Job Types for Study Administrators

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Autocoding and Suggestions

Vault Coder runs the Autocoding and Suggestions job automatically. This job analyzes all Code Requests that are pending coding and attempts to autocode them and generate suggestions. The Autocoding and Suggestions job allows you to autocode a coding request or generate a suggestion if Vault has not already done so.

Job Options

There are no special configuration options for the Autocoding and Suggestions job.

Output

This job does not generate any output file.

Audit Trail Export

The Audit Trail Export job generates a CSV file containing the audit trail for each Casebook in a Study, including any deleted records, such as those removed by a retrospective amendment. This job also generates an additional CSV file to track deleted Subjects.

Job Options

The following configuration options are available for the Audit Trail Export job:

  • Date Range: You can choose to apply a date range to your Audit Trail Export.

  • User: You can choose to filter your exported audit trail to only include actions performed by a specific user.

Output

When the Audit Trail Export job finishes, you can download a ZIP file containing CSVs for each Casebook and the CSV for deleted Subjects. Extract the ZIP files contents and review the CSVs in your preferred editor.

Code Request Export

The Code Request Export job generates a CSV file that details all Code Requests for a Study. Organizations that use the Data Export job can combine this job’s output and a Data Export job’s SAS output to review study execution and coding data together. These files can be joined using key value pairs for Subject ID and Form Sequence or Item Group Sequence.

Job Options

The following configuration options are available for the Code Request Export job:

  • External Connection: You can choose to export your data to a configured FTP location, instead of downloading the files. To use this option, you must first create an FTP connection from EDC Tools > FTPs.

Output

When the Code Request Export job finishes, you can download a CSV file listing all Code Requests for a Study, including Study, Site, Form, and Code information for each Code Request.

Core Listing

The Core Listing job generates a simplified CSV for each Form included, listing the data collected for that Form.

Job Options

The following configuration options are available for the Core Listing job:

  • Forms: In the Forms tab, use the Arrow buttons to move Forms from Available Forms to Selected Forms. Forms in the Selected Forms section are included in the export. You must select at least one Form.

  • Sites: In the Sites tab, use the Arrow buttons to move Sites from Available Sites to Selected Sites. Sites in the Selected Sites section are included in the export. You must select at least one Site.

Output

When the Core Listing job finishes, you can download a ZIP file containing CSV files for each selected Form. Each form’s CSV lists data for each Subject in the selected Sites. The following information is included (as columns):

  • Study
  • Study Country
  • Site
  • Subject
  • Event Group
  • Event Group Sequence Number
  • Event
  • Form Casebook Version
  • Form
  • Form Sequence Number
  • Form Status
  • Form Creation Date
  • Form Submission Date
  • Form ILB Status*
  • Form ILB Reason
  • Item Group Sequence Number
  • DateTime of Last Data Change
  • Open Queries
  • Closed Queries
  • Form SDV Status
  • Form SDV DateTime
  • Form DMR Status
  • Form DMR DateTime
  • Form Frozen Status*
  • Form Frozen DateTime*
  • Form Locked Status*
  • Form Locked DateTime*
  • Form Signed Status*
  • Form Signed DateTime*
  • Core Listing as of {DateTime when the job was run}

Form CSVs also include a column for each Item on the Form, which lists the entered value, labeled with the item’s Label, Name, and the item’s Item Group. For example, an Item labeled “Procedure Time” (named PROC_TIME) in an Item Group named IG_PROC has the column header “Procedure Time (IG_PROC.PROC_TIME)”. For unit-type Items, Vault includes additional columns for the Value, Unit, Value Translated, and Unit Translated.

For repeating Forms and Item Groups, the CSV includes a row for each sequence of repetition.

If a Form is configured for coding, Vault includes additional columns detailing the coding status and any assigned code.

  • For WHODrug forms, Vault includes: Coding Status, Drug Code, Drug Name, Preferred Code, Preferred Name, ATC4 Code, ATC4, ATC3 Code, ATC3, ATC2 Code, AC2, ATC1 Code, ATC`, Dictionary Release, and Last Coded Date.
  • For MedDRA forms, Vault includes: Coding Status, LLT Code, LLT, PT Code, PT, HLT Code, HLT, HLGT Code, HLGT, SOC Code, SOC, Dictionary Release, and Last Coded Date.

