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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Across-Trial Core Variables

439 Shared Subjects

N/A
Clinical Assessments
Summary
01/02/2015
mastr01
03/22/2023
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 patid
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
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 elig_criteria Integer Recommended Did patient meet all eligibility criteria? 1::4 1 = Yes 2 = No (waiver) 3 = No (excluded) 4 = Unsure criteria
Query age_c Integer Recommended Patient age at study start (based on Gate C2 date or IVRS enrollment date if Gate C2 date not available)
Query age_a Integer Recommended Patient age at Gate A screening
Query age_b Integer Recommended Patient age at Gate B1 procedures date
Query txnum Integer Recommended Randomized treatment 1::4 1 = Fluoxetine (FLX) 2 = Cognitive BehavioralTherapy (CBT) only 3 = CBT and FLX Combination (COMB) 4 = Placebo (PBO)
Query txcode String 10 Recommended Character coding for treatment assignment COMB; FLX; CBT; PBO Fluoxetine (FLX) Cognitive BehavioralTherapy (CBT) only CBT and FLX Combination (COMB) Placebo (PBO)
Query studydrp Integer Recommended Indicator for Study Dropout 0::4 0 = No 1 = Yes, Stage I 2 = Yes, Stage II 3 = Yes, Stage III 4 = Yes, Stage IV
Query lasstyp Integer Recommended Last assessment completed - if the patient was a study dropout, this represents the last assessment completed prior to dropping out of the study, otherwise it represents the last time period where primary endpoint data (CDRS and CGI scores) was collected 3::13 3 = Gate C1; 4 = Week 6; 5 = Week 12; 6 = Week 18; 7 = Week 24; 8 = Week 30; 9 = Week 36; 10 = Month 3; 11 = Month 6; 12 = Month 9; 13 = Month 12
Query studypmt Integer Recommended Stage I - III: Premature termination indicator [Note: The patient cannot have a premature termination in Stage IV] 0::3 0 = No 1 = Yes, Stage I 2 = Yes, Stage II 3 = Yes, Stage III
Query pmtlasst Integer Recommended Stage I - III: Last assessment completed prior to premature termination [Note: The patient cannot have a premature termination in Stage IV] 3::8 3 = Gate C1; 4 = Week 6; 5 = Week 12; 6 = Week 18; 7 = Week 24; 8 = Week 30
Query wk6comp Integer Recommended Indicator for Week 6 visit completed - based on presence of CDRS or CGI forms for Week 6 0;1 0 = No; 1 = Yes
Query wk12comp Integer Recommended Indicator for Week 12 visit completed - based on presence of CDRS or CGI forms for Week 12 0;1 0 = No; 1 = Yes
Query wk18comp Integer Recommended Indicator for Week 18 visit completed based on presence of CDRS or CGI forms for Week 18 0;1 0 = No; 1 = Yes
Query wk24comp Integer Recommended Indicator for Week 24 visit completed - based on presence of CDRS or CGI forms for Week 24 0;1 0 = No; 1 = Yes
Query wk30comp Integer Recommended Indicator for Week 30 visit completed based on presence of CDRS or CGI forms for Week 30 0;1 0 = No; 1 = Yes
Query wk36comp Integer Recommended Indicator for Week 36 visit completed - based on presence of CDRS or CGI forms for Week 36 0;1 0 = No; 1 = Yes
Query mo3comp Integer Recommended Indicator for Month 3 visit completed based on presence of CDRS or CGI forms for Month 3 0;1 0 = No; 1 = Yes
Query mo6comp Integer Recommended Indicator for Month 6 visit completed - based on presence of CDRS or CGI forms for Month 6 0;1 0 = No; 1 = Yes
Query mo9comp Integer Recommended Indicator for Month 9 visit completed - based on presence of CDRS or CGI forms for Month 9 0;1 0 = No; 1 = Yes
Query mo12comp Integer Recommended Indicator for Month 12 visit completed - based on presence of CDRS or CGI forms for Month 12 0;1 0 = No; 1 = Yes
Query completr Integer Recommended Stage I: Stage I completer population, defined as completed a Week 12 assessment while in the randomized arm (did not dropout or prematurely terminate prior to Week 12). 0;1 0 = No; 1 = Yes
Query pmtt0 Float Recommended Stage I - III: Weeks from Time 0 to premature termination
Query sdot0 Float Recommended Weeks from Time 0 to last assessment or treatment session
Query pstpmttx String 10 Recommended Stage I: Post-PMT TADS treatment received (only for patients that prematurely terminated) during Stage I COMB; FLX; CBT; NONE Fluoxetine (FLX) Cognitive BehavioralTherapy (CBT) only CBT and FLX Combination (COMB) None
Query lpmtwk1 Integer Recommended Stage I: Premature termination timing: This represents the last study week in which the teen started the week in the assigned arm (pre-PMT). Only available for those patients that prematurely terminated in Stage I. 1::12;99 99 = Stage I > 12 weeks
Query lsdowk1 Integer Recommended Stage I: Study dropout timing: This variable represents the last study week in which the teen started the week as a non-dropout. Only available for those patients that dropped out of the study during Stage I. 1::12;99 99 = Stage I > 12 weeks
Query lpmtsdo1 Integer Recommended Stage I: Premature termination or study dropout timing: This variable represents the last study week in which the teen started the week as an active participant in the assigned treatment arm. Only available for those patients that prematurely terminated or dropped out of the study during Stage I. 1::12;99 99 = Stage I > 12 weeks
Query s1txsw Integer Recommended Stage I: End of Stage I Treatment switch flag. Stage I study dropout or PMT or final CGIt-I value > 3 considered to have not continued in randomized treatment arm at the end of Stage I for patients in the active treatment arm. 0::2 0 = FLX, CBT, & COMB arms: Did not continue in randomized treatment arm; 1 = FLX, CBT, & COMB arms: Continued in randomized treatment arm; 2 = PBO patient
Query oclastt0 Float Recommended Stage I - III: Observed Cases: Weeks from randomization to last treatment session date or assessment date based on premature termination/study dropout status and coded value for Stage I treatment switch flag. This applies to Stages I through III only.
