CERES: Create and Submit a Clinical Trial Agreement

Create and Submit a Clinical Trial Agreement

Note: The attachments contain a job aid related to this article.

After the related funding proposal is approved by the necessary parties and reviewed by Sponsored Research (SR), the Research Administrator (RA) can create the Clinical Trial Agreement (CTA) following the steps below.

To Create a Clinical Trial Agreement (CTA)

1. From the funding proposal workspace, click Create Agreement.
2. On the Create Agreement activity form, under “Select an Agreement Type to create” select Clinical Trial Agreement and then click OK.
3. From the funding proposal workspace, click the Related Projects tab and click the agreement name to go to the workspace.
4. From the agreement workspace, click Edit Agreement to open the SmartForm.
5. Complete all required fields on the Agreement Upload page. For question 3, if the agreement document has already been drafted by the sponsor, you can attach it by clicking the Upload button. However, if SR will create the first draft of the agreement using a Northwestern template, check the First draft to be generated internally? box instead.
6. On the General Information page, RAs should list themselves as an Agreement Collaborator under question 6 (in addition to being listed as the Primary Contact) to ensure they receive notifications related to this agreement.
   • Note: Primary Contacts do not receive notifications from CERES as part of the standard agreement workflow, however Collaborators do. The only email notification that Collaborators will not receive is if clarifications are requested on the agreement. This notification will only send to the PI and Proxy. However, when the agreement is in a Clarification Requested state, it will show in the CERES inbox for the Primary Contact, Collaborators, and PI/Proxy, so you can still take action to address the requested clarification.
7. After completing this page, click Continue and enter CTA information in the following pages.
   • Important! Do not complete the “Negotiation Information” page as this section is only to be filled in by Sponsored Research. Move on to the next page by clicking Continue.
8. On the last page, follow the completion instructions and then click Finish.
   • Note: Failure to fill out correctly and completely will cause delays and the agreement will be routed back to the department​.

When you click Finish from the SmartForm:

• You have not yet submitted the agreement. The workspace of the created agreement displays, and the workflow state is Pre-Submission.
• The agreement will stay in your inbox, and you can continue to edit the agreement until you submit it for processing.
• The History tab on the agreement workspace will log who created the agreement.

Note: By default, the person who creates an agreement is assigned as the Primary Contact in the system. The Primary Contact can be changed, and if that happens, the person who creates the agreement will:

• See the agreement in My Inbox only during the Pre-Submission state.
• No longer have read and write permissions on that agreement.
• Not be able to create amendments for the agreement.

To Submit a Clinical Trial Agreement (CTA)

1. Before submitting the CTA, verify that the related funding proposal has received department approval and is in Specialist Review by navigating to your Dashboard, then click the In Process tab. Alternatively, you can navigate directly to the funding proposal from the agreement workspace by clicking the proposal name in the "Related Projects: tab.
2. On the In Process tab, funding proposals in Specialist Review will appear under the “Proposals in Process – Any State” tile. Click on the tile to view the funding proposals and look for the proposal related to the CTA. Verify the state is Specialist Review.
3. After the funding proposal has received department approval and is in Specialist Review, from the agreement workspace, click Submit.
   • ☆ Tip: Before submitting, you can verify you’ve completed all required SmartForm fields by clicking Edit Agreement on the workspace and then at the top of the left navigation panel, click Validate.
4. Click OK to accept the statement and route the Clinical Trial Agreement into the workflow.

When this Submit activity is executed:

• The agreement advances to the Unassigned state. The appropriate Sponsored Research team will assign a team member to oversee the agreement through the review, negotiation, and signing process​.
• The activity will be logged under the History tab on the agreement workspace, showing who submitted the agreement.
• The PI and Proxy will be notified throughout the workflow if clarification is needed. The PI, Proxy, and Collaborators will be notified once the agreement language is approved. When the agreement is activated, they will also receive a notification with a link to the fully executed agreement.