*ILB is an abbreviation for Intentionally Left Blank.

*Vault only includes these Form status columns for Studies created prior to the 19R3 release (December 2019).

Data and Definition Export

The Data and Definition Export job (formerly known as the JReview job) exports a ZIP file of CSVs representing collected data in your Study.

Job Options

The following configuration options are available for the Data and Definition Export job:

  • Include Restricted Data: If you have the Restricted Data Access permission, you can select this checkbox to include data from restricted forms in your export.

Output

When the Data and Definition Export job is complete, you can download the ZIP file containing all Form CSVs. Extract the contents and view the exported data in your preferred file viewer.

Data Export

The Data Export job exports study execution data as a series of either CSV or SAS files, in a format determined in your study’s design.

Job Options

The following configuration options are available for the Data Export job:

  • View Set: Select a View Set to base your export on. View set availability depends on your vault’s configuration and your study design. Contact your Veeva Services representative for details.

  • Export File Type: You can export data as CSVs or as SAS files. Choose one.

  • External Connection: You can choose to export your data to a configured FTP location, instead of downloading the files. To use this option, you must first create an FTP connection from EDC Tools > FTPs.

Output

When the Data Export job is complete, you can download a ZIP file containing either CSVs or SAS files, depending on your selections. Extract the contents and view the exported data in your preferred file viewer.

Detail PDFs

The Detail PDFs job exports subject Casebooks as PDFs, including any entered data within those Casebooks. Optionally, this export can include query and audit trail information.

Job Options

The following configuration options are available for the Detail PDFs job:

  • Include Queries: Select this checkbox to include queries in your PDF.

  • Include Audit Trail: Select this checkbox to include the related audit trails in your PDF.

  • Scope: Select Export all sites to include all Sites for the Study, generating a closeout PDF. Select Select Sites to choose which Sites to include. If you chose Select sites, use the Arrow buttons to move Sites from Available to Selected. Sites in Selected are included in the PDF export.

Output

When the Detail PDFs job finishes, you can download a ZIP file containing a folder for each Site. Each of those site folders contains a Detail PDF for each subject Casebook at that Site.

Event Progress Listing

The Event Progress Listing job generates a list of all Events in the Study, with status details and operational data, as a CSV file.

Job Options

The following configuration options are available for the Event Progress Listing job:

  • Include Review Data: Users with the View SDV or View DMR permissions can choose to include SDV/DMR data in the listing.

  • Include Restricted Data: When this checkbox is selected, Vault includes data related to restricted Forms if the job is initiated by a user with the Restricted Data Access permission. The Restricted status rolls up to the Event level when all Forms in the Event are restricted.

Output

The Event Progress Listing job CSV includes the columns listed below. If your Study is using Data Model V1, the Event Signature Date, Freeze Date, and Lock Date columns will be blank in the CSV output.

