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Filter Cart

Viewable at the top right of NDA pages, the Filter Cart is a temporary holder for filters and data they select. Filters are added to the Workspace first, before being submitted to The Filter Cart. Data selected by filters in the Filter Cart can be added to a Data Package or an NDA Study from the Data Packaging Page, by clicking the 'Create Data Package / Add Data to Study' button.

The filter cart supports combining multiple filters together, and depending on filter type will use "AND" or "OR"  when combining filters.

Multiple selections from the same filter type will result in those selections being applied with an ‘OR’ condition. For example, if you add an NDA Collection Filter with selections for both collections 2112 and 2563 to an empty Workspace, the subjects from NDA Collection 2112 ‘OR’ NDA Collection 2563 will be added to your Workspace even if a subject is in both NDA Collections. You can then add other NDA Collections to your Workspace which further extends the ‘OR’ condition.

If a different filter type is added to your Workspace, or a filter has already been submitted to the Filter Cart, the operation then performs a logical ‘AND’ operation. This means that given the subjects returned from the first filter, only those subjects that matched the first filter are returned by the second filter (i.e., subjects that satisfied both filters). Note that only the subjects specific to your filter will be added to your Filter Cart and only on data shared with the research community. Other data for those same subjects may exist (i.e., within another NDA Collection, associated with a data structure that was not requested in the query, etc.). So, users should select ‘Find all Subjects Data’ to identify all data for those specific subjects. 

Additional Tips:

  • You may query the data without an account, but to gain access you will need to create an NDA user account and apply for access.  Most data access requires that you or your lab are sponsored by an NIH recognized institution with Federal Wide Assurance (FWA).  Without access, you will not be able to obtain individual-level data. 

    Once you have selected data of interest you can:
  • Create a data package - This allows you to specify format for access/download
  • Assign to Study Cohort - Associate the data to an NDA Study allowing for a DOI to be generated and the data to be linked directly to a finding, publication, or data release. 
  • Find All Subject Data - Depending on filter types being used, not all data associated with a subject will be selected.  Data may be restricted by data structure, NDA Collection, or outcome variables (e.g., NDA Study). ‘Find All Data’ expands the fliter criteria by replacing all filters in your Filter Cart with a single Query by GUID filter for all subjects selected by those filters.

    Please Note:
  • When running a query, it may take a moment to populate the Filter Cart. Queries happen in the background so you can define other queries during this time. 
  • When you add your first filter, all data associated with your query will be added to the Filter Cart (e.g., a Concept, an NDA Collection, a Data Structure/Element, etc.). As you add additional filters, they will also display in the Filter Cart. Only the name of filter will be shown in the Filter Cart, not the underlying structures. 
  • Information about the contents of the Filter Cart can be seen by clicking "Edit”.
  • Once your results appear in the Filter Cart, you can create a data package or assign subjects to a study by selecting the 'Package/Assign to Study' option. You can also 'Edit' or 'Clear' filters.
     

Frequently Asked Questions

  • The Filter Cart currently employs basic AND/OR Boolean logic. A single filter may contain multiple selections for that filter type, e.g., a single NDA Study filter might contain NDA Study 1 and NDA Study 2. A subject that is in EITHER 1 OR 2 will be returned.  Adding multiple filters to the cart, regardless of type, will AND the result of each filter.  If NDA Study 1 and NDA Study 2 are added as individual filters, data for a subject will only be selected if the subject is included in  BOTH 1 AND 2.

  • Viewable at the top right of NDA pages, the Filter Cart is a temporary holder of data identified by the user, through querying or browsing, as being of some potential interest. The Filter Cart is where you send the data from your Workspace after it has been filtered.

  • After filters are added to the Filter Cart, users have options to ‘Create a Package’ for download, ‘Associate to Study Cohort’, or ‘Find All Subject Data’. Selecting ‘Find All Subject Data’ identifies and pulls all data for the subjects into the Filter Cart. Choosing ‘Create a Package’ allows users to package and name their query information for download. Choosing ‘Associate to Study Cohort’ gives users the opportunity to choose the Study Cohort they wish to associate this data.

