Standard CDMS Report Templates
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.
Availability: Reporting functionality related to documents is not available in Vault CDMS.
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: Casebook Signature Summary | Summary of Casebooks with signatures | Casebook Operational Summary with Site |
| Standard Template: Frozen Casebook Summary | Summary of frozen Casebooks | Casebook Operational Summary with Site |
| Standard Template: Locked Casebook Summary | Summary of locked Casebooks | Casebook Operational Summary with Site |
| Standard Template: Event Status | Summary of Events with signatures | Template: Event with Event Definitions and Study and Site and Subject |
| Standard Template: Event Signature Summary | 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 (v2) | 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 (v2) | Summary of frozen Forms | Template: Study Site with Form |
| Standard Template: Frozen Event Summary (v2) | Summary of frozen Events | Template: Event with Event Definitions and Study and Site and Subject |
| Standard Template: Locked Form Summary (v2) | Summary of locked Forms | Template: Study Site with Form |
| Standard Template: Locked Event Summary (v2) | Summary of Locked Events | Template: Event with Event Definitions and Study and Site and Subject |
| 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 Subject) Forms (CRFs) by Study | Template: Form Definition |
| Study Closeout Status | Listing of Sites and their Site Closeout Status by Study | Template: Study Closeout |
| 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 (v2) | 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 |
| Safety | ||
| Safety Cases | Listing of Safety Cases | Template: Safety |
| Safety Messages | Listing of Safety Messages | Template: Safety |
| 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.
| 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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
EDC |
| Template: Safety | This report type can list information about Safety Cases and Safety Messages, with context from the Safety Case Form. | Safety Case |
|
EDC, Safety |
Related Permissions
Reporting functionality is available by default to users with the following standard study roles:
- CDMS Clinical Coder
- CDMS Clinical Coder Administrator
- CDMS Clinical Research Associate
- CDMS Data Manager
- CDMS Lead Data Manager
- CDMS Study Designer
- CDMS User Administrator
If your organization uses custom Study Roles, you must have the Reports Dashboards Tab and Schedule Reports permissions to use all reporting functionality.