Column Header Description
Study Study Name
Study Country Study Country Name
Site Site number
Subject Subject number
Subject Status Current Subject status
Event Group Label Event Group Label
Event Label Event Label
Event Group Sequence Number Event Group Sequence Number
Event Date Event Date entered
Event Status Event status (Planned, Blank, In Progress, Submitted, Did Not Occur)
Event Did Not Occur Indicates if the event was marked as Did Not Occur (Yes/No value)
Event Did Not Occur Reason Change Reason entered if the event was marked as Did Not Occur
Restricted Event Shows if the event is restricted or not (Yes/No value)
Early Planned Date The low date relative to study design plan and not considered out of window
Planned Date The date from study design the event was planned for
Late Planned Date The high date relative to study design plan and not considered out of window
Event Out of Window If the event is out of window (below Early, above Late), or if missing (and past late grace)
Days Out of Window If Out of Window, display the number of days out of window
SDV Plan The SDV plan assigned to subject at time of generation
Event Date SDV Shows whether or not the Event Date completed SDV (Yes/No value)
Event Date SDV Required Shows if SDV was required for the Event Date (Required, Optional, Not Required, Blank
Event Date SDV Date Shows the date when the Event Date underwent SDV
Total Forms SDV Complete Shows the total number of forms that completed SDV
Total Forms SDV Required Total number of forms completed for this event, where at least one field is SDV required
% Forms SDV Percentage of forms that underwent SDV at this event
SDV Completion Date The date on which all forms at this event completed SDV for this subject
DMR Plan The DMR plan assigned to subject at time of generation
Event Date DMR Shows whether or not the Event Date completed DMR (Yes/No value)
Event Date DMR Required Shows if DMR was required for the Event Date (Required, Optional, Not Required, Blank)
Event Date DMR Date Shows the date when the Event Date underwent DMR
Total Forms DMR Complete Shows the total number of forms that completed DMR
Total Forms DMR Required Total number of forms completed for this event, where at least one field is DMR required
% Forms DMR Percentage of forms that underwent DMR at this event
DMR Completion Date The date on which all forms at this event completed DMR for this subject
Event Signed Shows if event is signed (Yes/No value)
Event Signature Date The date when the event was signed
Event Frozen Shows if the event is frozen (Yes/No value)
Freeze Date The date when the event was frozen
Event Locked Shows if the event is locked (Yes/No value)
Lock Date The date when the event was locked
Last Run of Listing Datetime (UTC) when the listing was last run
Event ID Vof ID of the event

Form Progress Listing

The Form Progress Listing job generates a list of all Forms in the Study, with status details and operational data, as a CSV file.

Job Options

The following configuration options are available for the Form Progress Listing job:

  • Include Restricted Data: When this checkbox is selected, Vault includes data from restricted Forms if the job is initiated by a user with the Restricted Data Access permission.

Output

The Form Progress Listing job CSV includes the columns listed below. If your Study is using Data Model V1, the SDV Required, Items SDV Required Completed, Items SDV Required, SDV %, SDV Age, DMR Required, Items DMR Required Completed, Items DMR Required, DMR %, DMR Age, Lock Date, Freeze Date, and Sign Date columns will be blank in the CSV output.

Column Header Description
Study Study Name
Country Study Country Name
Site Site Number
Subject Subject Number
Subject Status Current Subject Status
Event Group Label Event Group Label of the Event Group where the Query is
Event Label Event Label of the Event where the Query is
Event Group Sequence Number Event Group Sequence Number
Event Date Event Date entered
Form Label Form Label
Form Sequence Number Form Sequence Number
Form Status Form Status (Planned, Blank, In Progress, Submitted, In Progress Post Submit)
Number of Submits Total number of Form submissions
Restricted Form Shows if the Form is Restricted or not (Yes/No value)
Complete Shows if the Form is complete/submitted, including ILB forms (Yes/No value)
Late Shows if the Form is late based on the Event Date and the number of overdue days allowed (Yes/No value)
Days Overdue Shows the number of days beyond the overdue date
SDV Plan SDV Review Plan assigned to the Subject
SDV Override Plan SDV Review Plan override for the Form (from an override rule)
SDV Shows whether or not SDV was completed for the Form
SDV Required Shows whether or not SDV is required for the Form
Items SDV Required Completed Number of items on the Form where SDV is required and completed
Items SDV Required Number of items on the Form where SDV is required
SDV % Percentage of SDV complete for the Form
SDV Age How long the Form has been submitted without SDV
SDV Date Date the Form was marked SDV
DMR Plan DMR Review Plan assigned to the Subject
DMR Override Plan DMR Review Plan override for the Form (from an override rule)
DMR Shows whether or not DMR was completed for the Form
DMR Required Shows whether or not DMR is required for the Form
DMR % Percentage of DMR complete for the Form
Items DMR Required Completed Number of items on the Form where DMR is required and completed
Items DMR Required Number of items on the Form where DMR is required
DMR Age How long the Form has been submitted without DMR
DMR Date Date the Form was marked DMR
Frozen Whether or not the Form is frozen (Yes/No value)
Freeze Date Date the Form was frozen
Locked Whether or not the Form is locked (Yes/No value)
Lock Date Date the Form was locked
Signed Whether or not the Form is signed
Sign Date Date the Form was signed
Last Signed Date Date the Form was last signed
Total Queries Total number of queries on the Form
Open Queries Total number of open queries on the Form
Answered Queries Total number of answered queries on the Form
Closed Queries Total number of closed queries on the Form
Last Run of Listing Datetime (UTC) when the listing was last run
Form Vault ID Vof ID of the Form

