketamine; 2= start treatment with saline; -9 =unknown q4a
inelgs String 250 Recommended Ineligible reason rdma2a
Query iec16 Integer Recommended Eligibility status 1::3 1=Eligible; 2= Ineligible; 3=Pending rdma3a
Query iec003a Integer Recommended Is the subject eligible to participate in the study?
0;1;-9
0=No; 1=Yes; -9=Unknown rndqual
trtarm String 200 Recommended Treatment arm treatment
datetime String 25 Recommended Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYY and __:__ sitedtm
Query resubmit Integer Recommended Randomization error- resubmit
0;1; -9
0=No; 1=Yes; -9=Unknown
Query ad_exc11 Integer Recommended Current use of antidepressants or anticonvulsants 0;1 0=No; 1=Yes
treatment_name String 200 Recommended treatment name
Query randomization Integer Recommended Randomization Field 2;3 2=Blue; 3=White
Query ca6_1 Integer Recommended Chronic depression 0;1 0=No; 1=Yes
Query bdi_stw Integer Recommended Suicidal thoughts or wishes 0;1;2;3;-7; -9 0=I don't have any thoughts of killing myself; 1= I have thoughts of killing myself, but I would not carry them out; 2=I would like to kill myself; 3=I would kill myself if I had the chance"; -7=Refused; -9=incomplete
psmd1 String 250 Recommended Psych med code 1
refothers String 50 Recommended Referral source: specify
Query med_group Integer Recommended Randomly Assigned Medication Group 0;1 (0=Changed to Second SSRI, 1=Changed to VENLAFAXINE)
Query cbt_group Integer Recommended Randomly Assigned to Clinical Behavior Therapy? 0;1 (0=No, 1=Yes)
ssricat String 50 Recommended Randomly Assigned SSRI
cameon String 50 Recommended Current SSRI
Query noparox Integer Recommended Constrain paroxetine? 1 1 = YES for all patients; YES for all patients became active when study stopped using paroxetine.
Query refflu Integer Recommended Did patient refuse fluoxetine?(Prozac) 0;1 0 = No; 1 = Yes
Query refcit Integer Recommended Did patient refuse citalopram?(Celexa) 0;1 0 = No; 1 = Yes
Query refpar Integer Recommended Did patient refuse paroxetine? 0;1 0 = No; 1 = Yes
Query comanx Integer Recommended COMORBID ANXIETY 0;1 0=No; 1=Yes
Query rnd_5 Integer Recommended Randomized provider number
Query lithever Integer Recommended ever taken lithium 0;1;-7 0=No; 1=Yes; -7=Refused
Query week Float Recommended Week in level/study 99=week 10-week 14
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 iecsig Integer Recommended Investigator signature on form. 0;1 0=No; 1= Yes
lab020 Date Recommended Date of PI/clinician signature
Query sigd1 Integer Recommended Physician/PI signature date (days since randomization)
general_2 String 4,000 Recommended How have you been since I last saw you?
general_3 String 4,000 Recommended Do you have any specific worries or complaints about your health in general?
general_4a Integer Recommended Have you missed taking any of your trial medicines? 0=No; 1=Yes
general_4b Float Recommended Have you missed taking any of your trial medicines? If yes, how many days? 2 decimal place
general_4c String 4,000 Recommended Have you missed taking any of your trial medicines? Any why?
general_5 String 4,000 Recommended Have you had any problems relating to the trial capsules?
general_6 String 4,000 Recommended Do you have any other problems or worries in relation to the trial?
comments_misc String 4,000 Recommended Miscellaneous comments on study, interview, methodology relevant to this form data clinician_notes
rand_treat String 20 Recommended Randomized treatment MST;ECT
rand_call_date Date Recommended Date of telephone call
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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