Running & Scheduling Study Jobs

From Review > My Studies > Job Schedule, you can manage export jobs occurring in your Study from a single location. A job represents a bulk evaluation or action upon collected study data. For example, the Data Export job exports selected study data in CSV or SAS format.

Viewing Jobs

From Review > My Studies > Job Schedule, you can view a history of in-progress and completed jobs. You can filter this list by Type and Frequency using the filter drop-down menus.

From this area, you can create new jobs, run scheduled jobs on an ad hoc basis, and delete existing jobs.

Job Types

From Review > My Studies > Job Schedule, you can initiate Detail PDFs and Data Export type jobs to export your Study data from Vault.

Summary

The table below summarizes the job types available in Review > My Studies > Job Schedule:

Job Type	Description
Core Listing	Exports Study data in a simplified CSV file. You can choose which Forms to include and which Sites to export data from.
Data Export	Exports study execution data as a series of either CSV or SAS files, in a format determined in your study’s design, to either download or send to a configured FTP location. The Data Export job may not be available in your vault. Contact Veeva Services for details.
Detail PDFs	Exports subject Casebooks as PDFs, including any entered data within those Casebooks. The PDF files exported from the Detail PDFs job in EDC Tools are optimized for Fast Web View.
Event Progress Listing	Generates a list of all Events in a Study with status details and operational information.
Form Progress Listing	Generates a list of all Forms in a Study with status details and operational information.
Query Detail Listing	Generates a list of all Queries in a Study with status details and operational information.
Subject Progress Listing	Generates a list of all Subjects in a Study with status details and operational information.
Form Progress Versioned Extract	Generates a list of all Forms in a Study with status details and operational information according to the selected version.
Event Progress Versioned Extract	Generates a list of all Events in a Study with status details and operational information according to the selected version.
Subject Progress Versioned Extract	Generates a list of all Subjects in a Study with status details and operational information according to the selected version.
Query Detail Versioned Extract	Generates a list of all Queries in a Study with status details and operational information according to the selected version.
Additive Review Listing	Exports a ZIP file containing a CSV file of a report for items and event dates that have been additively reviewed in a Study. Initiated from the Review tab. To run the Additive Review Listing job, Additive Review must be enabled for your study in Studio > Settings.
Study Summary Metrics Report	Generates a report with percentages of weekly or monthly monitoring of SDV and/or DMR activities. To generate this report, a user must have SDV/DMR permissions. Initiated from the Review tab.

Additive Review Listing

The Additive Review Listing job generates a CSV file containing items and event dates that have been additively reviewed in a Study. Additive Review must be enabled for your study in Studio > Settings to run the Additive Review Listing job.

Job Options

The following configuration options are available for the Additive Review Listing job:

• Review Task: You can choose to filter your listing by Review Task.

• Date Range: You can choose to apply a date range to your Additive Review Listing.

• Study Countries and/or Sites: You can choose to filter your listing by Country, Site, or both.

Output

When the Additive Review Listing job finishes, you can download a ZIP file containing a CSV file of the Additive Review Listing, which includes the columns below.

• Study
• Country
• Site
• Subject
• Subject Status
• Event Group Label
• Event Label
• Event Group Sequence Number
• Event Date
• Form Label
• Form Sequence Number
• Item Group Label
• Item Group Sequence Number
• Item Label
• Review Plan Type
• Last Reviewed By
• Last Reviewed Date
• Additive Reason
• Last Run of Listing

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 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 or report. 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 events from restricted Forms if the job is initiated by a user with the Restricted Data Access permission. An event becomes Restricted when the data that triggers a dynamic event contains a Restricted form and is updated by a user without Restricted permission and the Restricted form is included in the submitted event. A user with Restricted permission must perform an action to clear the newly unneeded form.