Query Detail Listing

The Query Detail Listing job generates a list of all Queries in the Study, with status details and operational data, as a CSV file. Users can filter this listing by Query Status, Query Team, Site, and Form. The output only includes Queries from restricted Forms if the user selected the Include Restricted Data checkbox and has the Restricted Data Access permission.

Job Options

The following configuration options are available for the Query Detail Listing job:

  • Include Restricted Data: When this checkbox is selected, Vault includes queries from restricted Forms if the job is initiated by a user with the Restricted Data Access permission.

Output

The Query Detail Listing job CSV includes the columns listed below. If your Study isn’t using Query Teams, the Query Team, Created by Query Team, Answered by Query Team, Closed by Query Team, Created by Role, Answered by Role, and Closed by Role columns will be blank in the CSV output.

Column Header Description
Study Study Name
Country Study Country Name
Site Site Number
Subject Subject Number
Subject Status Current Subject Status
Event Group Label Event Group Label of the Event Group where the query is
Event Label Event Label of the Event where the query is
Event Group Sequence Number Event Group Sequence Number
Event Date Event Date entered
Form Label Form Label of the Form where the query is
Form Sequence Number Form Sequence Number
Item Group Label Item Group Label of the Item Group where the query is
Item Group Sequence Number Item Group Sequence Number
Item OID (External ID) External ID (OID) of the item that the query is attached to
Item Label Label of the item that the query is attached to
Query ID The query name (VV-XXXXX) (not the internal vault ID)
Query Status Current Status of the query
Restricted Query Shows if the query is Restricted or not (Yes/No value)
Query Team Query Team assigned to the query
Days Unresolved Days the query has been unresolved
Manual Query Shows if the query was manually created (Yes/No value)
Query Rule If a query rule, the rule that originates the query
Original Query Text First message text of the query
Latest Query Comment Latest query message
Latest Query Answer Text Last answer of the query
Item Value Before Query Value of the item the query is attached to before query creation
Item Value Now Value of the item the query is attached to at the time of run
Item Value Changed Shows whether or not the value of the queried item changed (YES/No value)
Query Caused Data Change Shows whether or not the query caused a data change (Yes/No value). This field is determined by checking if the item value was modified between creation and closing of the query (by dates).
Created Date Datetime of the creation of the query
Created By User that created the query (or System)
Created By Role Role name of the user that created the query (or System)
Created by Query Team Query Team of the user that created the query
Answered Date Datetime of last answer of the query
Answered By User that last answered the query
Answered by Role Role name of the user that last answered the query
Answered by Query Team Query Team of the user that last answered the query
Closed Date Datetime of last closing of the query
Closed By User that last closed the query (or System)
Closed By Role Role name of the user that last closed the query (or System)
Closed by Query Team Query Team of the user that last closed the query
Last Run of Listing Datetime (UTC) when the listing was last run
Query Vault ID Vault Query Object

Reconstitute Code Requests

The Reconstitute Code Requests job updates existing Code Requests to reflect any configuration changes. This job can be useful if you’ve added Coding Configurations after a Study is live and Forms that require coding have been previously submitted.

Job Options

The following configuration options are available for the Reconstitute Code Requests job:

  • Select Forms: You can choose to run this job on all coding forms in a Study or on select forms.

Note: Frequency is disabled for this job. You can only run this job on an ad hoc basis.

Output

The job output for the Reconstitute Code Requests job includes four CSV files detailing record creation and updates for Code Requests during this job:

  • Code Requests Created
  • Code Requests Updated
  • Code Requests Failed to Create
  • Code Requests Failed to Update

Study Data Extract

The Study Data Extract job allows Lead Data Managers to extract and download study execution data.

