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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Enrollment Form

5,006 Shared Subjects

N/A
Clinical Assessments
Enrollment
12/23/2014
enrol01
02/14/2024
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 randid, stepid, 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. age
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported comments, gender
Query daysrz Integer Recommended days since randomization studyday, visitdt
Query certcode Integer Recommended stepbd certification code
Query race String 30 Recommended Race of study subject American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White; Other
Query agege15 Integer Recommended current age ge 15 years 0;1;-7 0=No; 1=Yes; -7=Refused
Query inmdd Integer Recommended IN: meets DSM-IV criteria 0;1;-7;-9 0=No; 1=Yes; -9=unknown; -7=refused dsmivcri
Query ptcon Integer Recommended Patient consented
0;1
0=No; 1=Yes cnsnt, consent
Query dschizo Integer Recommended dsm iv criteria shizoaffective 0;1;-7 0=No; 1=Yes; -7=Refused
Query preginfo Integer Recommended inform md of pregnancy 0;1;-7 0=No; 1=Yes; -7=Refused
Query noncompl Integer Recommended unwilling or unable to comply 0;1;-7 0=No; 1=Yes; -7=Refused
Query novisit Integer Recommended unable to attend scp visit 0;1;-7 0=No; 1=Yes; -7=Refused
Query noread Integer Recommended patient cannot read 0;1;-7 0=No; 1=Yes; -7=Refused
Query nowrite Integer Recommended patient cannot write 0;1;-7 0=No; 1=Yes; -7=Refused
Query noenglsh Integer Recommended patient not fluent in english 0;1;-7 0=No; 1=Yes; -7=Refused
Query ncoth Integer Recommended NC: other reason 0;1 0=Not checked; 1=Checked
Query ccwork Integer Recommended patient given coll care wrkbk 0;1;-7 0=No; 1=Yes; -7=Refused
Query ccvideo Integer Recommended patient given coll care video 0;1;-7 0=No; 1=Yes; -7=Refused
Query site String 101 Recommended Site Study Site site_id, site_uid, siteid
Query ethnicity String 30 Recommended Ethnicity of participant
Hispanic or Latino; Not Hispanic or Latino; Unknown
Query study String 100 Recommended Study; The code for each individual study studyid
Query visit String 60 Recommended Visit name int1, interval, visit_name
Query completed Integer Recommended Checks if completed 0::3 0=No; 1=Yes; 2=Yes, lost; 3=Unverified formcomp, frmcomp
Query subtrial_name Integer Recommended Name of subtrial 1::3 1=Crossover; 2=Guanfacine; 3= Open Label MPH
Query ols_q1 Integer Recommended Entering Open Label? 0;1 0=No; 1=Yes enroldate_olstudy
Query ols_q2 Integer Recommended Reason for not entering 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 (Complete Serious Adverse Events Form) 8 = Subject no longer eligible to participate. 9 = School unable/no longer willing to participate 10 = Other enr04b
Query incl01 Integer Recommended Parents provide written consent 0;1 0=No; 1=Yes
Query incl02 Integer Recommended Age 4 years 6 months to 14 years of age inclusive 0;1 0=No; 1=Yes
Query incl03 Integer Recommended Diagnosis of PDD/Aspergers/Autism 0::4 0=No; 1=Yes; 2=Current; 3=In partial remission; 4= Past
Query incl04 Integer Recommended Med free CGI for PDD >= 4 0;1;-7;-9 0=No; 1=Yes; -7=refused; -9=unknown
Query incl05 Integer Recommended Meet parent and teacher SNAP-IV criteria 0;1;-7;-9 0=No; 1=Yes; -7=refused; -9=unknown
Query incl06 Integer Recommended Mental age >= 18 months 0;1 0=No; 1=Yes
Query excl01 Integer Recommended Mental age < 18 months 0;1 0=No; 1=Yes
Query excl02 Integer Recommended DSM diagnosis requiring pharmacotherapy 0;1 0=No; 1=Yes
Query excl03 Integer Recommended Significant medical condition 0;1;-7;-9 0=No; 1=Yes; -7=refused; -9=unknown
Query excl04 Integer Recommended Diastolic BP out of range 0;1 0=No; 1=Yes
Query excl05 Integer Recommended Concurrent treatment with another psychotropic medication within one to three weeks of baseline 0;1 0=No; 1=Yes
Query excl06 Integer Recommended Subject weighs less than 16 kg 0;1;-7;-9 0=No; 1=Yes; -7=refused; -9=unknown
Query excl07 Integer Recommended Hypersensitive to Guanfacine 0;1;-7;-9 0=No; 1=Yes; -7=refused; -9=unknown
Query excl08 Integer Recommended Exclusion criteria exception used for this subject ? 0;1;-7;-9 0=No; 1=Yes; -7=refused; -9=unknown
