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A pre-approval request allows you to submit a request to participate in certain activities, which is then reviewed before making a determination. You can only select one activity in a pre-approval request. If you have more than one activity that you need to request permission for, submit a pre-approval request for each activity.

To create a pre-approval request

  1. From the disclosure profile workspace, click Request Pre-Approval.

    Shows the Discloser Profile workspace wherein the Request Pre-Approval button is highlighted.
  2. Enter a name for this pre-approval request.

  3. Select the type of pre-approval request that you want to submit. The type of request that you select here drives the questions that you have to complete for this pre-approval request. Click Continue to move to the next page.

    Note: You can only select one type of request at a time. If you need to submit requests for more than one type, complete the details of the first type and then create additional requests.

  4. Complete the page and click Continue.
    Note: You must enter the description of the proposed activity before submitting the request.

  5. On the final page, click Finish.
    The newly created requests workspace appears.

Important! Clicking Finish does not send the pre-approval request for review. It remains in the Pre-Submission state. You can continue to edit the pre-approval request (Edit Pre-Approval Request button) until you submit it for review. When the study is ready for COI review, you must submit it using the steps that follow.

To submit a pre-approval request from the requests workspace

  1. From the Top Navigator, click COI and then click Requests.
    The Requests page appears.

  2. Click the All Requests tab.

  3. Select the pre-approval request that you wish to submit.

  4. From the requests workspace, click Submit.

    Shows the Requests workspace wherein the Submit link is highlighted.
  5. Click OK to agree to the terms.

To submit a pre-approval request from your disclosure profile

  1. From the Top Navigator, click COI and then click Disclosures.

    The Disclosure workspace appears.

  2. On the Pre-Approval Requests tab, select the drop-down menu in the Execute Activity column of the pre-approval request you wish to submit.

    Shows the COI Disclosure Profile workspace wherein the Pre-Approval Requests tab, Execute Activity drop-down menu and Submit are highlighted.
  3. Click Submit to submit this pre-approval request for review.

  4. Click OK to agree to the terms.
    The requests workspace appears. The pre-approval request is submitted and moves to the Review state.

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