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The filters you have selected from various query interfaces will be stored here, in the 'Filter Cart'. The database will be queried using filters added to your 'Filter Cart', when multiple filters are defined, each will be executed using 'AND' logic, so with each filter that is applied the result set gets smaller.

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Description
Value Range
Notes
Data Structures with shared data
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Clinical Trials: Randomization

rdm

01

Clinical Trials: Randomization

Download Definition as
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Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*guid
src_subject_idString20RequiredSubject ID how it's defined in lab/projectSUBJECT, bid, id, randid, record_id, rsubjid, subject_id
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired fieldRVDATE, intvdate
interview_ageIntegerRequiredAge in months at the time of the interview/test/sampling/imaging.0 :: 1260Age 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.dema1, intvage
genderString20RequiredSex of the subjectM;FM = Male; F = Femaledema2
aescodeIntegerRecommendedStaff code number of person completing this formRDMCODE
visitString50RecommendedVisit nameCharacter description of each type of visitint1
bafinfoIntegerRecommendedCheck if the Assessment was not done.0;10=No; 1=YesRDMINFO
mtincIntegerRecommendedDoes the subject continue to meet the inclusion exclusion criteria?0;1; -90=No; 1=Yes; -9=unknownran001
elrdmIntegerRecommendedIs the subject eligible for randomization?rdma3
rdmdateDateRecommendedDate of Randomizationran003
prjdate6DateRecommended6 week projection date
prjdate12DateRecommended12 week projection date
hloconditionIntegerRecommendedWhat condition is the patient randomized to?0;10=Control; 1=Posit ScienceCONDITION
nrdmrsnIntegerRecommendedPrimary reason not randomized0::51=Failed to meet inclusion criteria; 2=Withdrew consent; 3=Medical reason (AE, illness, etc); 4=Non-compliance with protocol treatment; 5=Subject requires prohibited medication; 0=Otherran005
nrdmspcString50RecommendedSpecify other reason not randomizedran006
siteString100RecommendedSiteStudy Sitesiteid
ran001aIntegerRecommendedWas this subject a re-screen?0;10=No; 1=Yes
ran001bIntegerRecommendedWere all re-screen assessments performed?0;10=No; 1=Yes
ran002IntegerRecommendedWas the subject randomized?0::3; -90=No; 1=Yes; -9=unknown; 2=No meds; 3=No community careran_q1b
ran004String10RecommendedRandomization number/codingcohort
visitidIntegerRecommendedMetaTrial Visit IDSystem variable: unique code for each type of visit -use to merge files
fseqnoIntegerRecommendedSequence Number0::999The 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.
rdma1IntegerRecommendedDoes the patient still give consent to participate in the study?0;10=No; 1=Yes
rdma2IntegerRecommendedIs the patient still considered eligible for study participation?0;10=No; 1=Yes
rdma4IntegerRecommendedDo you want to randomize this patient?0;10=No; 1=Yes
rdma6IntegerRecommendedDo you need a bottle code for the oral trial?0;10=No; 1=Yes
versionFloatRecommendedVersion/code of assessment
visdayIntegerRecommendedNumber of days from study baseline to date of visit
version_formString100RecommendedForm used
daysrzIntegerRecommendeddays since randomizationdate, visitdt
studyString100RecommendedStudystudyid
completedIntegerRecommendedChecks if form is completed0::20=No; 1=Yes; 2=Yes, lostformcomp
subtrial_nameIntegerRecommendedName of subtrial1::31=Crossover; 2=Guanfacine; 3= Open Label MPH
ran_q1IntegerRecommendedTolerate 4 lowest Doses0;10=No; 1=Yes
ran_q1aIntegerRecommendedTolerate highest dose0;10=No; 1=Yes
ran_q4IntegerRecommendedPrimary reason not randomized1::101 = Toxicity or side effects related to study medication; 2 = Medical reason unrelated to study medication; 3 = Termination by principal investigator because of non medical reasons; 4 = Failed to return to clinic; 5 = Declined study participation; 6 = Moved from area (current or pending); 7 = Death; 8 = Subject no longer eligible to participate; 9 = School unable/no longer willing to participate; 10 = Other
