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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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Dose Compliance Variables

1,881 Shared Subjects

Clinical Trials: Dose, compliance variables
Clinical Assessments
Summary
05/07/2014
dosecomp01
05/07/2014
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 CATIEID
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 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
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
Query medad01 String 10 Recommended What Phase was the patient in at the beginning 1 or 1A; 1B; 2; 3; 4 4=Open-Choice madh01
Query medad03 Float Recommended Proportion of capsules taken A calculation done by the site of the proportion of prescribed capsules since the previous visit that were taken, based on pill count in the returned bottle. (This is a pill count estimate of compliance since the previous visit, and requires the patient to return the bottle) This field is only applicable to double-blind treatments (Phase 1/1a, Phase 2 except for Clozapine)
Query medad06 Integer Recommended Number of capsules prescribed per day Prescribed dose since the previous visit. Patients could be prescribed between 1 and 4 double-blind capsules per day. This field is only applicable to double-blind treatment visits (Phase 1/1a, Phase 2 except for Clozapine)
Query medad07 Integer Recommended For Phase 2 open-label Clozapine, day This field is only applicable for Phase 2 visits for patients on Clozapine. Prescribed dose since the previous visit (mg).
Query msa04 Integer Recommended has patient taken medication using dosage frequency by QTONE? 0;1 0=No; 1=Yes; Indicates if patients were instructed to take medication using the randomized dosing regimen, which is either QD - once per day or BID - twice per day. This field is only applicable to double-blind treatment visits (Phase 1/1a, Phase 2 except for Clozapine)
Query msa04b Integer Recommended if no, the patient is taking the study medication 1;2 1= QD; 2= BID. This field is only applicable to double-blind treatment visits (Phase 1/1a, Phase 2 except for Clozapine)
Query medad08 Integer Recommended Medication 1 1::8 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone;5= Perphenazine; 6=Clozapine; 7=Fluephenazine-D; 8=Aripiprazole
Query medad10 Float Recommended Prescribed dose since last visit This field is only applicable to Phase 3 open-label visits
Query medad11 Integer Recommended Medication 2 1::8 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone;5= Perphenazine; 6=Clozapine; 7=Fluephenazine-D; 8=Aripiprazole
Query medad13 Float Recommended Prescribed dose since last visit This field is only applicable to Phase 3 open-label visits
Query medad14 Integer Recommended Clinical Global Judgment of Medication A 1::4 1=Always/Almost always [76-100% of the time]; 2=Usually [51-75% of the time]; 3=Sometimes [26-50% of the time]; 4=Never/Almost never [0-25% of the time]
Query capsules Float Recommended Number of Capsules Prescribed/Day Since Last Visit Number of capsules prescribed/day since the last visit=MEDAD06
Query dose1 Float Recommended Prescribed Daily Dose in P1 (mg) # of capsules prescribed per day since the last visit multiplied by the capsule strength of treatment. Capsule strength is as follows: OLZ: 7.5 mg; QUET: 200 mg; RISP: 1.5 mg; PER: 8 mg; ZIP: 40 mg. Note: This is the dose in mg. This field does not contain the actual treatment assignment. Treatment assignments are not contained in this file - see file KEYVARS.
Query dose2 Float Recommended Prescribed Daily Dose in P2 (mg) # of capsules prescribed per day since the last visit multiplied by the capsule strength of treatment. Capsule strength is as follows: OLZ: 7.5 mg; QUET: 200 mg; RISP: 1.5 mg; ZIP: 40 mg. CLOZ: as reported in variable MEDAD07. Note: This is the dose in mg. This field does not contain the actual treatment assignment. Treatment assignments are not contained in this file - see file KEYVARS.
Query dose3 Float Recommended Prescribed Daily Dose in P3 (mg) As reported in variables MEDAD10 (first Phase 3 treatment) and MEDAD13 (second Phase 3 treatment). Missing if patient was receiving Dual treatment.
