Summary
This article covers the functionalities of the studies manager.
Table of Contents
- Access Studies Manager
- Available Columns and Filter Types
- Actions
- Choose an Action – Press Go
- Lock/Unlock Study
The Studies Manager will deliver a high level overview of the studies currently enrolled within CTMS. On this screen, users will be able to view information such as enrollment status, therapeutic area, and actual vs expected enrollment levels.
Access Studies Manager
From within the CTMS platform, click the expandable menu to the left of the screen and select Studies.
Available Columns and Filter Types
The Studies Manager columns can be dragged and dropped between the Manager and Filters Menu. The values of the Protocol column serve as a link to the records they represent. For more information see the article on CTMS Managers.
The following table defines each column, the actions made available through the column value and the filters and sorts available.
| Name | Value | Action | Sortable | Filters |
|---|---|---|---|---|
| Active Status | Indicates if the study record is active or deleted. | (none) | Yes | Choice |
| Protocol | Displays the protocol number for the study. | Links to the associated Study form. | Yes | Text |
| Product | Displays the product being tested for the study. | (none) | Yes | Choice |
| Country | Displays the countries the study will be run in. | (none) | No | Choice |
| Sponsor | Displays the sponsor of the study. | (none) | Yes | Choice |
| Study Status | Displays the status of the study. | (none) | Yes | Choice |
| Indication | Displays the indication of the study. | (none) | No | Choice |
| Phase | Displays the phase of the study. | (none) | Yes | Choice |
| Therapeutic Area | Displays the therapeutic area of the study. | (none) | Yes | Choice |
| Actual/Expected Subjects | Displays the expected subjects based on the project plan and the actual number of subjects entered in the study. | (none) | No | None |
| Unique Study ID | Displays the system generated study id of the study. | (none) | Yes | Text |
| Locked Status* | Displays whether the study is locked or unlocked. | (none) | Yes | Choice |
Note: Locked studies can be used as a category for CTMS Billing.
Actions
The Actions Menu can be expanded by clicking and contains the following options.
Add Study
By clicking the Add Study action, you will be directed to a new Study form that can be saved to add a new record to the manager.
Exports
By selecting the options Excel or CSV, the system will provide an export of the information currently displayed in the Manager Table in the chosen format. The content of this export will be based on the filters applied to the table at the time of export.
Choose an Action – Press Go
The Choose an Action – Press Go dropdown can be expanded by clicking and contains the following options.
Deletion
A Study record can be deleted and restored through the Study Manager.
If a study has the following linked records added to the study, the study cannot be deleted.
- Vendors
- Sites
- Personnel
- Regulatory Bodies
- Regulatory Requirement Sets
The connection must be removed before the record can be deleted.
To Delete
To delete a study, the Active Studies Status must be set to Active Only.
- Select the checkbox by the study record.
- Select Delete Checked in the Choose an Action Press-Go dropdown.
- Select Delete button on the Confirmation Page.
Note: Attempting to delete a locked study will result in a warning that the study is locked and must be unlocked to be deleted.To Restore
To restore a deleted study, the Active Studies Status must be set to Deleted Only.
- Select the checkbox by the study record.
- Select Restore Checked in the Choose An Action Press-Go dropdown.
- Select Restore button on the Confirmation Page.
Note: When you restore a study that has links to deleted Product or Vendor records the Vendor and Product records are also restored when the study is restored.
Remove Linked Records
In the Study Manager there is an ability to remove all linked sites and vendors from the study. Only CTMS Admin roles will see this Action.
- Select the checkbox by the study record.
- Select Remove Linked Records in the Choose an Action Press-Go dropdown.
- The Linked Records to Study Protocol screen will appear with each vendor and site added to a study.
- Select the checkbox by each vendor or site to remove the link.
- Select Remove button.
- Select Confirm button on the confirmation screen to remove the vendor or site from the study.
Lock/Unlock Study
Note: Locked studies can be used as a category for CTMS Billing.
When a new study is created, the Locked Status defaults to “Open”. An open study accepts changes to data. A locked study is in a read only mode, but retains some functionality such as:
- Navigation options to Trial Manager and EDC
- Some Regulatory exports
- Document downloads from Regulatory Edit Submission screen
- Regulatory template and configuration downloads
- Version History on the Visit Schedule
- Reporting
The ability to lock and/or unlock a study is limited to users with the read/write access to the Study Manager. Locked Status changes are tracked in the Form Audits Manager.
- Select the checkbox(es) by the study record(s).
- Select Lock Study or Unlock Study option in the Choose an Action Press-Go dropdown.
- Confirm the action by clicking the appropriate button.
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