Register a Clinical Trial

Overview:

Registration with the Center of Excellence is required for all clinical trials on the Morgantown campus that meet the NIH clinical trial definition. Follow the steps below to create a new COE registration.

Create a Clinical Trials Registration :

  1. From your WVU+kc dashboard, click on CoE in the menu at the top.

  2. Choose Create Center of Excellence Registration from the menu options. A page displaying the mission of the CoE and the requirements for registration, as well as CoE contact information will appear.

  3. Read through the information page, including:

    • Mission statement,

    • Requirements for Registration,

    • NIH Clinical Trial Definition, and

    • Key Contacts at the CoE.

  4. Click Continue at the bottom of the page to proceed. The Clinical Trial Registration form will display, showing the Center of Excellence Registration tab. Complete the Required Information section first.

  5. In the Basic Information sub-section, you are asked to verify that the study meets the NIH definition of a clinical trial based on four criteria. You can only submit a registration for studies that meet the definition. Review the four questions and answer Yes or No.

    • If you select No, the form will close.

    • Click Yes to continue.

  6. Click the search icon in the WVU IRB Lookup field to locate your IRB protocol. If this study does not yet have a protocol, click the Create button to submit a protocol document in WVU+kc.

Note: If this study does not yet have a protocol, you can quickly start one by clicking the Create button to start a new protocol document in WVU+kc. On the new page, just supply the: Description, Protocol Type, Title, Principal Investigator, and Department or Lead Unit. After you save the protocol, it will be assigned a Protocol Number (in the header area), which can be used to search for the protocol in the WVU IRB Lookup on this registration.

  1. Complete one or more fields on the search page to identify the protocol. For example, enter text for the Protocol #, Title, or Investigator fields.

  2. Click the Search button at the bottom of the page.

  3. Locate the correct IRB Protocol in the search results. Click the Return Value link in that row to populate the protocol information. The WVU IRB Lookup info, Title, PI info, and Department will appear on the form.

  4. You can also link the WVU+kc Proposal document to this clinical trial. Click the search icon to look for your proposal. You must have permission to view or edit the Proposal in WVU+kc to see it on the Proposal Lookup page.

    1. On the Proposal Lookup page, click the drop-down in the Proposal Category Type field to select the proposal type. (required)

    2. Complete one or more fields on the search page to locate your proposal. For example, enter text for the Proposal #, Project Title, or Principal Investigator fields.

    3. Click the Search button at the bottom of the page.

    4. In the search results, locate the correct Proposal Development document, and click the Return Value link to fill in the field. The WVU Proposal Lookup and Title info will populate.

  5. Click the Show button to display the COE Questions section of the registration form.

  6. Answer each of the questions in the COE questionnaire to the best of your abilities. You can hold your mouse over the help icons (question marks) if you need clarification.

  7. Click the Save button at the bottom of the page. This will enable the COE Attachments section.

    • After saving, you will see a confirmation message at the top of the page, indicating that the ‘Document was successfully saved’.

  8. Click the Show button in the COE Attachments section, where you will upload the Protocol document and Clinical Trials Agreement.

  9. In the Upload Protocol field, click the Upload button. The Protocol document is a required attachment.

  10. On the Add Protocol screen, you may either click the Upload a file button to browse your computer for the protocol document, or you can drag-and-drop the file into the area with the dotted line. You will see the file name appear below the drag-and-drop area.

  11. After you have selected the file, click the Finished button to attach it to the COE registration.

  12. Next, upload the Clinical Trials Agreement for this study. Click the Upload button in the second attachments field.

  13. On the Add Agreement screen, attach the agreement by clicking the Upload a file button, or drag the file into the dotted line - then click Finished to attach the file.

  14. You are now ready to submit the registration. Click the COE Actions tab at the top of the screen.

  15. In the Submission section, click the Submit button to send this clinical trials registration to the Principal Investigator for approval, which will forward it to the Center of Excellence for review. If you are the PI, the registration will go directly to the Center of Excellence.

Note: You can see each step of creation, submission, and approval by viewing the History section on the COE Actions page.

Details

Article ID: 94810
Created
Fri 12/20/19 10:15 AM
Modified
Wed 4/22/20 4:47 PM