Summary

This article covers how the add submission screen can be used for both submissions and amendments that have been added to the study. 

Table of Contents

The Add Submission screen is a form that is used for both submissions and amendments that have been added to the study. This form collects high level information regarding the submission, which study sites are contributing to it, when a decision is expected to be made, and any documents or letters that are associated with it.

This is also the screen where study requirement sets can be added, tracked, and accessed. Each regulatory submission has a completion status that is affected by the completion of any requirement sets that are stored within it. This allows us to observe when the documents and necessary data for a submission have been collected and whether they are ready to be submitted.

Access Add Submission Screen

The Add Submission form can be accessed by clicking “Add New Amendment” or “Add New Submission” from the Manage Submissions screen.


The Add Submission form for existing submissions or amendments can be accessed in one of two ways. The first is by clicking the associated link in the Name column of the Submissions Manager Table.

 


The second is by accessing the submission or amendment from the study navigation tree by expanding the Regulatory Bodies sub menu, and then expanding the sub menu for the study regulatory body the submission is associated with.

 

 

Default Fields

The Add Submission form contains the following fields by default:



Name

The Name field is a text field used to identify the submission. This is a required field and will fire a black alert, preventing the user from saving if skipped. The field’s visibility settings cannot be changed.

Regulatory Body

The Regulatory Body field is a dropdown select that allows you to choose from among regulatory bodies that have been added to the study. This identifies for the system, which regulatory authority is associated with the submission. This is a required field and will fire a black alert, preventing the user from saving if skipped. The field’s visibility settings cannot be changed.

Associated Sites

This dropdown select is used to identify which study sites are contributing to the completion of a given submission. By clicking this field you can select from sites that are reporting to the submission’s regulatory authority, and select which of those are responsible for contributing data to a given submission. The field’s visibility settings cannot be changed.

Date of Session

Date of Session is a date field that tracks when a regulatory authority will convene to approve or reject regulatory submissions. The field’s visibility settings cannot be changed.

Expected Date of Decision

Expected Date of Decision is a date field that is used to track when the study is expected to receive a decision from the regulatory authority associated with the submission. The field’s visibility settings cannot be changed.

Decision

Decision is a locked text field managed by the system. When a decision status is applied to a submission via the Submissions Manager, this field will be populated with the result. The field’s visibility settings cannot be changed.

Documents and Letters

Documents and Letters is a file upload table that allows for the collection of any documents or communications that are relevant to the submission. The field’s visibility settings cannot be changed.

Comment

The Comment field is a multi line text field that can be used to collect any additional information regarding the submission or amendment. The field’s visibility settings cannot be changed.

Date of Submission

The Date of Submission field is a date field that is used to collect the date provided when using the Submit action for the Submissions on the Manage Submissions screens. If the Remove Submission Status action is subsequently used, the field will be cleared. If the Date of Submission field is manually updated after using the Submit action, the updated date value will be displayed when hovering over the Submitted status icon in Manage Submissions.

Note: This field was added to the Submission form configuration in the 14.6 release. The configuration must be released to production to add the field to CTMS in Secure. When released, the field will automatically populate for Submissions previously submitted.


Requirement Sets Table

The Requirement Sets table displays any requirement sets that have been added to a submission. These are the components of a submission where documents and related information that is part of a submission can be collected.


The table is basic, with each set having a name, a status, and a delete icon. By clicking the name, you can drill down into an individual requirement set. The Status column displays the overall completion status of the set, and clicking the delete icon will present you with a confirmation dialog to delete the set.

 

Adding Requirement Sets

Requirement Sets can be added to a submission in one of three ways, all of which are found in the Actions Menu.
The “Add New Set” and “Share Existing Set” actions are described in the Fountayn Knowledge Base section Adding and Configuring Requirement Sets, and it is recommended that you read this section before performing study level regulatory functions.

Adding Standard Requirement Sets

By clicking “Add Standard Set” in the actions menu, you will be presented with a dialog to choose from available standard requirement sets. These are common components of submissions that have been templated for repeat use in new studies. They are configured from the global Regulatory Manager, and can be changed there.


By selecting a value from the Regulatory Category menu, you may choose from standard requirement sets that have been saved for the regulatory body associated with this submission. Selecting one or more standard requirement sets and clicking the Save button, will quickly add those sets in their current configuration to the study.
You can add sets from multiple categories by first selecting those desired from one, then changing the category selection and choosing more. The sets selected in the Standard Requirement Set field will not be lost by switching categories.

Actions

The Actions Menu can be expanded by clicking and contains the following options on the Edit Submission screen:

Download Documents

Provides the user with a zip file of all documents uploaded to all requirement sets in the submission.

Note: The following actions are described in detail in the Adding and Configuring Requirement Sets section, and it is strongly recommended that this be read.

Add New Set

Provides the user with a blank study requirement set form to add a new requirement set to the submission or amendment.

Add Standard Set

Displays a dialog for the selection of standard requirement sets that have already been template for the regulatory body the submission is being created for.

Share Existing Set

This action displays a dialog that allows the user to select from existing submissions and requirement sets. By selecting requirement sets to be shared, the user can choose components of other submissions that will be used in the submission being modified. Once this relationship is established, the system can provide simultaneous data entry across shared sets


Importing Submission Information

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This information can be imported as part of the Study import. Click here for more information.


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