enrl_ordIntegerRecommendedOrder of Enrollment - The first subject enrolled in the Guanfacine Trial (i.e., the earliest enrollment date) has ENRL_ORD = 1, the second subject enrolled has ENRL_ORD = 2, the third has ENRL_ORD = 3, etc. Subjects enrolled on the same day are given the same number.Derived variable, not on CRF
ranq5IntegerRecommendedReason not randomized1::7;-91=Failed to meet inclusion or exclusion criteria; 2=Declined study participation/Withdrew consent; 3=Failed to return to clinic; 4=Moved from area; 5=Incarceration; 6=Death; 7=Other; -9=Unknown
armIntegerRecommendedAssigned Randomization Arm1::31=Escitalopram plus Orange capsule-Lexapro; 2=Bupropion-SR plus Blue capsule-Wellbutrin; 3=Venlafaxine XR plus Green capsule-Effexor
vis_typeIntegerRecommendedVisit type0::21=Phone; 0=doctor's office; 2=No, not phone interviewphone
ran004aIntegerRecommendedTreatment Group1;2;-91=start treatment with ketamine; 2= start treatment with saline; -9 =unknownq4a
inelgsString250RecommendedIneligible reasonrdma2a
iec16IntegerRecommendedEligibility status1::31=Eligible; 2= Ineligible; 3=Pendingrdma3a
iec003aIntegerRecommendedIs the subject eligible to participate in the study?
0;1;-9
0=No; 1=Yes; -9=Unknownrndqual
trtarmString200RecommendedTreatment arm
datetimeString25RecommendedDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYY and __:__sitedtm
resubmitIntegerRecommendedRandomization error- resubmit0;1; -90=No; 1=Yes; -9=Unknown
ad_exc11IntegerRecommendedCurrent use of antidepressants or anticonvulsants0;10=No; 1=Yes
treatment_nameString200Recommendedtreatment name
randomizationIntegerRecommendedRandomization Field2;32=Blue; 3=White
ca6_1IntegerRecommendedChronic depression0;10=No; 1=Yes
bdi_stwIntegerRecommendedSuicidal thoughts or wishes0;1;2;3;-7; -90=I don't have any thoughts of killing myself; 1= I have thoughts of killing myself, but I would not carry them out; 2=I would like to kill myself; 3=I would kill myself if I had the chance"; -7=Refused; -9=incomplete
psmd1String250RecommendedPsych med code 1
refothersString50RecommendedReferral source: specify
med_groupIntegerRecommendedRandomly Assigned Medication Group0;1(0=Changed to Second SSRI, 1=Changed to VENLAFAXINE)
cbt_groupIntegerRecommendedRandomly Assigned to Clinical Behavior Therapy?0;1(0=No, 1=Yes)
ssricatString50RecommendedRandomly Assigned SSRI
cameonString50RecommendedCurrent SSRI
noparoxIntegerRecommendedConstrain paroxetine?11 = YES for all patients; YES for all patients became active when study stopped using paroxetine.
reffluIntegerRecommendedDid patient refuse fluoxetine?(Prozac)0;10 = No; 1 = Yes
refcitIntegerRecommendedDid patient refuse citalopram?(Celexa)0;10 = No; 1 = Yes
refparIntegerRecommendedDid patient refuse paroxetine?0;10 = No; 1 = Yes
comanxIntegerRecommendedCOMORBID ANXIETY0;10=No; 1=Yes
rnd_5IntegerRecommendedRandomized provider number
litheverIntegerRecommendedever taken lithium0;1;-70=No; 1=Yes; -7=Refused
weekFloatRecommendedWeek in level/study99=week 10-week 14
visnumFloatRecommendedNumeric 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
iecsigIntegerRecommendedInvestigator signature on form.0;10=No; 1= Yes
lab020DateRecommendedDate of PI/clinician signature
sigd1IntegerRecommendedPhysician/PI signature date (days since randomization)
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.

Distribution for DataStructure: rdm01 and Element:
Chart Help

Filters enable researchers to view the data shared in NDA before applying for access or for selecting specific data for download or NDA Study assignment. For those with access to NDA shared data, you may select specific values to be included by selecting an individual bar chart item or by selecting a range of values (e.g. interview_age) using the "Add Range" button. Note that not all elements have appropriately distinct values like comments and subjectkey and are not available for filtering. Additionally, item level detail is not always provided by the research community as indicated by the number of null values given.

Filters for multiple data elements within a structure are supported. Selections across multiple data structures will be supported in a future version of NDA.