Vault CDMS leverages the Vault Platform to provide reporting capabilities for operational metrics. Veeva provides standard report templates that you can create reports from or copy and configure your own.

If you open a linked object record from a report, Vault EDC opens that object record in the related area of Vault CDMS, not in an object record Details page.

Veeva Standard Report Template Policy

Standard report templates represent how Veeva Vault CDMS would display operational metrics. These standard templates provide a reference for custom reports customers may require in the conduct of their study. Standard report templates are locked to all users. If a customer would like to use a template in the execution of their study, they must create a copy of the template. Versions of the standard template reports are visible in the description.

Standard report templates are not supported as part of the contract with Veeva Vault CDMS and are subject to change. Therefore, customers should not base their standard operating procedures on the provided templates.

Available Templates

The following standard report templates are available in Vault CDMS:

Template Description Report Type
Site Performance
Standard Template: Event Status Total Events by Status and Site Template: Event with Event Definitions and Study and Site and Subject
Standard Template: Form Cycle Time Summary Summary of Form cycle time metrics Template: Form Cycle Time Summary
Standard Template: Form SDV Summary Summary of source data verified Forms Template: Study Site with Form
Standard Template: Form SDV Monitoring Activity per Week Summary of Form SDV monitoring activity per week by Site Template: Form with Event and Study Site and Subject
Standard Template: Form Signature Summary Summary of signed Forms Template: Study Site with Form
Standard Template: Form Status Summary report of Site-level Form status Template: Form with Event and Study Site and Subject
Standard Template: Frozen Form Summary Summary of frozen Forms Template: Study Site with Form
Standard Template: Locked Form Summary Summary of locked Forms Template: Study Site with Form
Standard Template: Query Aging by Site Summary of query counts by Site and Query Age (<1 Day, 1-3 Days, 3-5 Days, 5-7 Days, >7 Days) Template: Query Cycle Time Summary
Standard Template: Query Cycle Time Summary Summary of query cycle time metrics to assess Sites on responsiveness and data conflict resolution Template: Query Cycle TIme Summary
Standard Template: Query Volume per Form Number of query executions on a specific Form design (Form Definition) across a Study Template: Form with Form Definition and Query Binding
Standard Template: Query Volume per Week by Site Number of queries generated across Sites in the Study each week Template: Study Site with Query Binding
Standard Template: Site Queries Summary report of query count based on status at each Site in the Study Template: Study Site with Query Binding
Standard Template: Cumulative Subject Creation per Week Cumulative Subject creation within the EDC system for each Site Template: Subject
Standard Template: Subject Study Progression Summary of a Subject’s progression through the Study Template: Event with Event Definitions and Study and Site and Subject
Standard Template: Subject Summary Number of Subjects in each Status Template: Subject with Study and Study Site
Standard Template: Unique CRF Listing Listing of unique (per SubjectForms (CRFs) by Study Template: Form Definition
Actionable
Standard Template: Detailed Missing Forms Report Listing of Forms missing per Site and Subject Template: Form with Event and Study Site and Subject
Standard Template: Form SDV Detail Detailed listing of Form SDV status Template: Form with Event and Study Site and Subject
Standard Template: Form DMR Summary Summary listing of Form DMR status by Study Site Template: Study Site with Form
Standard Template: Items Intentionally Left Blank Listing of Items in subject Casebooks that a data entry user marked as Intentionally Left Blank Template: Item with Item History
Standard Template: Query Details by Site and Subject Detailed listing of queries per Subject Template: Query with Subject and Query Binding and Query Message
Standard Template: Comprehensive Form Summary Detailed listing of submitted Forms and Form Review Status by Study Site and Subject Template: Form with Event and Site and Subject
Operational
Standard Template: Overdue Form Entry per Event Summary of Events with overdue data entry tasks, including estimated Form workload Template: Event with Event Operational Summary
Standard Template: Schedule Deviation Report Summary of Study Site and Subject adherence to the planned visit schedule per Study protocol Template: Event Operational Summary
Standard Template: Queries Leading to Data Changes Summary list of system-generated Queries that lead to data changes Query Operational Summary with Query
Study Design
Standard Template: Form Reason for Change Report Summary count of reasons for post-submit Form changes Template: Item with Item History
Standard Template: Query Volume by Rule Definition Number of query executions for each Rule Definition Template: Rule Definition with Study and Query Binding
Reviews (For Studies created after the 19R3 release)
Standard Template: Form SDV Monitoring Activity per Week (v2) Summary of Form SDV monitoring activity per week by site Form with Event, Study Site, Subject, Form Summary
Standard Template: Form DMR Monitoring Activity per Week (v2) Summary of Form DMR monitoring activity per week by site Form with Event, Study Site, Subject, Form Summary
Standard Template: Form SDV Summary (v2) Summary listing of Form SDV status Form with Study Site and Summary
Standard Template: Form DMR Summary (v2) Summary listing of Form DMR status Form with Study Site and Summary
Standard Template: Form SDV Detail (v2) Detailed listing of Form SDV status by Site Form with Event, Study Site, Subject, Form Summary
Standard Template: Form DMR Detail (v2) Detailed listing of Form DMR status by Site Form with Event, Study Site, Subject, Form Summary
Persona-Based Dashboards
* These reports exist to power persona-based dashboards.
Dashboard: Out of Range Event Total Number of out of range Events Template: Event with Event Operational Summary
Dashboard: Number of Enrolled Subjects Number of enrolled Subjects by Study Template: Subject with Study and Study Site
Dashboard: Open Queries Number of open queries Template: Query Cycle Time Summary
Dashboard: Answered Queries Number of answered queries Template: Query Cycle Time Summary
Dashboard: Form Status (Not Completed) Number of Forms not in the Completed status Template: Form with Event and Study Site and Subject
Dashboard: Query Volume by Form Number of Queries by Form Template: Form with Form Definition and Query Binding