Glossary

  • Once your filter cart contains the subjects of interest, select Create Data Package/Assign to Data Study which will provide options for accessing item level data and/or assigning to a study.  

  • Once queries have been added to your workspace, the next step is to Submit the Filters in the workspace to the Filter Cart.  This process runs the queries selected, saving the results within a filter cart attached to your account.  

  • The Workspace within the General Query Tool is a holding area where you can review your pending filters prior to adding them to Filter Cart. Therefore, the first step in accessing data is to select one or more items and move it into the Workspace. 

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End of Study Form

8,462 Shared Subjects

Clinical Trials: End of Study Form
Clinical Assessments
Exit Form
05/07/2014
endstudy01
05/28/2020
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 CATIEID, bid, case_id, id, randid, record_id, stepid, subject_id
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. bslage, intvage
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY Required field eosdt, intvdate, subsum_doa
sex String 20 Required Sex of the subject M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
Query visitid Integer Recommended MetaTrial Visit ID System variable: unique code for each type of visit -use to merge files
Query visit String 60 Recommended Visit name vtypdhs
Query truncvis Integer Recommended Truncated Visit Number Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
Query phase_ct String 20 Recommended Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1
Query visday Integer Recommended Number of days from study baseline to date of visit date
protocol String 50 Recommended Protocol [Study] name
Query eos1 Integer Recommended Did the patient complete the medication portion 0;1 0=No; 1=Yes
Query eos1a Integer Recommended Day of study completion Number of days from study baseline to date of study completion eos01a
Query eos1b Integer Recommended Day of medication withdrawal Number of days from study baseline to date of medication withdrawal eos01b
Query eos2 String 20 Recommended Patient's final medication phase? Phase 1 or 1a; Phase 1b; Phase 2; Phase 3; Open-choice eos02
Query eos3 Integer Recommended Indicate who initiated the discontinuation 1::4 1=Investigator; 2=Patient; 3=Subject advocate; 4=caregiver eos03
Query eos4 Integer Recommended Primary reason for withdrawal 1::6 1=Administrative reason, specify; 2=Patient refused to continue to next phase; 3=Adverse event precluding further study phase; 4=Other reason; 5=Caregiver/legal authorized representative; 6=Patient Death eos04
Query eos5 Integer Recommended Investigator has signed end of study 1; 0 1=yes; 0=no eos05
Query eos6 Integer Recommended Is the patient proceeding to the follow up phase? 0;1 0=No; 1=Yes
Query eos7 Integer Recommended Did the patient sign the follow up Informed Consnt? 0::2 0=No; 1=Yes; 2=unable to contact fuconsnt
Query eos8 Integer Recommended Day follow up Informed Consent was signed? Number of days from study baseline to date follow up informed consent was signed consdate
level String 10 Recommended Treatment level
Query week Float Recommended Week in level/study 99=week 10-week 14
crcid String 40 Recommended CRC ID/ROA ID
Query update Integer Recommended Updated form 0;1 1= yes; 0= no
Query etlck Integer Recommended Lack of efficacy 0;1 0=Not checked; 1=Checked
Query eteff Integer Recommended Unacceptable side effects 0;1 0=Not checked; 1=Checked
Query etcmats Integer Recommended Committed/ suicide attempt 0;1; -9 0=Not checked; 1=Checked; -9 =Unknown
