Summary
This article covers the tasks that can be performed through the manage submissions screen.
Table of Contents
- Access Manage Submissions Screen
- Available Columns and Filter Types
- Choose an Action Press Go Menu
- Actions
The Manage Submissions screen is a central location where all submissions in a study can be tracked. Each regulatory submission or amendment is associated with one regulatory body found in the Study Regulatory Bodies Manager. The manager table found on this screen presents a high level overview of the submissions in the study with information concerning who created the submission, what its submission status is, and whether or not a decision has been received from the associated regulatory authority.
Access Manage Submissions Screen
From within a study in CTMS, expand the Study navigation tree and locate the Regulatory sub menu. Expand the Regulatory option and select Manage Submissions.
Available Columns and Filter Types
The Submissions Manager has many columns that can be dragged and dropped between the manager and filters menu. The values of the Regulatory Bodies and Name columns serve as links 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 |
| Name | Displays the name of the submission. | Links to the associated Submission form. | Yes | Text |
| Regulatory Body | Displays the name of the regulatory body. | Links to the associated Regulatory Body form. | Yes | Text |
| Countries | Displays the countries associated with the regulatory submission. | (none) | Yes | Choice |
| Type | Displays whether the entry in the table is a submission or an amendment. | (none) | No | Choice |
| Created | Displays the date the submission or amendment was created, and the user responsible for creating it. | (none) | Yes | Date |
| Status | Displays the submission status for the entry. Can be Incomplete, Ready For Submission, or Submitted. Hovering over the Submitted status icon will display the name of the user who submitted and the date of submission. | (none) | No | Choice |
| Decision | Displays the decision status for the entry in the table. Can be Approved, Rejected, or Undecided. | (none) | No | Choice |
| Active Status | Indicates if the submission or amendment is active or deleted. | (none) | Yes | Choice |
Audits | Provides access to an audit table for regulatory submission. | When the icon is clicked, the system displays the audit table | No | (none) |
Choose an Action Press Go Menu
The CAPG Menu can be used to provide a range of statuses, aside from the usual delete and restore, to regulatory submissions.
Submit
Applying this action to one or more entries in the table will transition their submission status to the green Submitted status. Upon selecting this action and clicking the Go! button, the user will be prompted to enter a date of submission.
The value entered will populate to the Date of Submission field on the Submission form.
Remove Submission Status
This will clear the green Submitted status from one or more entries in the table, transitioning them back to Incomplete or Ready For Submission, based on the state of their contained requirement sets. Additionally, the Date of Submission field on the Submission form will be cleared.
Approve Submission
This will apply the Approved decision status to one or more entries in the table. Applying this status will set the value of the submission or amendment’s Decision field on their corresponding submission form.
Reject Submission
This will apply the Rejected decision status to one or more entries in the table. Applying this status will set the value of the submission or amendment’s Decision field on their corresponding submission form.
Delete Che
Deleting a Submission or Amendment that contains a requirement set will disassociate the requirement sets from the submission. If the requirement set was added at the study level for the submission it can still be viewed from the Manage Requirement section.
To Delete
To delete a submission, the Active Status must be set to Active Only.
- Select the checkbox by the Submission record.
- Select Delete Checked in the Choose An Action Press-Go dropdown.
- Select Delete button on the Confirmation Page.
To Restore
To restore a deleted Submission, the Active Status must be set to Deleted Only.
- Select the checkbox by the Submission record.
- Select Restore Checked in the Choose an Action Press-Go dropdown.
- Select Restore Button on the Confirmation Page.
Actions
The Actions Menu can be expanded by clicking and contains the following options:
Add New Amendment
By clicking the Add New Amendment, you will be presented with a blank submission form to be completed. When this form is saved, the new amendment will be added to the study.
Add New Submission
By clicking the Add New Submission, you will be presented with a blank submission form to be completed. When this form is saved, the new submission will be added to the study.
Exports
By clicking 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.
Need more help?
Please visit the Fountayn Contact Information page.