Query oclastas Integer Recommended Stage I - III: Observed Cases: Last assessment visit based on premature termination/study dropout status and coded value for Stage I treatment switch flag. This applies to Stages I through III only. 1::9 3 = Gate C1; 4 = Week 6; 5 = Week 12; 6 = Week 18; 7 = Week 24; 8 = Week 30; 9 = Week 36
Query lpmtwk3 Integer Recommended Stage I - III: Premature termination timing: This represents the last study week in which the teen started the week in the assigned arm (pre-PMT). This is counting the true number of weeks from Time 0 regardless of Week 12, Week 18 or Week 36 timing.Only available for those patients that prematurely terminated in Stage I through Stage III. 1::36;99 99 = > 36 weeks
Query lsdowk3 Integer Recommended Stage I - III: Study dropout timing: This variable represents the last study week in which the teen started the week as a non-dropout. This is counting the true number of weeks from Time 0 regardless of Week 12, Week 18 or Week 36 timing.Only available for those patients that dropped out of the study during Stage I through Stage III. 1::36;99 99 = > 36 weeks
Query lpmtsdo3 Integer Recommended Stage I - III: Premature termination or study dropout timing: This variable represents the last study week in which the teen started the week as an active participant in the assigned treatment arm. This is counting the true number of weeks from Time 0 regardless of Week 12, Week 18 or Week 36 timing.Only available for those patients that prematurely terminated or dropped out of the study during Stage I through Stage III. 1::36;99 99 = > 36 weeks
Query lsdowk4 Integer Recommended Stage I - IV: Study dropout timing: This variable represents the last study week in which the teen started the week as a non-dropout. This is counting the true number of weeks from Time 0 regardless of Week 12, Week 18, Week 36 orMonth 12 timing.Only available for those patients that dropped out in Stage I through Stage IV. 1::88;99 99 = > 88 weeks
Query ethnicity String 30 Recommended Ethnicity of participant
Hispanic or Latino; Not Hispanic or Latino; Unknown
Query stcomp Integer Recommended Stage V: SOFTAD study completion status 1;2 1 = Completed SOFTAD month 42; 2 = Dropped out of SOFTAD before month 42
Query stlast Integer Recommended Stage V: SOFTAD last assessment 14::20 14 = SOFTAD month 6; 15 = SOFTAD month 12; 16 = SOFTAD month 18; 17 = SOFTAD month 24; 18 = SOFTAD month 30; 19 = SOFTAD month 36; 20 = SOFTAD month 42
Query age_e Float Recommended Stage V: Age at SOFTAD enrollment visit
Query stlastmo Float Recommended Stage V: Mos., TADS Time0 last asst.
Query stlast_m Float Recommended Stage V: Mos., SOFTAD enr. - last asst.
Query stdor1 Integer Recommended Dropout -subject moved and participation is no longer possible 0;1 1 = Yes; 0=No
Query stdor2 Integer Recommended Dropout - lost to follow-up 1;0 1 = Yes; 0=No
Query stdor3 Integer Recommended Dropout-consent withdrawn 1;0 1 = Yes; 0-No
Query stdor4 Integer Recommended Stage V: Dropout-teen pregnancyTeen is pregnant 1 1 = Yes
Query stdor5 Integer Recommended Dropout-adverse event 1;0 1 = Yes; 0=No
Query stdor6 Integer Recommended Dropout-subject' death 1;0 1 = Yes; 0=No
Query stdor7 Integer Recommended Dropout-other reason 1;0 1 = Yes; 0=No
Query stdor8 Integer Recommended Dropout-unknown reason 1;0 1 = Yes; 0=No
Query stdor3_s String 100 Recommended Stage V: Dropout-consent withdrawn, sp.
stdor5_s String 40 Recommended Stage V: Dropout-adverse event, spec.
stdor6_s String 40 Recommended Stage V: Dropout-death, spec.
Query stdor7_s String 255 Recommended Stage V: Dropout-other reason, spec.
Query visit String 60 Recommended Visit name enr_vis
Query enr_ast Integer Recommended SOFTAD enrollment assessment type 14::20
Query ste_m Float Recommended SOFTAD enrollment: mos. from TADS Time0
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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