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Compliance Use Case: Ethics Committee Approval

by Jenny Choban on September 17, 2019

Team: Compliance

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

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Typical Request Life Cycle:

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

  2. Upon submission, the issue changes to the Under Review status and four forms are automatically added to the issue:IRB_workflow (1)

    Protocol Review
    ICF Review
    Investigator's Brochure Review
    Final Approval 

  3. An agent manually adds one or more Supplemental Documents Review forms as needed. 

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

  5. An agent then sets the forms as external so the sponsor can see the results of the committee's review.  

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

  7. 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.

  8. When all documents have been approved the agent submits the Final Approval form.

  9. The issue's status changes to In Progress and the study can begin.

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.

Forms used:

  • Submission for Approval
  • Protocol Review Form
  • ICF Review Form
  • Investigator's Brochure Review Form
  • Supplemental Documents Review Form
  • Final Approval Form

Products:

  • Jira Service Desk (using JSD Portal)

Key Actions

  1. Set up JSD automation to automatically add the Protocol Review, ICF Review, Investigator's Brochure Review and Final Approval forms when the issue is created.

  2. 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.


Interactive Tutorial

14 STEPS

 

1 ProForma makes it easy to bring a variety of processes into Jira, without requiring custom fields or complex configurations. This video demonstrates an ethics committee approval process with ProForma and Jira Service Desk.

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2 A Clinical Trial request type has been created, allowing the sponsor to upload and submit all of the documents needing approval.

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3 A ProForma form which has been published to the JSD portal collects the relevant information. 

When the sponsor submits the form...

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4 An issue with all of the uploaded documents is created.

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5 The forms that the ethics committee needs to complete have been automatically added to the issue.

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6 Additional forms can be added manually as needed.

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7 The committee reviews the submitted documents and records the results on the indicated form.

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8 The form allows the committee to approve the document as is, or request changes.

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9 After completing the review, the review form is set to External so the sponsor can see the committee's comments.

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10 An additional Submission for Approval form is added for the sponsor to submit with the revised document.

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11 The sponsor can now access the completed ICF Review and the new Submission form via the portal.

The sponsor makes the requested changes and resubmits the document.

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12 Once all of the required documents have been approved, the committee completes the Final Approval form.

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13 A workflow validator ensures that the Final Approval form is complete and submitted before the issue transitions to IN PROGRESS  and the study can commence.

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14 If you would like more information, visit us at www.thinktilt.com or look for ProForma in the Atlassian Marketplace.

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Here's an interactive tutorial for the visual learners

https://www.iorad.com/player/1596024/Proforma-Use-Case-–-Clinical-Trial-Ethics-Approval