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Study Completion Questionnaire

472 Shared Subjects

N/A
Clinical Assessments
Exit Form
06/26/2020
abc_ct_scq01
08/04/2023
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
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::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.
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
date_study_completed Date Recommended Date Study Completed
re_stu_comp_adi_ineligible Integer Recommended Reason for Study Completion (Screener passed: Ineligible due to ADI-R) 0;1 0=No; 1=Yes reason_study_completion_adi_ineligible
re_stu_comp_ados_ineligible Integer Recommended Reason for Study Completion (Screener Passed: Ineligible due to ADOS) 0;1 0=No; 1=Yes reason_study_completion_ados_ineligible
re_stu_comp_casi_ineligible Integer Recommended Reason for Study Completion (Screener Passed: Ineligible due to CASI) 0;1 0=No; 1=Yes reason_study_completion_casi_ineligible
re_stu_comp_consent_withdrawn Integer Recommended Reason for Study Completion (Consent Withdrawn) 0;1 0=No; 1=Yes reason_study_completion_consent_withdrawn
re_stu_comp_das_ineligible Integer Recommended Reason for Study Completion (Screener Passed: Ineligible due to DAS) 0;1 0=No; 1=Yes reason_study_completion_das_ineligible
fail_com_eeg_et Integer Recommended Reason for Study Completion (Failure to complete BOTH Eye Tracking AND EEG on Timepoint 1) 0;1 0=No; 1=Yes reason_study_completion_failed_complete_eeg_et
lost_fol_up Integer Recommended Reason for Study Completion (Lost to follow-up) 0;1 0=No; 1=Yes reason_study_completion_lost_follow_up
re_stu_comp_other Integer Recommended Reason for Study Completion (Other) 0;1 0=No; 1=Yes reason_study_completion_other
re_stu_comp_other_desc String 200 Recommended If Other reason study was completed, please describe: reason_study_completion_other_please_describe
re_stu_comp_scrn_other Integer Recommended Reason for Study Completion -Screener Passed - Other 0;1 0=No; 1=Yes reason_study_completion_screener_passed_other
scrn_pass_other_spec String 200 Recommended If Screener Passed: Other was selected, please describe: reason_study_completion_screener_passed_other_specify
study_meas_comp Integer Recommended Reason for Study Completion (Study measures completed) 0;1 0=No; 1=Yes reason_study_completion_study_measures_completed
re_stu_comp_time_inelig Integer Recommended Reason for Study Completion (timepoint_ineligible) 0;1 0=No; 1=Yes reason_study_completion_timepoint_ineligible
re_stu_comp_failed_to_come_t1 Integer Recommended Reason for Study Completion (Failed to come to Timepoint 1) 0;1 0=No; 1=Yes reason_study_completion_failed_to_come_t1
stu_comp_point Integer Recommended Study Completion Point based on time point (T1, T2 or T3), and day (D1 or D2) 1::7 1=Prior to T1 data collection; 2=T1D1 data collection;3=T1D2 data collection; 4=T2D1 data collection; 5=T2D2 data collection; 6=T3D1 data collection; 7=T3D2 data collection study_completion_point
version_form String 121 Recommended Form used/assessment name
derived_results_version String 20 Recommended Analysis pipeline identifier for version results
abc_ct_study String 200 Recommended ABC-CT Study: T4 Follow-Up, Confirmation; Pediatric Feasibility
t4_term_point Integer Recommended T4 Follow-Up Study termination point 1 :: 8 1=Withdrew consent at Main Study; 2=Lost to follow-up (Unable to contact prior to Screening contact); 3=Successfully re-contacted, but declined participation (Screener not completed); 4=Screened (Completed screener, but did not consent); 5 = Discontinued (Completed screener and consent but did not complete additional measures); 6=Virtual clinical measures only (Completed parent packet and/or Vineland and/or ADI-R); 7=T4D1 (Completed T4D1, but did not return for T4D2, or amidst Parent Packet); 8=T4D2 (Completed all T4 assessments, no show or other reason during the D2 visit)
t4_term_reason Integer Recommended T4 Follow-Up Study termination reason 1 :: 9 1=All data provided (To be used for families who completed all T4 assessments); 2=Declined participation, completed Screener (To be used for families who are re-contacted and have completed the screener, but decide not to participant and consent. The reason will be coded in the screener.); 3= Declined participation, did not complete Screener (To be used for families who were successfully re-contacted, but declined to participate before initiating Screener); 4=Consent Withdrawn (To be used only for families who withdrew consent during the main study and families who withdraw consent during T4); 5=Failed to come to T4D1 (To be used for families who complete screener, consent, and virtual assessments (parent packet, Vineland, ADI-R) and did not come in person for T4D1); 6=Failed to come to T4D2 (To be used for families who complete T4D1 in person visit but do not return for T4D2); 7=Other; 8=Unable to contact prior to Screening (Choice if Study Termination Point = 2=Lost to follow up (Unable to contact prior to Screening contact); 9=Discontinued (Completed screener and consent but did not complete additional measures)
t4_term_reason_other String 200 Recommended T4 Follow-Up Study termination reason Other description
cs_exit_point Integer Recommended Confirmation Study exit point 1 :: 4 1=Prior to CT1 data collection; 2=CT1 Data Collection; 3=CT2 Data Collection; 4=CT3 Data Collection
cs_exit_reason Integer Recommended Confirmation Study exit reason 1 :: 10 1=CS Screener Passed: Consent not fully executed; 2=CS Screener Passed: Consent Withdrawn; 3=CS Screener passed: Failed to come to Timepoint 1; 4=CS Screener passed: Other (not specified above); 5=CS Ineligible due to diagnostic disqualification at CT1(ADI-R, ADOS2/BOSA, DSM-5, and/or CASI-5); 6=CS Ineligible due to IQ-disqualification at CT1 (DAS-II); 7=CS Did not provide any valid biomarker (ET/EEG) data at CT1; 8=CS Lost to Follow Up; 9=CS Study measures/participation completed; 10=CS Other (not specified above)
cs_exit_reason_other String 500 Recommended Confirmation Study exit reason other description
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.