Query presreg1 Integer Recommended P1 Prescribed Dosing Regimen 1;2 1= Once a Day (BID); 2= Twice a Day (QD). This is usually equal to the randomized dosing regimen in Phase 1/1a (see file KEYVARS for randomized dosing regimen variable), but if a patient was ever switched to a different regimen, (per MSA04 and MSA04B), then this takes the value of the regimen the patient was switched to. Value is stored on the first record per patient
Query presreg2 Integer Recommended P2 Prescribed Dosing Regimen 1::3 1= Once a Day (BID); 2= Twice a Day (QD); 3=none (for clozapine). This is usually equal to the randomized dosing regimen in Phase 2 (see file KEYVARS for randomized dosing regimen variable), but if a patient was ever switched to a different regimen, (per MSA04 and MSA04B), then this takes the value of the regimen the patient was switched to. Value is stored on the first record per patient
Query avgcaps1 Float Recommended Average number of capsules prescribed/day across phase 1/1A (mg) Value is stored on the first record per patient
Query avgdose1 Float Recommended Average prescribed daily dose across phase 1/1a (mg) Value is stored on the first record per patient
Query moddose1 Float Recommended Modal prescribed daily dose across phase 1/1a (mg) Value is stored on the first record per patient
Query catcaps1 Integer Recommended Average Number of Capsiles Prescribed Across P1 (Cat) 1::4 categorized version of AVGCAPS1 1= 1 capsule; 2= 2 capsules; 3= 3 capsules; 4= 4 capsules. Value is stored on the first record per patient
Query avgcaps2 Float Recommended Average Number of Capsiles Prescribed Across P2 Average number of capsules prescribed/day across phase 2. Value is stored on the first record per patient
Query avgdose2 Float Recommended Average Prescribed Dose Across P2 (mg) Average prescribed daily dose across phase 2 Value is stored on the first record per patient
Query moddose2 Float Recommended Modal Prescribed Dose Across P2 (mg) Modal prescribed daily dose across phase 2 Value is stored on the first record per patient
Query catcaps2 Integer Recommended Average Number of Capsiles Prescribed Across P2 (Cat) 1::5 categorized version of AVGCAPS2 1= 1 capsule; 2= 2 capsules; 3= 3 capsules; 4= 4 capsules; 5= 5 capsules. Value is stored on the first record per patient
Query avgdose3 Float Recommended Average Prescribed Dose Across P3(mg) Average prescribed daily dose across phase 3 Not defined for patients on Dual medication in P3 Value is stored on the first record per patient
Query moddose3 Float Recommended Modal Prescribed Dose Across P3 (mg) Modal prescribed daily dose across phase 3. Not defined for patients on Dual medication in P3 Value is stored on the first record per patient
Query max1 Integer Recommended Flag: Max # Capsules Prescribed in P1 0;1 1=Yes at one record which has the maximum value of CAPSULES in phase 1/1a
Query max2 Integer Recommended Flag: Max # Capsules Prescribed in P2 0;1 1=Yes at one record which has the maximum value of CAPSULES (or Clozapine dose) in phase 2
Query max3 Integer Recommended Flag: Max Dose Prescribed in P3 0;1 1=Yes at one record which has the maximum dose in phase 3. Not defined for patients on Dual medication in P3
Query madh12a Integer Recommended Num of std caps prscrbd snce vis hi
Query madh12b Integer Recommended Num of std caps prscrbd snce vis low
Query madh13 Float Recommended For Phase 3, open- label daily dose p
Query treat_1 Integer Recommended Treatment for Phase 1 1::8 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine;7= Citalopram; 8=Placebo
Query treat2 Integer Recommended Treatment for Phase 2E/2T 1::8 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine; 7= Citalopram; 8=Placebo
Query treat_3 Integer Recommended Treatment for Phase 3 (Combined) 1::9 Contains treatment assigned in Phase 3. If patient was only assigned one drug in this phase, the drug name is listed. If a patient was assigned 2 drugs in Phase 3, this variable takes the value of Dual.1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine; 7=Aripiprazole; 8=Fluphenazine; 9=Dual