Query etmscdn Integer Recommended Generalized condition req prtcl stop 0;1 0=Not checked; 1=Checked
Query etdsym Integer Recommended Symptoms req nonprotocol treatment 0;1 0=Not checked; 1=Checked
Query etfret Integer Recommended Failed to return to clinic 0;1 0=Not checked; 1=Checked
Query etmvd Integer Recommended Moved from the area 0;1 0=Not checked; 1=Checked
Query etnapro Integer Recommended Non-adherence to study proc. 0;1 0=Not checked; 1=Checked
Query etnamed Integer Recommended Non-adherence to study medication 0;1 0=Not checked; 1=Checked
Query etrebur Integer Recommended Found research too burdensome 0;1 0=Not checked; 1=Checked
Query etwcnr Integer Recommended Patient withdrew with no reason 0;1 0=Not checked; 1=Checked
Query etpreg Integer Recommended Patient became pregnant 0;1 0=Not checked; 1=Checked
Query etnorandgen Integer Recommended Could not randomize due to gen. med cond. 0;1 0=Not checked; 1=Checked
Query etnorandmed Integer Recommended Could not randomize, PT is on concomitant med 0;1 0=Not checked; 1=Checked
Query duedate String 30 Recommended Due date
Query dayscons Integer Recommended days since consent
Query site String 101 Recommended Site Study Site site_no
Query certcode Integer Recommended stepbd certification code
Query pcsf Integer Recommended pcos screening form completed 0;1;-7 0=No; 1=Yes; -7=Refused
Query pcec Integer Recommended pcos eligibility completed 0;1;-7 0=No; 1=Yes; -7=Refused
Query pcexm Integer Recommended pcos exam form completed 0;1;-7 0=No; 1=Yes; -7=Refused
Query pcmhq Integer Recommended pcos menstrual hist completed 0;1;-7 0=No; 1=Yes; -7=Refused
Query bloodsmp Integer Recommended blood samples collected 0::4;-7 1 = Yes; 0 = No/Participant unable to complete; 2 = Not applicable; 3 = Participant refused; 4 = Not collected (other)
Query bloodsuf Integer Recommended blood samples sufficient 0;1;-7 0=No; 1=Yes; -7=Refused
Query ultsndcn Integer Recommended consented to ultrasound 0;1;-7 0=No; 1=Yes; -7=Refused
Query pcurf Integer Recommended pcos ultrasound form completed 0;1;-7 0=No; 1=Yes; -7=Refused
Query pccur Integer Recommended pcos central ultsnd completed 0;1;-7 0=No; 1=Yes; -7=Refused
Query pcosunab Integer Recommended pcos pt unable comp req assmts 0;1;-7 0=No; 1=Yes; -7=Refused
Query pcosnoas Integer Recommended pcos pt not return assessments 0;1;-7 0=No; 1=Yes; -7=Refused
Query pcosnoat Integer Recommended pcos pt did not attend eval 0;1;-7 0=No; 1=Yes; -7=Refused
Query pcoshosp Integer Recommended patient hospitalized 0;1;-7 0=No; 1=Yes; -7=Refused
Query pcosnocm Integer Recommended pcos assmts not compl in 6mo 0;1;-7 0=No; 1=Yes; -7=Refused
Query pcosothr Integer Recommended pcos missed other reason 0;1;-7 0=No; 1=Yes; -7=Refused
Query rinact Integer Recommended reason for inactivation 1::9 1=Death; 2=Too sick/unstable; 3=Relocated; 4=Untraceable; 5=Drop out; 6=Incomplete study entry; 7=Ineligible, specify; 8=Other, specify; 9=Completed 24 month follow up
Query suicide Integer Recommended Was the death because of a suicide? 0;1; 999 0 = No; 1 = Yes; 999 = Legitimately Skipped dsuicide
Query inactcon Integer Recommended inact days since consent
Query lifedx1 String 50 Recommended Lifetime diagnosis 1
Query lifedxsp String 50 Recommended Lifetime diagnosis specify
Query trt_grp String 10 Recommended Treatment Group Assignment 1;1AO;1CT;2; 3;4;5;6;7;8;9;10 1=Group 1 first 8 weeks; 1AO=Group 1 8 week add on; 1CT=Group 1 8 week cross taper; 2=Group 2; 3=Group 3; 4 =active; 5=sham; 6=none; 7=ESDM High intensity; 8=ESDM Low intensity; 9=EIBI High intensity; 10=EIBI Low intensity; ESDM = Early Start Denver Model; EIBI = Early and Intensive Behavioral Intervention
