Create and Submit a COE Review/Clinical Trial Agreement

To start, the PI or department administrator will create an agreement record and select COE Review/Clinical Trial Agreement as the agreement type. The PI/dept admin will fill out all of the fields on the SmartForm pages, with the exception of the application score on the COE Review Additional Information page, and then submit it for review.

If the submission is for an investigator-initiated clinical trial, the PI department name and email should be added as the contracting party, and the draft to be generated internally should be selected on the agreement upload field.

If not, PI initiated, there should be an agreement draft, which should be attached to the agreement upload page. The contracting party and contact should be from the CTA funding source.

When you create an agreement, you are required to complete a series of pages. The number of pages depends on the type of review required.

1. From the Dashboard, click the Create dropdown then the Create Agreement button.

2. Complete the pages by entering the following information. An answer is not required for every field. Click Continue to move through all the pages. 

Agreement Upload Page

1. Principal investigator: Enter yourself as the PI.

2. Primary contact: This field is automatically populated with the person who created the agreement but can be changed if necessary.

3. Upload agreement draft: If the agreement document has already been drafted, you can attach it to the Agreements SmartForm by clicking the Upload button. However, if Agreements office staff are going to create the first draft of the agreement, check the First draft to be generated internally? box instead. Agreements office staff will generate or upload a draft by running the Generate Agreement activity.

   Note: If the agreement document has already been drafted, you can attach it to the Agreements SmartForm by clicking the Upload button. However, if Agreements office staff are going to create the first draft of the agreement, check the First draft to be generated internally? box instead. Agreements office staff will generate or upload a draft by running the Generate Agreement activity.

4. Project Title or internal reference number: Enter the title or internal reference number

5. Agreement type: Select COE Review/Clinical Trial Agreement

6. Description: If applicable provide a description

7. Supporting documents: If applicable provide attach any documents

8. Sponsor Deadline Date: Select the deadline date

 General Information Page

• 1.Contracting party: Select the contracting party

• 2. Contracting party contact name: Enter the name of the representative from the contracting party.

• 3. Contracting party contact e-mail: Provide the email address of the contracting party contact.

• 4. Contracting party contact phone: This is optional but you can type the phone number of the contracting party contact.

• 5. Additional Contracting Parties: Indicate if there are other contracting parties involved in the agreement beyond the primary one.

• 6. Responsible department/division/institute: By default, this field displays the organization of the PI entered on the Agreement Upload page.​ If no value displays, then you must select a value.​

• 7. Agreement collaborators: List any collaborators who will have read/edit access to the agreement, or indicate none if not applicable.

• 8. Bilateral or Unilateral Signature: Identify whether the agreement requires signatures from both parties (bilateral), one party (unilateral), or unknown.

• 9. Is a Proposal Associated with This Agreement?: Specify if the agreement is associated to a funding proposal, and if so, use the Manage Relationships activity to establish the connection.

• 10. Does This Project Require an Agreement?: Confirm whether the project necessitates an agreement to proceed.

COE Basic Information 

1. WVU IRB Number: Enter a WVU IRB Number.

2. WVU IRB Title: Enter the WVU IRB Title. 

COE Review Additional Information 

On the COE Review Additional Information page, enter values in Q1-Q10. Leave Q11 blank.

CTA Agreement Information

On the CTA Agreement Information page, enter values in Q1-Q6.

CTA Additional Information

On the CTA Additional Information page, enter values in Q1-Q8.

Completion Instructions Page

• Read the instructions on this page.

3. Click Save.

4. Click Validate on the left to ensure you did not miss any required fields. If you did, update the required fields.

5. When done fixing any errors, click Exit on the navigation bar or Finish if on the last page.

6. Return to the Dashboard.

7. Confirm you met the success criteria below:

• The agreement you just created is in My Inbox on the Dashboard.

• The agreement is in the Pre-Submission state.

Manage Relationships

If the COE/CTA record is related to another agreement (such as a DUA) or a proposal/award, the agreement reviewer or PI/dept admin can use the Manage Relationships activity to relate it to the COE/CTA record. This will create a bi-directional, navigable link between the records.

1. Click Manage Relationships and search for a funding proposal or award record. You can search by typing the title in the Related Submissions search box.

2. Select it and click OK.

3. Navigate to the Related Projects tab and ensure the award is present.

PI Certification

1. Use the PI Certification activity to certify the agreement information is correct: I certify

To submit an agreement

1. Check if all the information is accurate and complete.

2. At the left of the workspace, click Submit.

3. Click OK to accept the statement and submit the agreement.

• 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.