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Data Structures with shared data
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Final Outcomes

0 Shared Subjects

N/A
Clinical Assessments
Exit Form
05/13/2020
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05/13/2020
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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
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 gender
site String 101 Recommended Site Study Site
risk_cs Integer Recommended Clinical status risk level 1;2 1 = Low (Asymptomatic recovery), 2 = High (Symptomatic recovery, Recovering, Prodromal, Continued Symptomatic)
risk_p Integer Recommended Pregnancy risk level 0;1 0 = Low (Not pregnant), 1 = High (Pregnant)
trtarm String 200 Recommended Treatment arm arm
enr_status Integer Recommended Final enrollment status 1::3 1 = Completed study, 2 = Voluntarily withdrew, 3 = Lost to follow up
r_wks Integer Recommended Weeks to relapse -3::47 Total number of weeks to mood episode; - 1 = Baseline only, -2 = Never relapsed final assessment prior to week 48, -3 = Never relapsed
r_cs Integer Recommended Clinical status code at time of relapse -2::8 '-2 = Never relapsed final assessment prior to week 48 , -1 = Baseline assessment only, 0 = Never Relapsed, 5 = Hypomania, 6 = Mania, 7 = Depression, 8 = Mixed
pt_symp Float Recommended Percent time symptomatic -1::100 Percent of weeks assessed with psychiatric status rating > 1.5, -1 = Baseline only
cts_wks Integer Recommended Cumulative weeks symptomatic -1::48 Total number of weeks with psychiatric status rating > 1.5, -1 = Baseline only
ct_wks Integer Recommended Cumulative weeks in study 0::48 Total number of weeks assessed using longitudinal interval evaluation
assess_comp Integer Recommended Number of assessments completed 0::6 Number of planned study assessments completed after baseline assessment at enrollment
assess_last Integer Recommended Final assessment completed 0::12 Assessment month label (Month 0, 2, 4, 6, 8, 10, or 12)
month0_wk Integer Recommended Study week number assessment assigned to If assessment completed Thusday to Sunday assigned to current week otherwise assigned to prior week
month2_wk Integer Recommended Study week number assessment assigned to If assessment completed Thusday to Sunday assigned to current week otherwise assigned to prior week
month4_wk Integer Recommended Study week number assessment assigned to If assessment completed Thusday to Sunday assigned to current week otherwise assigned to prior week
month6_wk Integer Recommended Study week number assessment assigned to If assessment completed Thusday to Sunday assigned to current week otherwise assigned to prior week
month8_wk Integer Recommended Study week number assessment assigned to If assessment completed Thusday to Sunday assigned to current week otherwise assigned to prior week
month10_wk Integer Recommended Study week number assessment assigned to If assessment completed Thusday to Sunday assigned to current week otherwise assigned to prior week
month12_wk Integer Recommended Study week number assessment assigned to If assessment completed Thusday to Sunday assigned to current week otherwise assigned to prior week
month0_strtwk Integer Recommended Study week number of first follow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks start on Mondays
month2_strtwk Integer Recommended Study week number of first follow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks start on Mondays
month4_strtwk Integer Recommended Study week number of first follow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks start on Mondays
month6_strtwk Integer Recommended Study week number of first follow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks start on Mondays
month8_strtwk Integer Recommended Study week number of first follow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks start on Mondays
month10_strtwk Integer Recommended Study week number of first follow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks start on Mondays
month12_strtwk Integer Recommended Study week number of first follow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks start on Mondays
month0_stopwk Integer Recommended Study week number of last folllow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks end on Sundays
month2_stopwk Integer Recommended Study week number of last folllow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks end on Sundays
month4_stopwk Integer Recommended Study week number of last folllow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks end on Sundays
month6_stopwk Integer Recommended Study week number of last folllow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks end on Sundays
month8_stopwk Integer Recommended Study week number of last folllow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks end on Sundays
month10_stopwk Integer Recommended Study week number of last folllow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks end on Sundays
month12_stopwk Integer Recommended Study week number of last folllow back week covered by longitudinal interval evaluation assessment Longitudinal interval evaluation weeks end on Sundays
month0_date String 10 Recommended Date on which assessment interview was completed (MM/DD/YYYY) or not completed (Missed, Withdrew) Assessment month label = 0, Assessment week label in ClinicalTrials.gov = 0, Baseline
month2_date String 10 Recommended Date on which assessment interview was completed (MM/DD/YYYY) or not completed (Missed, Withdrew) Assessment month label = 2, Assessment week label in ClinicalTrials.gov = 8
month4_date String 10 Recommended Date on which assessment interview was completed (MM/DD/YYYY) or not completed (Missed, Withdrew) Assessment month label = 4, Assessment week label in ClinicalTrials.gov = 16
month6_date String 10 Recommended Date on which assessment interview was completed (MM/DD/YYYY) or not completed (Missed, Withdrew) Assessment month label = 6, Assessment week label in ClinicalTrials.gov = 24
month8_date String 10 Recommended Date on which assessment interview was completed (MM/DD/YYYY) or not completed (Missed, Withdrew) Assessment month label = 8, Assessment week label in ClinicalTrials.gov = 32
month10_date String 10 Recommended Date on which assessment interview was completed (MM/DD/YYYY) or not completed (Missed, Withdrew) Assessment month label = 10, Assessment week label in ClinicalTrials.gov = 40
month12_date String 10 Recommended Date on which assessment interview was completed (MM/DD/YYYY) or not completed (Missed, Withdrew) Assessment month label = 12, Assessment week label in ClinicalTrials.gov = 48
month0_strtdate Date Recommended Start date of first follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks start on Mondays
month2_strtdate Date Recommended Start date of first follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks start on Mondays
month4_strtdate Date Recommended Start date of first follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks start on Mondays
month6_strtdate Date Recommended Start date of first follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks start on Mondays
month8_strtdate Date Recommended Start date of first follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks start on Mondays
month10_strtdate Date Recommended Start date of first follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks start on Mondays
month12_strtdate Date Recommended Start date of first follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks start on Mondays
month0_stopdate Date Recommended Stop date of last follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks end on Sundays
month2_stopdate Date Recommended Stop date of last follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks end on Sundays
month4_stopdate Date Recommended Stop date of last follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks end on Sundays
month6_stopdate Date Recommended Stop date of last follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks end on Sundays
month8_stopdate Date Recommended Stop date of last follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks end on Sundays
month10_stopdate Date Recommended Stop date of last follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks end on Sundays
month12_stopdate Date Recommended Stop date of last follow back week covered by longitudinal interval evaluation (MM/DD/YYYY) Longitudinal interval evaluation weeks end on Sundays
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

Please email the The NDA Help Desk with any questions.