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Anticonvulsant Drug Level

242 Shared Subjects

N/A
Clinical Assessments
Treatment
04/13/2015
adl01

View Change History
01
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
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
interview_age Integer Required Age in months at the time of the interview/test/sampling/imaging. 0 :: 1260 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
Query study String 100 Recommended Study; The code for each individual study studyid
Query site String 101 Recommended Site Study Site siteid
Query visit String 60 Recommended Visit name int1, interval
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 adl_q01 Integer Recommended Date of blood draw in days from the randomization date (ADL_Q01 = Date of blood draw - randomization date) drawdate
Query drawtime String 20 Recommended time of blood draw adl_q02
Query adl_q03 Integer Recommended Date of last study med taken in days from the randomization date (ADL_Q03 = Date of last dose of study medication - randomization date) -888=NA datemed
Query adl_q04 String 20 Recommended Time of last study med -888=NA medtime
Query adl_q05 Integer Recommended Date of last anticonvulsant taken in days from the randomization date (ADL_Q05 = Date of last dose of anticonvulsant - randomization date) dateanti
Query adl_q06 String 20 Recommended Time of last anticonvulsant antitime
Query adl_q07a Integer Recommended Phenytoin test ordered 1;2 1=Yes 2=No phenytn
Query adl_q07b Integer Recommended Carbamazepine test ordered 1;2 1=Yes 2=No carbamaz
Query adl_q07c Integer Recommended Valproate test ordered 1;2 1=Yes 2=No valproat
Query adl_q07d Integer Recommended Lamotrigine test ordered 1;2 1=Yes 2=No lamotrig
Query adl_q07e Integer Recommended Gabapentin test ordered 1;2 1=Yes 2=No gabapent
Query adl_q07f Integer Recommended Other1 test ordered 1;2 1=Yes 2=No other1
Query adlq07fs String 50 Recommended Other1 test specify spec1
Query adl_q07g Integer Recommended Other2 test ordered 1;2 1=Yes 2=No other2
adlq07gs String 50 Recommended Other2 test specify spec2
Query daysrz Integer Recommended days since randomization studyday, visitdt
Query blooddraw Integer Recommended Was blood drawn for tests? 1;2 1= Yes 2= No 1 Or 2 Or Is Null blood
Query ci_enrolled Integer Recommended Participant enrolled 0;1 0=No; 1=Yes enrolled
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 wk_seizure_med Integer Recommended Seizure. Medication Used (Details in next section) 0;1 No = 0; Yes = 1;
Query other_reason_nc String 100 Recommended Other reason form was not completed
Query txrisp Integer Recommended treatment risperidone 1;0;-7 0=No; 1=Yes;-7=Refused
Query arioral Integer Recommended Code indicating aripiprazole oral Code=1
Query carbacs Integer Recommended carbamazepine clinic signif 0;1;-7 0=No; 1=Yes; -7=Refused
Query blfnrvallev Float Recommended Non-randomized medication - Valproate level ug/mL
Query iaoth Integer Recommended other action taken 0;1;-4;-5;-6;-7;-8 0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
aef008a String 200 Recommended If other action taken, specify
Query log011 String 50 Recommended Patients chart (e.g., hard copy, electronic, or other medical record) reviewed? 0;1;-888;-999 0=No; 1=Yes; -888=Not Applicable; -999=Missing;
Query valpcs Integer Recommended valproate clinically signif 0;1;-7 0=No; 1=Yes; -7=Refused
Query carbrst Float Recommended Lab test result: Carbamazepine ug/ml
Query lamotrst Float Recommended Lab test result: Lamotrigine ug/ml
Query lamotsg Integer Recommended Lamotrigine: clinically significant 0;1;-7 0=No; 1=Yes; -7=Refused
Query oth1rst Float Recommended Lab test result: Other 1: ug/ml
Query other1sg Integer Recommended Lab test result: Other 1: significant change? 0;1; -7 0=No; 1=Yes; -7=Refused
Query sigp1 Integer Recommended Physician signature present 0;1 0 = No; 1 = Yes
Query sigd1 Integer Recommended Physician/PI signature date (days since randomization)
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
Query study_drug_team String 30 Recommended Study drug Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA
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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