Scenario

Before a clinical trial can begin, an ethics committee needs to review and approve the relevant documents.

Video

Click here to see a video demonstration of this use case. You can change the language for the video by clicking on the Language icon in the upper right corner.

Typical Issue Life Cycle

  1. The Sponsor submits the Submission for Approval form to the ethics committee via the JSM portal.

  2. An agent adds as many copies of the Documents Review form as needed to the request. 

  3. The Ethics Committee reviews each of the documents and records their recommendations on the corresponding form.

  4. An agent changes the status to PENDING CHANGES, and sets the review forms as external so the sponsor can see the results of the committee's review.  

  5. The Sponsor makes the requested changes and resubmits the documents.

  6. The Committee reviews the updated documents and either requests more changes or approves the document. The agent records the results on the Final Approval form.

  7. When all documents have been approved, the agent submits the Final Approval form. A workflow validator prevents the issue from being changed to the WORK COMMENCED status unless the Final Approval form has been submitted.

  8. The issue's status changes to WORK COMMENCED and the study can begin.

Key Actions

  1. Set up a workflow validator that prevents the issue from being changed to the IN PROGRESS status until the Final Approval form has been submitted.

Workflow

You can download this workflow from the Atlassian Marketplace.

Forms

Unique Features

  • Forms can be set to lock on submission so that the responses of the review committee cannot be altered. 

  • Once the committee has completed it's a review of a given document, the agent can set the completed form to External, making the committee's feedback available to the Sponsor.

  • Form validation on the Final Approval form prevents submission until all required documents have been marked as approved. A workflow validator prevents the issue from changing to the In Progress status until the Final Approval form is successfully submitted.

Submission for Approval

This form is available in the ProForma templates side bar.

Document Review

This form is available in the ProForma templates side bar.

Ethics Committee Final Approval

This form is available in the ProForma templates side bar.