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Change in Study Status

611 Shared Subjects

N/A
Clinical Assessments
Exit Form
06/10/2015
cssp01
06/15/2015
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* guid
src_subject_id String 20 Required Subject ID how it's defined in lab/project pid
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.
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported
Query phase_cts Integer Recommended Phase I (12-weeks) Phase II (6-months) 1;2 1 = Phase I - Participants were randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo. 2 = Phase II - Maintenance period for participants who responded to any of the three active treatments. phase, phase_ct, phase_p
Query change_s Integer Recommended Type of study status change 1;2;3 1 = Study Dropout;2 = Treatment Dropout;3 = Pre-mature Termination change
stdate Date Recommended Study Treatment stop date daypmt, daytxdr
Query daydrop Integer Recommended Study Dropout - day of study drop
Query wkstdrop Integer Recommended Study week subject drops out of study 0::36 0 = prior to Week 1;1 = Week 1;36 = Week 36 wkpmt, wktxdrop
sd_othrs String 80 Recommended Study Dropout - description of other reason
erlrsmds String 255 Recommended Describe reason for early termination tx_othrs, whatothr_p
Query trminatn Integer Recommended Premature Termination - Nature of the premature termination 1;2 1 = Assigned study treatment discontinued all or in part;2 = Study treatment continued but out-of-protocol intervention added
Query whatfx String 60 Recommended Description of intolerable side-effects
Query daylasttx Integer Recommended Study day last regular treatment session was completed
Query daymstrecnt Integer Recommended Study day most recent scheduled assessment was completed
Query cssyorn Integer Recommended Was a change in study status assessment completed? 0;1 0 = No;1 = Yes
Query daycss Integer Recommended Study day change in study status form was completed
Query dayfinl Integer Recommended Study day final assessment was completed
Query asapform Integer Recommended Was an ASAP form completed? 0;1 0 = No;1 = Yes
Query dayasap_p Integer Recommended Study day ASAP initiated
Query asapanel Integer Recommended Presented to cross-site ASAP Panel? 0;1 0 = No;1 = Yes
Query daypanl Integer Recommended Study day of ASAP Panel
Query daychange Integer Recommended Study day of change in study status assessment
Query changewk Integer Recommended Study week of change in study status assessment
Query stdor1 Integer Recommended Dropout -subject moved and participation is no longer possible 0;1 1 = Yes; 0=No sd_moved
Query stdor2 Integer Recommended Dropout - lost to follow-up 1;0 1 = Yes; 0=No sd_lost
Query stdor3 Integer Recommended Dropout-consent withdrawn 1;0 1 = Yes; 0-No sd_wthdr
Query stdor5 Integer Recommended Dropout-adverse event 1;0 1 = Yes; 0=No sd_advev, tx_advev
Query stdor6 Integer Recommended Dropout-subject' death 1;0 1 = Yes; 0=No sd_died
Query stdor8 Integer Recommended Dropout-unknown reason 1;0 1 = Yes; 0=No sd_unkn, tx_unknw
Query stdor7 Integer Recommended Dropout-other reason 1;0 1 = Yes; 0=No sd_other, tx_other
Query tx_attnd Integer Recommended Unable to attend treatment sessions 0;1 0 = No;1 = Yes
Query tx_noint Integer Recommended No longer interested in participating 0;1 0 = No;1 = Yes
Query preg Integer Recommended patient become pregnant 0;1;-7 0=No; 1=Yes; -7=Refused TX_PREG
Query tx_cnsnt Integer Recommended Child/parent withdrew consent for treatment 0;1 0 = No;1 = Yes
Query tx_nocbt Integer Recommended Do not want to participate in CBT 0;1 0 = No;1 = Yes
Query tx_nopbo Integer Recommended Do not want to risk possibility of taking PLACEBO 0;1 0 = No;1 = Yes
Query tx_nomed Integer Recommended Do not want to risk possibility of taking meds 0;1 0 = No;1 = Yes
Query psycotic Integer Recommended Subject became psychotic 0;1 0 = No;1 = Yes
Query manic Integer Recommended Subject became manic 0;1 0 = No;1 = Yes