Query enrolln Integer Recommended Was subject enrolled 0;1 0=No; 1=Yes
Query enr_d1 Integer Recommended Did Subj. meet Inclu./Exclu.? 0;1 0=No; 1=Yes
Query enr_d2 Integer Recommended Date of case review in days from the Guanfacine enrollment date (ENR_D2 = Date of case review - Guanfacine enrollment date)
Query guan_01 Integer Recommended Presence of a chronic tic disorder 0;1 0=No; 1=Yes
Query guan_02 Integer Recommended History of MPH Non-Response 0;1 0=No; 1=Yes
Query guan_03 Integer Recommended MPH Non-Responder in MPH arm 0;1 0=No; 1=Yes
Query guan_04 Integer Recommended Entered MPH Arm but did not tolerate or had adverse reaction 0;1 0=No; 1=Yes
Query reas01 Integer Recommended Parent refused child take medication 0;1 0=No; 1=Yes q01
Query reas02 Integer Recommended Parent declined other reason 0;1 0=No; 1=Yes q02
Query reas03 Integer Recommended Subject refused to take medication 0;1 0=No; 1=Yes q03
Query reas04 Integer Recommended Subject refused other reason 0;1 0=No; 1=Yes q04
Query reas05 Integer Recommended Failed to return to clinic 0;1 0=No; 1=Yes q05
Query reas06 Integer Recommended Improved prior to randomization 0;1 0=No; 1=Yes q06
Query reas07 Integer Recommended Severe family problems preclude 0;1 0=No; 1=Yes q07
Query reas08 Integer Recommended Failed inclusion criteria 0;1 0=No; 1=Yes q08
Query reas09 Integer Recommended Met exclusion criteria 0;1 0=No; 1=Yes q09
Query reas10 Integer Recommended Other reason 0;1; -9 0=No; 1=Yes; -9=NA q10
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 crossday Integer Recommended Days since MPH trial randomization (CROSSDAY = Guanfacine Enrollment Date - MPH Randomization Date) Derived variable, not on CRF Only applicable to those subjects that participated in both the Randomized MPH Trial and the Guanfacine Trial. Data are blank for all other subjects.
session_id String 20 Recommended session ID/screening ID screeningid
version_form String 121 Recommended Form used/assessment name form_name
Query randrdy Integer Recommended Is subject ready for randomization? 0;1 0=No; 1=Yes
ran004 String 10 Recommended Randomization number/coding rndnum
date_updated Date Recommended Date record updated edit_date
Query elgbsgn Integer Recommended Site PI signed off Eligibility Confirmation form 0;1 0=No;1=Yes
Query dayscons Integer Recommended days since consent cnsntdat
Query mpdat Float Recommended days from enrollment
Query project_status Integer Recommended Current status in project 1::15 1=Evaluation in progress; 2=Refused consent; 3=Ineligible/excluded; 4=Active stage 1; 5=Active stage 2; 6=Active HC control; 7=Completed HC control; 8=Stage 1 complete terminal; 9=Stage 2 complete; 10=Abnormal termination; 11=Withdrew consent; 12=In washout; 13=Dropped out/non compliant; 14=Project Completed; 15=Screened Only status
Query enr04a Integer Recommended Could subject be located 0;1 1=Yes; 0=No
Query sitedatasource_1 Integer Recommended Source of Data: Site 0;1; -888; -999 0=False; 1=True; -888=Not Applicable; -999=Missing; infosrcr
Query sitedatasource_phone Integer Recommended Source of Data: Telephone 0;1; -888; -999 0=False; 1=True; -888=Not Applicable; -999=Missing; infosrct
Query sitedatasource_physician Integer Recommended Source of Data: Physician 0;1; -888; -999 0=False; 1=True; -888=Not Applicable; -999=Missing; infosrcp
Query ssq2a Integer Recommended Any anti-convulsant? 0;1 0 = No; 1 = Yes anticonv, takedrug
Query med_sequence Integer Recommended Med Sequence number seq
Query ci_enrolled Integer Recommended Participant enrolled 0;1 0=No; 1=Yes enrolled
treatment_name String 200 Recommended treatment name treatgrp
suicidesafeplan01 Integer Recommended Create a safety plan with every participant at baseline appointment. Send it to them and save it on box. At post and follow-up visits review safety plan. For people without SI: remind them the plan is available, ask if they want to change anything on their plan, and make sure they have access to a copy. Was a safety plan created /reviewed for/with participant? 0;1 0=No; 1=Yes
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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