1. Information for CRO and Sponsor Users
  2. About submissions

11 About submissions

Note:

This section describes working with non-EU submissions. To see detailed information about creating and managing study level, EU submissions, see About study level submissions.

The submissions modal

The submissions modal makes it easy for you to complete required and important activities. The modal (see image below) includes a static header that identifies the study and country as well as scrolling modal body design.

When appropriate, Oracle Site Activate groups related submission activities in a single, tabbed modal. For instance, a submission modal may include the submission tab, as well as one or more package and/or subcommittee tabs when these items exist for that submission. The Actions menu in the header section of the Submissions modal includes options to discontinue or reinstate the submission and add additional packages, when necessary.

The Activities tab is the default view, and required activities are listed horizontally below the Activities tab. You can easily navigate from one activity to another by click, and your selected activity will be underlined in blue.

The modal’s “Info” tabs include a Details area where you can enter data into configured metadata fields (e.g., Version ID, reason, description, agency, etc.). Below the Details area is a Submission dates area where you can plan smart submission milestones and adjust the eye button to display/hide milestones on the milestone calendar. The Info tab also includes sections for Files and any configured TMF data.

Within the modal body, you'll have date, file attachment, and notes options to the left. The shaded panel, to the right, includes an enumerated list of Required actions, as well as any Important fields.

The lower section of the modal includes Related activity history and Blocked activities sections, if applicable.

Submissions modal with related submission package tab

Using workflow wizard and submission activity widget

Oracle Site Activate is configured to create activities that help your study team manage and track study country and site submissions. During initial setup, your organization worked with Oracle to identify required submission documents based upon known regulatory requirements and your organization’s standard processes.

You'll use the workflow wizard to generate the activities required to track and manage each submission. Then you'll use the submission activity widget to record key dates and track the list of required documents.

Study team members plan and track submissions

Planning submissions

You or another member of your study team may receive an alert to plan the submission. Start by defining key dates, for example package date is required. The package date can be edited, if necessary, and Oracle Site Activate prompts the user who is updating the date to enter a reason for the date change.

Submissions can be configured to have expiration dates, which may be set to required, if desired by your organization. Submission expiry notification (default 90 days) may optionally be set as well. If expiration does not apply, Oracle Site Activate users may check a “no expiration date” check box within the Submission modal. Once the submission is completed, the expiration date field is no longer editable.

At any time, you can view the submissions widget Planning or Tracking tabs and see the status of documents being tracked for the package.

If you need to replan a submission, and you attempt to remove one or more documents that are in first review or final approval status, Activate will display a warning message. The submission package planning page displays the warning if you:

  • uncheck a document that is already in an approved status. The message is: "This document is in first review or final approval for this package. Are you sure you want to remove this document?"
  • click the deselect all check box at top of the page, and one or more of the previously selected items is already in an approved status. The message is "One or more of the below documents is in first review or final approval for this package. Are you sure you want to remove this document?"

Within the warning message pop-in, you can confirm removal by clicking "Yes," or "Cancel" the removal action.

Creating additional packages and adding subcommittees

If you need to submit additional documents later, create a new submission package to track them. To define the new package, you will repeat the steps you performed to create the initial package.

To help you differentiate and track key dates and documents for subcommittees, you can also add a submissions widget to help you track those submissions.

In the packages section, click "plan this submission package" to define a package date and select study, country, PI/site, and PI/site documents as appropriate to the new package.

Submission package planning interface

Tracking submissions

Immediately after planning is complete, you or another team member who is responsible to track the submission receives an alert as a reminder to mark the date that the package was submitted. That alert remains on your to-do list until you enter a completion date.

During planning, you or another team member entered a baseline date for each of the submission’s activities. If you learn that a submission date changes, you can re-plan the submission date. You can re-project dates as many times as needed. From the submission Tracking tab’s Submission information section, you can specify the submission type (e.g., initial, amendment, etc.), version ID, and reason why the submission is being made.

If your organization configures Oracle Site Activate to do so, you can upload the submission approval letter so that it can be stored with the submission in Oracle Site Activate.

Tracking submission dates

To easily track key submission dates, you can also enter baseline, planned and actual submission dates on the widget and at the top of study country and site detail pages.