Output

The Event Progress Listing job CSV export and report include 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 and report 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
Visit Method	Visit Method selected
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 SDV Required	Shows if SDV was required for the Event (Required, Optional, Not Required, Blank)
Event SDV Complete	Shows whether the Event completed SDV (Yes/No value)
% Event SDV Complete	Shows the percentage of SDV completion for the Event
Event First SDV Completion Date	Shows the date that SDV for all forms in the event, and for Event Date and Visit Method if required, was first completed. This value will be cleared if the form or event is reset.
Forms SDV Completion Date	Shows the date when the forms in the Event underwent SDV
Visit Method SDV Required	Shows if SDV was required for the Visit Method (Required, Optional, Not Required, Blank)
Visit Method SDV Complete	Shows whether the Visit Method completed SDV (Yes/No value)
Visit Method SDV Complete Date	Shows the date when the Visit Method underwent SDV
Total Forms SDV Required	Total number of forms completed for this event, where at least one field is SDV required
Submitted Forms SDV Required	Number of submitted forms where SDV is required at the event
Total Forms SDV Complete	Shows the total number of forms that completed SDV
% Forms SDV	Percentage of forms that underwent SDV at this event
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 DMR Required	Shows if DMR was required for the Event (Required, Optional, Not Required, Blank)
Event DMR Complete	Shows whether the Event completed DMR (Yes/No value)
% Event DMR Complete	Shows the percentage of DMR completion for the Event
Event First DMR Completion Date	Shows the date that DMR for all forms in the event, and for Event Date and Visit Method if required, was first completed. This value will be cleared if the form or event is reset.
Forms DMR Completion Date	Shows the date when the forms in the Event underwent DMR
Visit Method DMR Required	Shows if DMR was required for the Visit Method (Required, Optional, Not Required, Blank)
Visit Method DMR Complete	Shows whether the Visit Method completed DMR (Yes/No value)
Visit Method DMR Complete Date	Shows the date when the Visit Method underwent DMR
Event Date DMR Date	Shows the date when the Event Date underwent DMR
Total Forms DMR Required	Total number of forms completed for this event, where at least one field is DMR required
Submitted Forms DMR Required	Number of submitted forms where DMR is required at the event
Total Forms DMR Complete	Shows the total number of forms that completed DMR
% Forms DMR	Percentage of forms that underwent DMR at this event
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 Date Signature Date	The date when the event was signed
Visit Method Frozen	Shows if the Visit Method was frozen (Yes/No value)
Visit Method Frozen Date	The date that the Visit Method was frozen
Visit Method Locked	Shows if the Visit Method was locked (Yes/No value)
Visit Method Locked Date	The date that the Visit Method was locked
Visit Method Signed	Shows if the Visit Method was signed (Yes/No value)
Visit Method Signature Date	The date that the Visit Method 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
Event ID	Vof ID of the event
Last Run of Listing	Datetime when the listing was last run

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, Items with Value Change, Items SDV Required Completed, Items SDV Required, Items DMR Required Completed, and Items DMR Required.

Output

The Form Progress Listing job CSV export and report include 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 %, and DMR Age columns will be blank in the job export and report 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 Form 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)
First Submission Date	Datetime when the Form was first submitted
Latest Submission Date	Datetime when the Form was last submitted
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
Marked for Removal	Shows whether the Form is no longer needed
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 Required	Shows whether SDV is required for the Form
Requires Re-SDV	Shows whether SDV needs to be completed again after being cleared due to updates by the site
SDV Complete	Shows whether SDV was completed for the Form
Items SDV Required	Number of items on the Form where SDV is required
Items SDV Required Completed	Number of items on the Form where SDV is required and completed
SDV %	Percentage of required 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 Required	Shows whether DMR is required for the Form
Requires Re-DMR	Shows whether DMR needs to be completed again after being cleared due to updates by the site
DMR Complete	Shows whether DMR was completed for the Form
Items DMR Required	Number of items on the Form where DMR is required
Items DMR Required Completed	Number of items on the Form where DMR is required and completed
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
Form Vault ID	Vof ID of the Form
Last Run of Listing	Datetime when the listing was last run

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. Note that if you have the Show Queries in the User Language setting configured, queries will display in the user’s language, not the vault language.

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 export and report include 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 and report 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
Visit Method	Visit method selected
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
Source Type	Source type of the query
Source System Name	Value optionally set by an API query addition, describing the name of the query source system
Source User	Value optionally set by an API query addition, describing the user who opened the query
Source ID	Unique identifier from the source of 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
Original Query Text in User's Language	Original text of the query in the User’s language
Original Query Text in English	Original text of the query in English
Latest Query Comment	Latest query message
Latest Query Answer Text	Last answer of the query
Number of Query Messages	The number of query messages on a 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 data changed after query creation (Yes/No value). This field is determined by checking if the item value was modified between creation and closing of the query (by dates).
Query Created Date	Datetime of the creation of the query
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
Query Vault ID	Vault Query Object
Last Run of Listing	Datetime when the listing was last run