Query days_baseline Integer Recommended Days since baseline bsldays
Query etype String 10 Recommended Rating Period BSL;WK1;WK2;WK3;WK4;WK5;WK6;WK7;WK8;WK9;WK10;WK11;WK12;WK13;WK14;WK15;WK16 BSL=Baseline; WK1-WK16=Weeks 1-16
Query respond_detail_oth_spec String 255 Recommended Respondent details informnt
Query relationship Integer Recommended Relationship of respondent to individual
1::93;-999
1 = Biological mom; 2 = Biological dad; 3 = Grandparent; 4 = Special education (sped) teacher; 5 = General education teacher; 6 = Occupational therapist; 7 = Speech and language therapist; 8 = Behavioral therapist; 9 = Paraprofessional; 10 = Aide; 11 = Principal; 12 = Administrator; 13 = 90=Other; 14 = Content teacher; 15 = Parent center director; 16 = Self; 17=Adoptive mother; 18=Adoptive father; 19=Foster mother; 20 = Foster father; 21=Grandmother; 22=Grandfather; 23=Step-mother; 24 = Step-father; 25=Aunt; 26=Uncle; 27=Missing Data; 28=Both parents;31= Grandmother from mother side; 32= Grandfather from mother side; 33= Grandmother from father side; 34= Grandfather from father side; 36= Brother; 37= Sister; 38= Cousin; 39= female caregiver; 40=male caregiver; 41=Female child; 42=Male child; 43=Spouse/Mate; 44=Friend; 45=Parent; 46=Significant other; 47=Sibling; 48=Son/Daughter; 49=Son-in-law/Daughter-in law; 50=Other Relative; 51=Paid caregiver; 52=Friends; 53=Roommate; 54=Supervisor; 55=mother's boyfriend; 56=other parental figure; 57=Summary; 58=counselor ; 59 = other female relative; 60 = other male relative; 61 = non-relative ; 62=Maternal Aunt; 63=Maternal Uncle; 64=Maternal Cousin; 65 = Paternal Aunt; 66=Paternal Uncle; 67=Paternal Cousin ; 68=Biological/Adoptive Mother and Grandmother; 69=Biological/Adoptive Mother and Stepmother and Grandmother; 70=Biological/Adoptive Mother and Grandmother and Foster Father; 71=Biological/Adoptive Mother and Stepmother and Foster Mother; 72=Biological/Adoptive Mother and Foster Mother; 73=Biological/Adoptive Mother and Biological/Adoptive Father; 74=Biological/Adoptive Mother and Stepmother and Biological/Adoptive Father; 75=Biological/Adoptive Mother and Other; 76=Biological/Adoptive Mother and Stepmother and Stepfather; 77=Biological/Adoptive Mother and Stepfather; 78=Biological/Adoptive Mother and Grandfather; 79=Biological/Adoptive Mother and Stepmother and Foster Father; 80=Biological/Adoptive Mother and Stepmother; 81=Guardian, female; 82=Other female; 83=Guardian, male; 84=Other male; 85=Other/Grandparent/Nanny; 86 = Mother, Father, Guardian; 87 = Daughter, son, grandchild; 88 = Professional (e.g., social worker, nurse, therapist, psychiatrist, or group home staff); -999=Missing; 89 = Biological parent; 91 = Stepparent; 92 = Adoptive parent; 93 = Foster parent infrmnt2
Query esfref Integer Recommended Referral for clinical care given 0::2 0=N/A; 1=no; 2=yes
Query esfltr Integer Recommended End of study letter sent 0::2 0=N/A; 1=no; 2=yes
Query cmp001 Integer Recommended Did the subject complete the study?
0;1
0=No; 1=Yes eoscomp, subsum_all_complete
Query cmp003 Integer Recommended Reason for early termination (Use codes below. Select one, then describe in Q4.)
1::26;-9
1=Withdrew consent; 2=Medical reason (AE, abnormal lab, intercurrent illness, etc.); 3=Disease progression; 4=Non-compliance with protocol or treatment; 5=Subject requires prohibited medication; 6=Termination of study by sponsor; 7=Subject terminated at discretion of the investigator or sponsor; 8=Other; 9=Death; 10=Protocol violation; 11=Lost to follow up; 12=CGI-I>5; 13=Screen Failure; 15=Other; -9=Unknown; 14=Non compliance with study drug; 16=Dissatisfied with treatment setting; 17=Experiencing unsatisfactory side effects; 18 = Subject ineligible; 19= Study too burdensome; 20= Dissatisfied with clinical response to treatment; 21= Unable to follow procedures, visit schedule, etc.; 22=Significant adverse event; 23=Participant uncooperative; 24 = Participant request; 25=Provider/Family request; 26=Did not continue to meet study criteria eosreas
