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.

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Job Options

The following configuration options are available for the __ job:

Output

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. You must have the View Code permission to view these columns.

• 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 (Deprecated)

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. The Event Progress Listing job is versionless.

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
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 Type	Event Type
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 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 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 Date Frozen	Shows if the Event Date was frozen (Yes/No value)
Event Date Frozen Date	The date that the Event Date was frozen
Event Date Locked	Shows if the Event Date was locked (Yes/No value)
Event Date Locked Date	The date that the Event Date was locked
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 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. The Form Progress Listing job is versionless.

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.

• Include Item Counts: When this checkbox is selected, Vault includes item counts for All Items, Items with Values, and Items with Value Change.

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)
Intentionally Left Blank	Shows if the Form was Intentionally Left Blank (Yes/No value)
Intentionally Left Blank Reason	The reason the Form was marked as Intentionally Left Blank
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
All Items	Calculates the total number of items on the form
Items with Values	Calculates the number of items on the form with a saved value
Items with Value Change	Calculates the number of items on the form with at least one data value change
SDV Plan	SDV Review Plan assigned to the Subject
SDV Override Plan	SDV Review Plan override for the Form (from an override rule)
SDV Complete	Shows whether SDV was completed for the Form
SDV Required	Shows whether 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 Complete	Shows whether DMR was completed for the Form
DMR Required	Shows whether DMR is required 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 %	Percentage of DMR complete for the Form
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 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. The Query Progress Listing job is versionless.

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
Form Status	Form Status
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 the value of the queried item changed (Yes/No value)
Query Caused Data Change	Shows whether 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 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.

• Include Randomization Treatment: When this checkbox is selected, Vault includes randomized treatment information in the SYS_RAND dataset if the job is initiated by a user with Randomization enabled.

• SDE Version: You can choose which version of the SDE to run. Columns may be added, removed, and/or changed between versions.

• External Connection: You can select an External Connection to receive the output file. Vault will send you a link to download the output when the job finishes if an External Connection isn’t selected.

• Include Study Design (only available for 22R3 version): When this checkbox is selected, Vault includes a Definitions folder containing study design information in your extract.

Output

When the Study Data Extract job is completed, you can download a SAS or CSV file for each selected Study.

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. The Subject Progress Listing job is versionless.

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
Forms SDV Completion Date	The date that SDV was completed on all forms 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
Forms DMR Completion Date	The date that DMR was completed on all forms 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 Not SDV	Number of forms submitted that require SDV based on the review plan but have not been marked for SDV
Event Dates Not SDV	Number of event dates that require SDV that have not been marked SDV for the Subject
Forms Not DMR	Number of forms submitted that require DMR based on the review plan but have not been marked for DMR
Event Dates Not DMR	Number of event dates that require DMR that have not been marked DMR for the Subject
Forms Not Frozen	Total number of submitted forms that are not frozen
Event Dates Not Frozen	Total number of event dates that are not frozen
Forms Not Locked	Total number of submitted forms that are not locked
Event Dates Not Locked	Total number of event dates that are not locked
Forms Not Signed	Total number of submitted forms that are not signed
Event Dates Not Signed	Total number of event dates that are not 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 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 Veeva 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.