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 export and report include 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	Event Label of the last visit/event
Date of Most Recent Visit	Event Date of the last visit/event
Method of Most Recent Visit	Visit Method of the last visit/event
Next Event	Event Label of the next scheduled visit/event
Entry Complete	Shows if all forms expected for a Subject have been submitted (Yes/No value)
SDV Plan	SDV Plan assigned to the Subject
Subject SDV Required	Shows whether SDV is required for the Subject
Subject SDV Complete	Shows if all forms and all event dates that require SDV have been marked SDV for the Subject
Subject SDV Completion Date	The date that SDV was completed 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
Subject DMR Required	Shows whether DMR is required for the Subject
Subject DMR Complete	Shows if all forms and all event dates that require DMR have been marked DMR for the Subject
Subject DMR Completion Date	The date that DMR was completed for the Subject
Forms DMR Completion Date	The date that DMR was completed on all forms for the Subject
Frozen	Shows if all forms, event dates, and visit methods have been frozen for the Subject
Locked	Shows if all forms, event dates, and visit methods have been locked for the Subject
Signed	Shows if all forms, event dates, and visit methods 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, event dates, and visit methods 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 SDV Required	Number of forms that are SDV required for the subject
Submitted Forms SDV Required	Number of submitted forms that are SDV required for the subject
Forms SDV Complete	Number of forms that were marked as SDV reviewed for the subject
% Forms SDV Complete	Percentage of forms that were marked as SDV reviewed for the subject compared to the number of forms marked SDV required
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
Visit Methods Not SDV	Number of visit methods that require SDV that have not been marked SDV for the Subject
Forms DMR Required	Number of forms that are DMR required for the subject
Forms DMR Complete	Number of forms that were marked as DMR reviewed for the Subject
Submitted Forms DMR Required	Number of submitted forms that are DMR required for the subject
% Forms DMR Complete	Percentage of forms that were marked as DMR reviewed for the subject compared to the number of forms marked DMR required
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
Visit Methods Not DMR	Number of visit methods 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
Visit Methods Not Frozen	Total number of visit methods 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
Visit Methods Not Locked	Total number of visit methods 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
Visit Methods 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
Subject Vault ID	Vof ID of the Subject
Last Run of Listing	Datetime when the listing was last run

Datetime fields for Study Listing jobs display in the user’s timezone.

Study Summary Metrics Report

The Study Summary Metrics Report generates a report of SDV and/or DMR activities as a ZIP file containing multiple CSV files.

Job Options

The following configuration options are available for the Study Summary Metrics Report job:

• Review Task: Vault includes data about SDV, DMR, or both, depending on the User’s selections and permissions.

• Aggregation Options: You can choose for the report to summarize at the Study Country and/or Site level.

• Study Countries and/or Sites: You can choose to filter your results by Study Country, Site, or both.

• 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 Study Summary Metrics Report includes individual CSV files for each aggregate level, delivered in a ZIP file.

Running Jobs

CRAs and data managers can create new, ad hoc jobs for Detail PDF generation and, if enabled, data export.

To run a job:

1. Navigate to Review > My Studies > Job Schedule.
2. Click + New.

3. In the New dialog, select a Job Type. See details about each job type above.

4. Depending on the selected Job Type, different options display. Make the required selections.
5. Click Save.
6. Vault begins the job. When finished, Vault sends you an email notification with a link to download the job log and any relevant output files.

Scheduling Jobs

In addition to running ad hoc jobs, lead data managers can schedule regularly recurring jobs for Detail PDF generation and, if enabled, data export.

To schedule a job:

1. Navigate to Review > My Studies > Job Schedule.

2. Click + New.

3. In the New dialog, select a Job Type.
4. Depending on the selected Job Type, different options display. Make the required selections.
5. Select a Frequency.
6. Depending on your Frequency selection, select a time for Run at and set the days to run the job.
7. Enter a Name for your job.
8. Click Save.
9. Vault begins the job. When finished, Vault sends you an email notification with a link to download the job log and any relevant output files.

Ad Hoc Job Runs

You can choose to run an ad hoc instance of your existing scheduled jobs.

To run a job:

1. Navigate to the Job Schedule subtab in Review > My Studies.
2. Scroll to the Job you want to run.
3. From the Actions menu, select Run Now.
4. Vault begins the job. When finished, Vault sends you an email notification with a link to download the job log and any relevant output files.

Editing a Scheduled Job

When needed, you can edit a scheduled job. For example, you may want to have a job run weekly on Friday instead of Thursday.

To edit a job:

1. Navigate to the Job Schedule subtab in Review > My Studies.
2. Scroll to the Job you want to edit.
3. From the Actions menu, select Edit Job.
4. Make changes to the job definition in the Edit Job dialog.
5. Click Save. Vault EDC now runs your job using the updated schedule.