Query dur_1 Float Recommended Duration in Phase 1 (weeks)
Query dur_2 Float Recommended Duration in Phase 2 (weeks)
Query dur_3 Float Recommended Duration in Phase 3 (weeks)
Query lowdose Float Recommended # Low Dose Caps * Treatment Dose # of low dose capsules prescribed per day multiplied by the capsule strength of treatment OLZ: 2.5 mg QUET: 25 mg RISP: 0.5 mg CIT: 10 mg
Query highdose Integer Recommended # High Dose Caps * Treatment Dose # of high dose capsules prescribed per day multiplied by the capsule strength of treatment OLZ: 5 mg QUET: 50 mg RISP: 1 mg CIT: 20 mg
Query dose Float Recommended Prescribed Dose in Phase (mg)
Query first_d Integer Recommended Flag: 1st Non-Miss Prescribed Dose in Ph 1 1=Yes for all records meeting this criteria
Query last_d Integer Recommended Flag: Last Prescribed Dose in Phase 1 1=Yes for all records meeting this criteria
Query first_c Integer Recommended Flag: First Caps Prscbd in HighDose in P 1 1=Yes for all records meeting this criteria
Query last_c Integer Recommended Flag: Last Caps Prscbd in HighDose in Ph 1 1=Yes for all records meeting this criteria
Query first_v Integer Recommended Flag: First Visit in Phase 1 1=Yes for all records meeting this criteria
Query last_v Integer Recommended Flag: Last Visit in Phase 1 1=Yes for all records meeting this criteria
Query dse_adj1 Integer Recommended Patient Adjusted (Inc) Dose (#Caps): P1 0;1 1=Yes if patient increased the number of capsules in phase; missing otherwise
Query dse_adj2 Integer Recommended Patient Adjusted (Inc) Dose (#Caps): P2 0;1 1=Yes if patient increased the number of capsules in phase; missing otherwise
Query compl_1 Float Recommended Treatment Compliance (%) Across All Visits Compliance in Phase 1
Query compl_1c Integer Recommended Treatment Compliance (Categorized) Across 1;2;3 1 = < 76%; 2 = 76-100%; 3 = > 100%
Query compl_2 Float Recommended Treatment Compliance (%) Across All Visits Compliance in Phase 2
Query compl_2c Integer Recommended Treatment Compliance (Categorized) Across 1;2;3 1 = < 76%; 2 = 76-100%; 3 = > 100%
Query compl_3 Float Recommended Treatment Compliance (%) Across All Visits Compliance in Phase 3
Query compl_3c Integer Recommended Treatment Compliance (Categorized) Across 1 = < 76%; 2 = 76-100%; 3 = > 100%
Query b1_day Integer Recommended Baseline Day - Phase 1/1A Number of days from study baseline to first day of the phase Based on visit dates
Query b2_day Integer Recommended Baseline Day - Phase 2 Number of days from study baseline to first day of the phase Based on visit dates
Query b3_day Integer Recommended Baseline Day - Phase 3 Number of days from study baseline to first day of the phase Based on visit dates
Query boc_day Integer Recommended Baseline Visit Day- Open Choice Phase Number of days from study baseline to start date of phase
Query e1_day Integer Recommended Day Discontinued from Phase 1/1A Number of days from study baseline to date of phase discontinuation Based on visit dates
Query e2_day Integer Recommended Day Discontinued from Phase 2 Number of days from study baseline to date of phase discontinuation Based on visit dates
Query e3_day Integer Recommended Day Discontinued from Phase 3 Number of days from study baseline to date of phase discontinuation Based on visit dates
Query eoc_day Integer Recommended Visit Day Discontinued from Open Choice Number of days from study baseline to end date of phase
Query es_day Integer Recommended Day Discontinued from Study Number of days from study baseline to date of study discontinuation (excluding follow-up phase) Based on visit dates
Query b3_cgic Integer Recommended Phase 3 Baseline CGIC
Query b3_resp Integer Recommended Phase 3 Baseline CGIC Response
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.