COE reviews will be completed as an agreement and will be completed along with the clinical trial agreement (if applicable) with which it is associated all in one record. The COE/CTA process will be unique to the other agreement types because they will always be initially created by a PI or their designee as opposed to the Clinical Research Agreement Office.
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.
From the Dashboard, click the Create dropdown then the Create Agreement button.
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. Agreement manager/Principal investigator
2. Primary contact
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 you upload a draft here and Agreements office staff subsequently generate or upload a draft, their document will automatically replace the one you uploaded on this page..
4. Project Title or internal reference number: Clinical Trial Agreement - <Your Name or Initials>
5. Agreement type: Clinical Trial Agreement
6. Description
7. Supporting documents: Add the Supporting Document PDF file provided with this course.
8. Sponsor Deadline Date: Select the deadline date
General Information Page
On this page, you can enter the data provided or make up your own data. Do not use real data.
1.Contracting party: Select the contracting party
2. Contracting party contact name: Type the contact name
3. Contracting party contact e-mail: Type the contact e-mail
4. Contracting party contact phone: This is optional but you can type the contact phone
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: Add any person
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
WVU IRB Number: Enter the values.
WVU IRB Title: Enter the values.
COE Review Additional Information
On the COE Review Additional Information page, enter values.
CTA Agreement Information
On the CTA Agreement Information page, enter the values.
CTA Additional Information
On the CTA Additional Information page, enter the values.
Completion Instructions Page
Read the instructions on this page.
Click Save.
Click Validate on the left to ensure you did not miss any required fields. If you did, update the required fields.
When done fixing any errors, click Exit on the navigation bar or Finish if on the last page.
The next step is to submit the agreement for review.
Return to the Dashboard.
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.