Deleting a Job

To delete a job:

1. Navigate to the Job Schedule subtab in Review > My Studies.
2. Scroll to the Job you want to delete.
3. From the Actions menu, select Delete.
4. In the Delete Record confirmation dialog, click Continue.
5. Vault deletes the job. The job will not run again. Any job logs and related output files remain available in the Job History subtab until they expire.

Canceling a Job

You can cancel an In Progress instance of the Extracts & Listings job.

To cancel a job:

1. Navigate to the Job Schedule subtab in Review > My Studies.
2. Locate the job that you want to cancel.
3. Hover over the Job to show the Actions menu.
4. From the Actions menu, select Cancel.
5. In the confirmation dialog, click Cancel Job.

Vault stops the job and moves it into the Canceled status.

Refreshing the Job Status

You can refresh the job status in the Listings & Exports subtab without refreshing the page to see the most up-to-date job status and any available logs or output files. You can also view job progress in the Job History or Job Schedule tab.

Click Refresh () to refresh the log.

Job Statuses

Vault displays the status of your job in the job history, along with other details about the job. You can click the Information () icon for additional details about a job.

Status	Meaning
Queued	Another job of the same type is currently running. Vault will run this job when the previous job is completed.
In Progress	Vault is currently performing the job.
Failed	The job instance encountered one or more errors.
Completed	The job instance completed without errors.
Canceled	The job instance was canceled.

Job Logs & Output Files

Vault provides a CSV job log file for each job. This log includes details about which objects were affected by the job and whether or not the job was successful on each object. When applicable, Vault also provides a link to the output files from a job. For example, a link to download the ODM XML file for an ODM Export job.

To access these files, click the icon () in either the Log or File column.

You can view tables with potential audit descriptions for each study object below:

Casebook

Object	Potential Audit Description
Casebook	"Casebook Definition" changed from "[text]" to "[text]"
Casebook	Casebook frozen
Casebook	Casebook unfrozen
Casebook	Casebook locked
Casebook	Casebook unlocked
Casebook	Casebook: [Screening ID #] created

Event

Object	Potential Audit Description
Event	"[Date]" was removed from the "Event Date" field
Event	"[Date]" was removed from the "Overdue Date" field
Event	"Change Reason" set to "[Reason]"
Event	"Change Reason" changed from "[Reason]" to "[Reason]"
Event	"Did Not Occur" set to "True"
Event	"Did Not Occur" set to "False"
Event	"Event Date" set to "[Date]"
Event	"Event Date" changed from "[Date]" to "[Date]"
Event	"Overdue Date" set to "[Date]"
Event	"Overdue Date" changed from "[Date]" to "[Date]"
Event	Event: [Event Name] created
Event	Event Date DMR set to "False"
Event	Event Date DMR set to "True"
Event	Event Date SDV set to "False"
Event	Event Date SDV set to "True"
Event	Event Date signed. Signature meaning: [Signature Meaning]
Event	Event Date unsigned
Event	Event unfrozen
Event	Event frozen
Event	Event unlocked
Event	Event locked
Event	Event Date frozen
Event	Event Date unfrozen
Event	Event Date locked
Event	Event Date unlocked
Event	Query opened: [Query message]
Event	Query answered: [Query message]
Event	Query closed: [Query message]
Event	Query reopened: [Query message]
Event	"Overdue Date" set to "[Date]"
Event	"Overdue Date" changed from "[Date]" to "[Date]"
Event	"User Review Modified By" set to [User]
Event	Event reset. Reason for reset: "[Reason]"
Event	"Visit Method" set to "[Visit Method]"
Event	"[Visit Method]" was removed from the "Visit Method" field
Event	"Visit Method" was changed from "[Visit Method]" to "[Visit Method]"
Event	Visit Method signed
Event	Visit Method signature broken
Event	Visit Method unsigned
Event	Visit Method frozen
Event	Visit Method unfrozen
Event	Visit Method locked
Event	Visit Method unlocked

Event Group

Object	Potential Audit Description
Event Group	Event Group: [Event group name] created