cmp004 String 500 Recommended Describe reason for early termination eosother
Query eff_fail Integer Recommended Efficacy Failure based on 3 Criteria (psychiatric hospitalization, deterioration on CGI scale, PANSS change PANSS_C) 0;1 0=No; 1=Yes
Query iefffail Integer Recommended Subject Indicator for efficacy failure (3 criteria) 0;1 0=Otherwise; 1=Subject had efficacy failure (4 criteria) at least once
Query time2 Integer Recommended Time Trial 2 0 :: 999
Query efffail2 Integer Recommended Efficacy Failure based on 4 Criteria (psychiatric hospitalization, deterioration on CGI scale, PANSS change PANSS_C, or RTDA3 value of '01=positive symptoms', '02= Negative symptoms', '03 = mood symptoms', '04= other efficacy/inadequate therapeutic effect 0;1 0=No; 1=Yes
Query ieffail2 Integer Recommended Subject Indicator for efficacy failure (4 criteria) 0;1 0=Otherwise; 1=Subject had efficacy failure (4 criteria) at least once
Query time_ef2 Integer Recommended Time To Efficacy Failure (4 criteria), In Days 0::260
Query site_p String 5 Recommended Pseudo Site: Pooled According To Size
Query site_pp String 5 Recommended Pseudo Site: Pooled According to Size and Ethnicity pp1;pp2;pp3;pp4;pp5;pp6
Query itt Integer Recommended Intent-To-Treat Population 0;1 0=Not in Intent-to-treat population; 1=In intent-to-treat population
Query ee Integer Recommended Efficacy Evaluable Population 0;1 0=Not in Efficacy Evaluable population; 1=In Efficacy Evaluable population
Query pp Integer Recommended Per Protocol Population 0;1 0=Not in Per Protocol population; 1=In Per Protocol population
Query version_form String 121 Recommended Form used/assessment name vers
Query daysrz Integer Recommended days since randomization days
Query fseqno Integer Recommended Sequence Number 0::999 The FSEQNO variable in the ADJ form has a special interpretation compared to other forms. For example, ADJ FSEQNO of '1' can be thought of as being '001', FSEQNO of '2' can be thought of as being '002', and FSEQNO of '3' can be thought of as being '003'. The first digit of FSEQNO relates to the corresponding ENF sequence number at that visit and the third digit relates to the specific adjudicator who completed the adjudication form.
Query phase Integer Recommended Phase 9 =follow up
Query enddy_2 Integer Recommended Number of days from study baseline to end date of phase 2 fupdate
Query eos01 Integer Recommended Did the patient complete the study? (e.g.:attended all visits up to week 36) 0;1 0=No; 1=Yes fhx10a
Query eos06 Integer Recommended Day Signed Number of days from study baseline to date of signed End of Study form fhx10b
Query eos04d Integer Recommended Day of patient death: Number of days from study baseline to date of death
Query completed Integer Recommended Checks if completed 0::3 0=No; 1=Yes; 2=Yes, lost; 3=Unverified
tcdate Date Recommended Date of study treatment completion cmp002
Query possvisit Integer Recommended Possible number of visits
Query trtexcod Integer Recommended Treatment Exit Code 1;2;3;4;5;6;7;8;9;10;11;12;13 1=End of Study � Completed ALL Months of Study Treatment; 2=Patient decision � Lack of Efficacy; 3=Patient decision � Side Effects; 4=Patient decision � Refusal of Study Treatment � Part of Illness; 5=Patient decision � Refusal of Study Treatment � No Further Reason; 6=Patient decision � Wants Different Treatment or Treatment Elsewhere; 7=Unwilling/Unable to Comply with Study Treatment Demands; 8=Doctor decision � Lack of Efficacy; 9=Doctor decision � Side Effects; 10=Intervening Illness or Treatment; 11=Moved or Other Administrative Reason; 12=Lost to Follow-Up � No Further Reason; 13=Deceased