Job Options

The following configuration options are available for the Study Data Extract job:

  • Include Restricted Data: When this checkbox is selected, Vault includes data from restricted Forms if the job is initiated by a user with the Restricted Data Access permission.

Output

When the Study Data Extract job is completed, you can download a SAS or CSV file for each selected Study. System Datasets include Sites (SYS_SITE), Subjects (SYS_SUB), Events (SYS_EVT), Forms (SYS_FORM), Queries (SYS_Q), Query Status (SYS_QT), Intentionally Left Blank fields (SYS_ILB), and Links (SYS_LINKS).

For more information about the Study Data Extract job, see Study Data Extracts.

Subject Progress Listing

The Subject Progress Listing job generates a list of all Subjects in the Study, with status details and operational data, as a CSV file.

Job Options

The following configuration options are available for the Subject Progress Listing job:

  • Include Restricted Data: When this checkbox is selected, Vault includes data from restricted Forms if the job is initiated by a user with the Restricted Data Access permission.

Output

The Subject Progress Listing job CSV includes the following columns:

Column Header Description
Study Study Name
Country Study Country Name
Site Site Number
Subject Subject Number
Subject Status Current Subject status
Restricted Subject Shows if the Subject is Restricted (Yes/No value)
Most Recent Visit Last visit/event label of scheduled visits
Date of Most Recent Visit Last visit/event date of scheduled visits
Next Event Next visit/event label of scheduled visits
Entry Complete Shows if all forms expected for a Subject have been submitted (Yes/No value)
SDV Plan SDV Plan assigned to the Subject
SDV Complete Shows if all forms and all event dates that require SDV have been marked SDV for the Subject
DMR Plan DMR plan assigned to the Subject
DMR Complete Shows if all forms and all event dates that require DMR have been marked DMR for the Subject
Frozen Shows if all forms and all event dates have been frozen for the Subject
Locked Shows if all forms and all event dates have been locked for the Subject
Signed Shows if all forms and all event dates have been signed for the Subject
All Queries Closed Shows if all queries for the Subject have been closed
Clean Shows if a Subject is "clean," meaning that all forms are submitted, signed, and locked and all queries are closed. SDV and DMR should also be completed (Yes/No value)
Forms Total number of forms for Subject
Forms Complete Number of forms submitted
Forms Incomplete Number of forms that are blank or in progress (e.g. forms that are not submitted yet)
Forms Need SDV Number of forms submitted that need to undergo SDV based on the review plan
Event Date Need SDV Number of event dates that require SDV that have been marked SDV for the Subject
Forms Need DMR Number of forms submitted that need to undergo DMR based on the review plan
Event Date Need DMR Shows if all event dates that require DMR have been marked DMR for the Subject
Forms Need Freeze Total number of submitted forms to be frozen
Event Date Need Freeze Total number of event dates to be frozen
Forms Need Lock Total number of submitted forms to be locked
Event Date Need Lock Total number of event dates to be locked
Forms Need Sign Total number of submitted forms to be signed
Event Date Need Sign Total number of event dates to be signed
Total MC Total Medical Coding Requests for the Subject
MedDRA MC Total MedDRA Medical Coding Requests
WHODrug MC Total WHODrug Medical Coding Requests
MedDRA MC Need Coding MedDRA Medical Coding Requests that are not yet coded
WHODrug MC Need Coding WHODrug Medical Coding Requests that are not yet coded
Total Queries Total number of queries
Open Queries Total number of open queries
Answered Queries Total number of answered queries
Closed Queries Total number of closed queries
Last Run of Listing Datetime (UTC) when the listing was last run
Subject Vault ID Vof ID of the Subject

Workbench Export

The Workbench Export job exports study data in Vault EDC and Vault Coder, and then sends the export package to Vault CDB. Vault CDB imports the data and creates a Core Listing for each form.

Job Options

There are no special configuration options for the Workbench Export job.

Output

Vault automatically sends the output file to Vault CDB. You can download and view the output from EDC Tools > Jobs or from Workbench > Import.