Form

Object	Potential Audit Description
Form	"Change Reason" set to "[Reason]"
Form	"Change Reason" changed from "[Reason]" to "[Reason]"
Form	"Form Status" changed from "[Status]" to "[Status]"
Form	"Intentionally Left Blank Reason" set to "[Reason]"
Form	"[Reason]" was removed from the "Intentionally Left Blank" field
Form	"Intentionally Left Blank" set to "True"
Form	"Intentionally Left Blank" changed from "False" to "True"
Form	"Intentionally Left Blank" changed from "True" to "False"
Form	"Marked for Removal" set to "True"
Form	"Marked for Removal" changed from "True" to "False"
Form	"Number of Submits" changed from "[#]" to "[#]"
Form	"Submission Date" set to "[Date]"
Form	"Submission Date" changed from "[Date]" to "[Date]"
Form	Form: [Form Name] created
Form	Form signed. Signature Meaning: "[Signature meaning]"
Form	Form unsigned
Form	Form frozen
Form	Form unfrozen
Form	Form locked
Form	Form unlocked

Item

Object	Potential Audit Description
Item	"DMR Mode" set to "[Review Mode]"
Item	"SDV Mode" set to "[Review Mode]"
Item	"User Review Modified By" set to [User]
Item	Item: [Item Name] created
Item	Item DMR set to "True"
Item	Item DMR set to "False"
Item	Item SDV set to "True"
Item	Item SDV set to "False"
Item	Item frozen
Item	Item unfrozen
Item	Item set as Intentionally Left Blank with reason "[Reason]". Reason for change: "[Reason]"
Item	Item unset as Intentionally Left Blank. Reason for change: "[Reason]"
Item	"Intentionally Left Blank Reason" changed from "[Reason]" to "[Reason]"
Item	Query opened: [Query message]
Item	Query answered: [Query message]
Item	Query closed: [Query message]
Item	Query reopened: [Query message]
Item	Translated value set to "[Value]". Reason for change: "[Reason]"
Item	Translated value changed from "[Value]" to "[Value]". Reason for change: "[Reason]"
Item	Value entered "[Value]". Reason for change: "[Reason]"
Item	Value changed from "[Value] to "[Value]". Reason for change: "[Reason]"
Item	Value is "[Value]". Change Reason changed from "[Reason]" to "[Reason]"
Item	"User Review Modified By" set to [User]

Item Group

Object	Potential Audit Description
Item Group	"Change Reason" set to "[Reason]"
Item Group	"Change Reason" changed from "[Reason]" to "[Reason]"
Item Group	"Intentionally Left Blank Reason" set to "[Reason]"
Item Group	"Intentionally Left Blank" changed from "False" to "True"
Item Group	"Intentionally Left Blank" changed from "True" to "False"
Item Group	"Intentionally Left Blank" set to "True"
Item Group	Item Group: [Item Group Name] created

Link Form

Object	Potential Audit Description
Link Form	[Form Name](Seq #) link to [Form Name](Seq #) created

Protocol Deviation

Object	Potential Audit Description
Protocol Deviation	"Category" changed from "[PD Category]" to "[PD Category]"
Protocol Deviation	"Date of Deviation" changed from "[Date]" to "[Date]"
Protocol Deviation	"Description" set to "[description]"
Protocol Deviation	"Description" changed from "[description]" to "[description]"
Protocol Deviation	"Inactivated by System" set to "True"
Protocol Deviation	"Last Inactivated Date" set to "[Date]"
Protocol Deviation	"Protocol Deviation Status" changed from "[Status]" to "[Status]"
Protocol Deviation	"Resolution" set to "[Resolution]"
Protocol Deviation	"Resolution" changed from "[Resolution]" to "[Resolution]"
Protocol Deviation	"Severity" changed from "[Severity]" to "[Severity]"
Protocol Deviation	"Subcategory" changed from "[Subcategory]" to "[Subcategory]"
Protocol Deviation	"Summary" changed from "[Summary]" to "[Summary]"
Protocol Deviation	"User Modified By" changed from "[User]" to "[User]"
Protocol Deviation	"User Modified By" set to "[User]"
Protocol Deviation	"User Modified Date" changed from "[Datetime]" to "[Datetime]"
Protocol Deviation	"User Modified Date" set to "[Datetime]"
Protocol Deviation	Protocol Deviation: [PD Name] created

Subject

Object	Potential Audit Description
Subject	"Enrolled Date" set to "[Date]"
Subject	"Enrolled Date" changed from "[Date]" to "[Date]"
Subject	"Name" changed from "[Subject ID]" to "[Subject ID]"
Subject	"Screened Date" set to "[Date]"
Subject	"End of Treatment Date" set to "[Date]"
Subject	"Subject Status" changed from "[Status]" to "[Status]"
Subject	"Withdrawn Date" set to "[Date]"
Subject	"Withdrawn Date" changed from "[Date]" to "[Date]"
Subject	Subject: [Subject name] created
Subject	"Randomized Date" set to "[Date]"