The newest milestones sort to the left on the timeline and oldest sort to the right. Date and sort order are determined as follows:

  1. If an Actual Date is present on a submission, that date will be used as the sort date for that submission.
  2. If no Actual Date is present on a submission, the Planned Date will be used as the sort date for that submission.
  3. Submissions with no planned dates will display at the far left of the timeline.

    A maximum of 50 submissions will be displayed in the timeline. Submission milestones will be removed from timeline display based on the date and sort order described above. The oldest planned submission milestones (i.e., those that sort to the far right on the timeline) will be removed from display first as new milestones are added.

Submission date timeline and Submission placeholder filter

Correct sites included in a submission

If you have a role with data corrections permission, you can correct the sites included in a submission. After a submission has been approved, a new “Sites approved in submission” subtab lists all sites that were included in the submission’s “Define package” step. The site grid lists PI/Institution name, as well as the site number, site network, and status.

While the new tab is visible to all users after submission approval, only those users who have data corrections permission may uncheck sites to remove them from the submission approval. After site removal, the site will still be included in the initial submission and will still have an associated milestone; however, the site will no longer be approved for this submission.

Sites approved in submission tab

Submission milestone modals list Items in package

You can quickly access a list of all items included in a submission package using the "Items in package" section in the Final Approval and Initial Submit submission milestone modals. Expand the section to view:

  • Submission package name
  • Item name
  • Item level (study, country, or site)
  • Item status
  • Item due date, if a date exists. This column displays only if one or more items have a due date.

Item names, as well as country and site names, provide hyperlinked navigation. For example, you can click an item name to open the document modal or click the country code to navigate to the country page.

Submission modal with Items in package section

Submission package file ordering

When planning a submission package, you can order the files included in the package export ZIP file. In the package placeholder, the “Define order for this package” hyperlink displays a pop-in where you can manually number file order. Each number can be used once, and when an item has no number, it will be ordered in the ZIP file alphabetically on item name and then by item number. The file will be ordered by manually numbered items first, followed by alphabetized items (e.g., 123ABC).

Define package file order

Publish Submission package files to eTMF

When enabled for your organization’s account, and when you have the required business role permission, you’ll see a button on Submission packages that allows you to trigger sending Submission package documents to an eTMF from within the package itself. The Send to eTMF button is active only when the submission package is approved. Otherwise, it is inactive (grayed out).

When you click Send to eTMF, Activate sends any files in the submission package to the eTMF endpoint(s) configured for your organization’s account or study. You can click the button only once per package; after you send the files, the button no longer displays, and the text “Sent to eTMF” with the date displays instead. If necessary, you can retry messages on the Event Message page or via API if you have a business role permission that allows you to do so.


Send to eTMF button in completed package Documents in Package tab

This functionality includes additional fields in the eTMF publish messages that include information about the submission package itself. This ensures the files in each publish message can be stored in the appropriate eTMF location. When you click Send to eTMF in the approved package, the publish message includes a submission_package element with the fields below, which are populated with values where available:

  • package_name
  • protocol_version (inherited from the submission)
  • submission_type
  • submission_category
  • package_version_id

Note that by design eTMF messages generated outside of the manual Send to eTMF flow described above do not have the submission_package element.

Using smart submission management

You can quickly view and update submission dates from the submissions details page; in the top navigation bar, click or hover over More, then select Submission details. Click edit to enter baseline and planned (re-projected) submission dates.

Smart submission management

Managing a submission agencies list

Your organization has the option to upload a CSV format file containing the different submission agencies you may work with across countries. When uploaded, the agencies are available for users to select in an “IRB/EC/RA” type-ahead selection field in country and site level submissions.

You must have the appropriate business role permission to upload the CSV agency file. When you have this permission, the top navigation’s More menu includes a Manage submission agencies option.

Upload a list of submission agencies

The CSV upload file must include three columns in the following order:

  1. agency_id - (100 character maximum)
  2. display_name (255 character maximum)
  3. active (true/false)

Note that agency_id is a unique ID for each submission agency. If the ID already exists in Oracle Site Activate, the existing record will be updated (i.e., update either/both display_name and active). If the ID does not already exist, Oracle Site Activate creates a new agency record.

To determine the agencies that already exist in the system, you can download the current list to a CSV using the Export to CSV option on the Manage submission agencies page.