Query hypomanc Integer Recommended Subject became hypomanic 0;1 0 = No;1 = Yes
Query agitated Integer Recommended Subject displayed agitation/disinhibition 0;1 0 = No;1 = Yes
Query nosucont Integer Recommended Subject became suicidal 0;1 0 = No;1 = Yes
Query chrt_que2 Integer Recommended Patient made a suicide attempt 0;1 0=No; 1=Yes suiatmpt
Query chronill Integer Recommended Chronic medical illness 0;1 0 = No;1 = Yes illness
Query medintefere Integer Recommended Use of medications that interfere with study 0;1 0 = No;1 = Yes meds
Query subabuse Integer Recommended curr substance abuse or depend 0;1;-7 0=No; 1=Yes; -7=Refused
Query pregnant Integer Recommended Patient is currently pregnant 0::2;-7; 999 0=No; 1=Yes;2=DK;-7= Refused; 999=Legimately skipped
Query nocontct Integer Recommended Unable to contact 0;1 0 = No;1 = Yes
Query worscond Integer Recommended Condition substantially worse 0;1 0 = No;1 = Yes
Query norespns Integer Recommended Lack of clinical response 0;1 0 = No;1 = Yes
Query anclrytx Integer Recommended Subject requires ancillary treatment 0;1 0 = No;1 = Yes
Query sidefx Integer Recommended Intolerable side-effects 0;1 0 = No;1 = Yes
Query otherrsn Integer Recommended Premature termination. Other reason 0;1 0 = No;1 = Yes
comments_misc String 4,000 Recommended Miscellaneous comments on study, interview, methodology relevant to this form data
study String 100 Recommended Study; The code for each individual study
Query trtgroup String 2 Recommended Treatment Group N1;N2;R1;R2;R3 N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
Query q18_8d Integer Recommended Result of contact: Blind broken 0; 1; -7; -8; -9 Complete only if q18_8 = 1
Query medication1_name String 500 Recommended Name first medication that the participant has taken 0 = No medication; 999= Legitimately skipped
Query medication2_name String 200 Recommended Name second medication that the participant has taken 0 = No medication; 999= Legitimately skipped
Query medication3_name String 150 Recommended Name third medication that the participant has taken 0 = No medication; 999= Legitimately skipped
medication4_name String 100 Recommended Name fourth medication that the participant has taken 0 = No medication; 999= Legitimately skipped
Query week Float Recommended Week in level/study 99=week 10-week 14
Query site String 101 Recommended Site Study Site
ancitx1 String 100 Recommended description of treatment
Query ncpill Integer Recommended Non-compliance - Pill count 0;1 0=No; 1=Yes
Query schprb Integer Recommended Subject has scheduling problems 0;1 0=No; 1=Yes
Query lengass Integer Recommended Subject has problems with length of assessment 0;1 0=No; 1=Yes
Query moved Integer Recommended Patient has moved away 0;1;-7 0=No; 1=Yes; -7=Refused
Query personn Integer Recommended Subject doesn't like research staff 0;1 0=No; 1=Yes
Query nrespd Integer Recommended Subject is a non-responder 0;1 0=No; 1=Yes
Query ieeval Integer Recommended Subject agreed to IE evaluation? 0;1 0=No; 1=Yes
Query nc3ses Integer Recommended Subject missed 3 sessions without rescheduling 0;1 0=No; 1=Yes
Query aescode Integer Recommended Staff code number of person completing this form 999= Missing Data
Query ctf_1 Integer Recommended Subject received extension phase packet 0;1 0=No; 1=Yes
Query compprot Integer Recommended Completed treatment protocol 0;1;-7 0=No; 1=Yes; -7=Refused
Query violate Integer Recommended Protocol Violation 0;1 0=No; 1-Yes
Query hardcode String 1,200 Recommended Significant Protocol Violation Textual description of the protocol violation
Query stdor3_s String 100 Recommended Stage V: Dropout-consent withdrawn, sp.
Query termin_day Integer Recommended Days since baseline that clinic officially terminated the subject
Query ae String 250 Recommended Adverse event 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

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