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This is a U.S. Government computer system, which may be accessed and used only for authorized Government business by authorized personnel. Unauthorized access or use of this computer system may subject violators to criminal, civil, and/or administrative action. All information on this computer system may be intercepted, recorded, read, copied, and disclosed by and to authorized personnel for official purposes, including criminal investigations. Such information includes sensitive data encrypted to comply with confidentiality and privacy requirements. Access or use of this computer system by any person, whether authorized or unauthorized, constitutes consent to these terms. There is no right of privacy in this system.

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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).

When combining other filters with the GUID filter, please note the GUID filter should be added last. Otherwise, preselected data may be lost. For example, a predefined filter from Featured Datasets may select a subset of data available for a subject. When combined with a GUID filter for the same subject, the filter cart will contain all data available from that subject, data structure, and dataset; this may be more data than was selected in the predefined filter for that subject. Again, you should add the GUID Filter as the last filter to your cart. This ensures 'AND' logic between filters and will limit results to the subjects, data structures, and datasets already included in your filter cart.

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 filter 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

  • What is a Filter Cart?
    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.
  • What do I do after filters are added to the Filter Cart?
    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.
  • Are there limitations on the amount of data a user can download?

    NDA limits the rate at which individual users can transfer data out of Amazon Web Services (AWS) S3 Object storage to non-AWS internet addresses. All users have a download limit of 20 Terabytes. This limit applies to the volume of data an individual user can transfer within a 30-day window. Only downloads to non-AWS internet addresses will be counted against the limit.

  • How does Filter Cart Boolean logic work?

    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.

    When combining other filters with the GUID filter, please note the GUID filter should be added last. Otherwise, preselected data may be lost. For example, a predefined filter from Featured Datasets may select a subset of data available for a subject. When combined with a GUID filter for the same subject, the filter cart will contain all data available from that subject, data structure, and dataset; this may be more data than was selected in the predefined filter for that subject. Again, you should add the GUID Filter as the last filter to your cart. This ensures 'AND' logic between filters and will limit results to the subjects, data structures, and datasets already included in your filter cart.

Glossary

  • Workspace
    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.
  • Filter Cart
    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 adds data using an AND condition. The opportunity to further refine data to determine what will be downloaded or sent to a miNDAR is available on the Data Packaging Page, the next step after the Filter Cart. Subsequent access to data is restricted by User Permission or Privilege; however Filter Cart use is not.
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Anticonvulsant Drug Level

242 Shared Subjects

N/A
Clinical Assessments
Treatment
04/13/2015
adl01
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 randid
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 :: 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.
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
Query study String 100 Recommended Study; The code for each individual study studyid
Query site String 101 Recommended Site Study Site siteid
Query visit String 60 Recommended Visit name int1, interval
Query completed Integer Recommended Checks if completed 0::3 0=No; 1=Yes; 2=Yes, lost; 3=Unverified formcomp, frmcomp
Query subtrial_name Integer Recommended Name of subtrial 1::3 1=Crossover; 2=Guanfacine; 3= Open Label MPH
Query adl_q01 Integer Recommended Date of blood draw in days from the randomization date (ADL_Q01 = Date of blood draw - randomization date) drawdate
Query drawtime String 20 Recommended time of blood draw adl_q02
Query adl_q03 Integer Recommended Date of last study med taken in days from the randomization date (ADL_Q03 = Date of last dose of study medication - randomization date) -888=NA datemed
Query adl_q04 String 20 Recommended Time of last study med -888=NA medtime
Query adl_q05 Integer Recommended Date of last anticonvulsant taken in days from the randomization date (ADL_Q05 = Date of last dose of anticonvulsant - randomization date) dateanti
Query adl_q06 String 20 Recommended Time of last anticonvulsant antitime
Query adl_q07a Integer Recommended Phenytoin test ordered 1;2 1=Yes 2=No phenytn
Query adl_q07b Integer Recommended Carbamazepine test ordered 1;2 1=Yes 2=No carbamaz
Query adl_q07c Integer Recommended Valproate test ordered 1;2 1=Yes 2=No valproat
Query adl_q07d Integer Recommended Lamotrigine test ordered 1;2 1=Yes 2=No lamotrig
Query adl_q07e Integer Recommended Gabapentin test ordered 1;2 1=Yes 2=No gabapent
Query adl_q07f Integer Recommended Other1 test ordered 1;2 1=Yes 2=No other1
Query adlq07fs String 50 Recommended Other1 test specify spec1
Query adl_q07g Integer Recommended Other2 test ordered 1;2 1=Yes 2=No other2
adlq07gs String 50 Recommended Other2 test specify spec2
Query daysrz Integer Recommended days since randomization studyday, visitdt
Query blooddraw Integer Recommended Was blood drawn for tests? 1;2 1= Yes 2= No 1 Or 2 Or Is Null blood
Query ci_enrolled Integer Recommended Participant enrolled 0;1 0=No; 1=Yes enrolled
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
Query wk_seizure_med Integer Recommended Seizure. Medication Used (Details in next section) 0;1 No = 0; Yes = 1;
Query other_reason_nc String 100 Recommended Other reason form was not completed
Query txrisp Integer Recommended treatment risperidone 1;0;-7 0=No; 1=Yes;-7=Refused
Query arioral Integer Recommended Code indicating aripiprazole oral Code=1
Query carbacs Integer Recommended carbamazepine clinic signif 0;1;-7 0=No; 1=Yes; -7=Refused
Query blfnrvallev Float Recommended Non-randomized medication - Valproate level ug/mL
Query iaoth Integer Recommended other action taken 0;1;-4;-5;-6;-7;-8 0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
aef008a String 200 Recommended If other action taken, specify
Query log011 String 50 Recommended Patients chart (e.g., hard copy, electronic, or other medical record) reviewed? 0;1;-888;-999 0=No; 1=Yes; -888=Not Applicable; -999=Missing;
Query valpcs Integer Recommended valproate clinically signif 0;1;-7 0=No; 1=Yes; -7=Refused
Query carbrst Float Recommended Lab test result: Carbamazepine ug/ml
Query lamotrst Float Recommended Lab test result: Lamotrigine ug/ml
Query lamotsg Integer Recommended Lamotrigine: clinically significant 0;1;-7 0=No; 1=Yes; -7=Refused
Query oth1rst Float Recommended Lab test result: Other 1: ug/ml
Query other1sg Integer Recommended Lab test result: Other 1: significant change? 0;1; -7 0=No; 1=Yes; -7=Refused
Query sigp1 Integer Recommended Physician signature present 0;1 0 = No; 1 = Yes
Query sigd1 Integer Recommended Physician/PI signature date (days since randomization)
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
Query study_drug_team String 30 Recommended Study drug Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA
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.