Query trtexday Integer Recommended Treatment Exit Days from Visit 1
Query stexcod Integer Recommended Study Exit Code 21;22;23;24;25;26;27 21=End of Study � Completed ALL Months of Assessment; 22=Lost to Follow-Up; 23=Patient Refused to Continue in Treatment and Study; 24=Patient Refused to Continue in Study; 25=Intervening Illness Interferes w/ Continuing; 26=Moved or Other Administrative; 27=Deceased
Query stexday Integer Recommended Study Exit Days from Visit 1
Query intrt Integer Recommended Treatment Status Code 0::2 0=Baseline; 1=In Treatment; 2=In Follow-up
Query trtgrp_p Integer Recommended Treatment Group 1;2 1=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
Query days_visit1 Integer Recommended Days from Visit 1 dav1dhs
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
dthdate String 30 Recommended Date of death eosdthdt
lstalvdt Date Recommended Date subject was last known to be alive eosalvdt
Query aef001 Integer Recommended Adverse Event number -9=unknown eosaeref
icfwddt Date Recommended Date subject withdrew consent eoswthdt
Query eosunbl String 2 Recommended Was the subjects treatment assignment unblinded? Y;N Y=Yes; N=No
eosrunbl String 200 Recommended Reason for unblinding
Query subsum_mri Integer Recommended Did the participant have the MRI scan indicated in the protocol? 0;1 0=No; 1=Yes
Query subsum_socog_test Integer Recommended Did the participant have the social cognition and neuropsychological assessments completed as indicated in the protocol? 0;1 0=No; 1=Yes
Query ayen Integer Recommended Has the subject had any adverse events during this study? 0;1;-9 0 = No; 1 = Yes; -9 = Did not inquire subsum_any_ae
Query ae String 250 Recommended Adverse event Description subsum_ae_notes
comments String 4,000 Recommended Comments about assessment subsum_notes
doa_futdt String 20 Recommended Future date entered (Assessment)
dode String 10 Recommended Date of Data Entry subsum_dode
dode_futdt String 20 Recommended Future date entered (Data Entry) subsum_dode_futdt
Query form_completed Integer Recommended Was the form completed? 1::4 1=Yes; 2=No; 3=Unverified; 4 = N/A-Not in age range subsum_form_completed
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 subsum_explain
other_reason_nc String 100 Recommended Other reason form was not completed subsum_other_reason_nc
Query assessment_complete Integer Recommended Complete? 0::2 0=Incomplete; 1=Unverified; 2=Complete participant_checklist_complete
Query stdor7 Integer Recommended Dropout-other reason 1;0 1 = Yes; 0=No
Query stdor7_s String 255 Recommended Stage V: Dropout-other reason, spec.
stdor3_s String 100 Recommended Stage V: Dropout-consent withdrawn, sp.
Query stdor3 Integer Recommended Dropout-consent withdrawn 1;0 1 = Yes; 0-No
Query termin_day Integer Recommended Days since baseline that clinic officially terminated the subject
Query eterm_03 Integer Recommended Lost to follow up 0;1 0=No; 1=Yes
Query aescode Integer Recommended Staff code number of person completing this form
Query hardcode String 1,200 Recommended Significant Protocol Violation Textual description of the protocol violation
Query cmp004_screen Integer Recommended Was the subject a screen failure 0;1 0=No; 1=Yes