Available Report Type Templates

The following standard Report Type templates are available within Vault CDMS. Learn more about report types.

Name Description Primary Reporting Object Related Objects Application
Template: MC Item Def, Request & DictRel This report type can list information about dictionary releases, coding configuration (Item Definitions), and Code Requests. Medical Coding Item Definition
  • Medical Coding Dictionary Release
  • Medical Coding Request
Coder
Template: Event Operational Summary This report type can track the number of expected forms, the number of days overdue the forms in the event are, the event date, and the number of days outside of the event window the event date is. Event Operational Summary N/A EDC
Template: Event with Event Definitions and Study and Site and Subject This report type can display information about Events with reference information about the event design, the Study, the Site, and the Subject associated with the Event. Event
  • Event Definition
  • Study
  • Site
  • Subject
EDC
Template: Event with Event Operational Summary This report type can display the Event Operational Summary as well as event details like the review status, creation date, and the Planned Date. Event Event Operational Summaries EDC
Template: Form Cycle Time Summary This report type can list the average time taken for each form to be completed/submitted Form Operational Summary N/A EDC
Template: Form Definition This report type can display form definitions. Form Definition N/A EDC
Template: Form with Event and Study Site and Subject This report type can display information about Forms with reference information about SDV Details and Status Form
  • Event
  • Site
  • Subject
EDC
Template: Query Cycle Time Summary This report type can list the average time taken for each query to be answered or resolved Query Operational Summary N/A EDC
Template: Query with Subject and Query Binding and Query Message This report type can list Subjects, Sites, and information regarding Queries and Query Binding and Messages. Query
  • Subject
  • Query Bindings
  • Query Messages
EDC
Template: Rule Definition with Study and Query Binding This report type can list Rule Definitions as well as information regarding Name, Query Binding, and Study Site Rule Definition
  • Query Bindings
  • Study
EDC
Template: Study Site with Form This report type can list information regarding the Study Site name and reference information about corresponding Forms. Study Site Forms EDC
Template: Study Site with Query Binding This report type can list information regarding Study Sites and the corresponding Queries. Study Site Query Bindings EDC
Template: Subject This report type can provide information regarding the subject. Subject N/A EDC
Template: Subject with Study and Study Site This report type can list information regarding Subject Status and Study Site. Subject
  • Site
  • Study
EDC

In vaults without CDMS Role by Study enabled, reports and dashboards are only available for users with the Vault Owner, EDC Data ManagerEDC Lead Data ManagerEDC CRA, EDC Lead CRA, EDC Monitor User, and EDC Investigator security profiles by default.

In vaults with CDMS Role by Study enabled, reports and dashboards are available by default to users with the Data Review, Data Manager, Lead Data Manager, Coder, Coder Admin, Design, User Administrator, and Vault Owner security profiles by default.

If your vault uses custom security profiles, your security profile must have the Read Dashboards and Reports permission and the Objects: Reports: View permission to view reports. Contact Veeva Services to assign users these permissions.

Additional permissions are required to create, delete, or share reports. See About Permission Sets and Reporting Overview for details about reporting permissions.