Requesting Study Approval

You can submit a fully defined study for approval by a reviewer.

Before you begin: Review the study and ensure that you provide all required information and define all the time points, storage conditions, and tests.
See Also
Approving a Study
About the Lifecycle of a Study
  1. From the Home Page, open the study for which to request approval.

    For more information, see Opening a Study.

  2. Optional: Select the Lifecycle and Status tab.
    This shows the current lifecycle state of the study.
  3. Review the study's members, materials, storage conditions, time points, tests, and amounts.

    For more information, see Reviewing a Study and Defining Study Members.

  4. Click Request Approval.

    Tip: If the Request Approval command is not available, check that the study includes all the required information. For example, ensure that a manufacture activity is specified for every new lot requested.

    The form to request approval of the study opens. For more information, see Study Signature Form.

    For each lot, if the material amount required is greater than the available amount, a warning requires confirmation before you can proceed.

  5. Select one or more members of the study to approve it.

    The listed potential approvers all have review rights, but you cannot select those who have edited the study. If you need to select a study member or other user as an approver, add them or edit their rights for the study. For more information, see Defining Study Members.

  6. Choose the reason for signing the study and add a comment.
  7. Enter your password to confirm that you are formally providing your electronic signature.
  8. Click Sign.

The Summary tab for the study is shown. The Lifecycle and Status tab shows that the study is now in the Pending approval state.