Query failreas Integer Recommended Reason for Screen Failure 1::16 1=Patient did not want to change current typical antipsychitic med; 2 = Patient did not want to change current atypical antipsychitic med; 3 = Patient did not meet inclusion or exclusion criteria; 4 = Patient not able to make informed consent; 5 = Patient refusal - other reason; 6 = Other; 7=NA; 8=Did not meet diagnostic criteria; 9= Clinical or unstable medical disorder; 10= Moderate or severe substance use;11 =Pregnant, breastfeeding or planning on becoming pregnant; 12=Currently taking broccoli supplement; 13 = Substance- or medically-induced mood symptoms; 14 = Celiac disease; 15 = Receipt of ECT within 30 days prior to Visit 1/Baseline; 16 = Participation in any drug trial in the 30 days prior to Visit 1/Baseline
cmp005_desc String 100 Recommended Other reason for screen failure
cmp005_date Date Recommended Date of screen failure
Query cmp003_date String 30 Recommended Date of early withdrawal
cmp003_time String 25 Recommended The participant was withdrawn prematurely from the study closest to visit/week
Query cmp006_et Integer Recommended Did the subject complete an Early Termination Visit 0;1 0=No; 1=Yes
cmp006_date Date Recommended Date of Early Termination Visit
Query phasescompleted String 15 Recommended Phase completed
Query lastvisit Integer Recommended This variable indicates whether the assessment was the last for the subject. For the acute phase, this is generally at week 12, but the last weekly visit will vary for early terminators. 0;1 0 = no; 1 = yes
Query term_consent_withdraw String 200 Recommended Participant Withdrew Consent - Please Specify
Query reason_for_rejection String 250 Recommended Please, specify reason for rejection or disapproval:
Query ptaef Integer Recommended AEF Completed? 0;1 (Yes=1; No=0)
Query trmssrsn String 250 Recommended Termination of participation by sponsor Reason
Query iecsig Integer Recommended Investigator signature on form. 0;1 0=No; 1= Yes
Query sigd1 Integer Recommended Physician/PI signature date (days since randomization)
Query enroll_not Integer Recommended Reason for not being in study 1::7 1= Not eligible;2= Not interested;3= Withdrawn -- Participant choice;4= Withdrawn -- Investigator choice;5= Withdrawn -- Lost to follow-up;6= Death; 7 = Withdrawn -- Patient/Family choice
Query phase_1 Integer Recommended scp rcp phase 1 1::6;-7 1=Acute; 2=Continuation; 3=Maintenance; 4=Termination; 5 = Extension; 6 = Discontinuation/Tapering -7=Refused
Query argcont Integer Recommended Has the subject agreed to continue to come in for scheduled visits even thought he/she is no longer following the study protocol? 0;1 0 = No; 1 = Yes
ptdrief1 String 400 Recommended How do you think the treatment sessions worked?
Query ptdrief2 Integer Recommended During treatment sessions, did you notice a pattern of when the music would start and stop? 0;1 0 = No; 1 = Yes
tms7 String 20 Recommended If yes, session 2 start time
tms16 String 20 Recommended If yes, session 2 end time
tms14 String 20 Recommended Start time of MRI (after session 2)
tms9 Integer Recommended Was session 3 completed? 1 = yes, 0=no
tms10 Date Recommended If yes, session 3 date
tms11 String 20 Recommended If yes, session 3 start time
tms17 String 20 Recommended If yes, session 3 end time
tms15 String 20 Recommended Start time of MRI (after session 3)
tms1 Integer Recommended Was session 1 completed? 1 = yes, 0=no
tms2 Date Recommended If yes, session 1 date
tms3 String 20 Recommended If yes, session 1 start time
tms12 String 20 Recommended If yes, session 1 end time
tms13 String 20 Recommended Start time of MRI (after session 1)
tms5 Integer Recommended Was session 2 completed? 1 = yes, 0=no
tms6 Date Recommended If yes, session 2 date
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.