Step 4k: Create a Visit Approval form (optional)

A visit approval form allows study designers to assign a visit level signature to signature groups. This is useful if data entered into CRFs needs to be verified as soon as possible after the visit is complete.

When creating a Visit Approval form, consider that:

• Visit Approval CRFs can be used regardless of other CRF signature groups.
• There can only be one Visit Approval form per visit.
• There are no restrictions on the type of visit (such as normal, dynamic, repeating, or common) a Visit Approval form can be associated to.

  Note:

  It is not recommended to set a Visit Approval for a common visit, as it is not a discrete timepoint.
• Common and Repeating forms cannot be set as Visit Approval forms.
• When a Visit Approval form exists in a visit, all other forms within that visit, except common forms, fall under the visit level signature. Any change to any of the forms within that visit will then invalidate a Visit Approval form previously signed in Oracle InForm.

  Note:

  If you are using visit approvals in your study and want the common form to be signed as well, it will need to have its own CRF level signature associated with it, as it is not part of the visit signature.
• You must create an item question for the Oracle InForm user to note whether the visit is ready for signature.
• Oracle recommends that you create a section level note describing the visit level signature.
• Creating signature groups that include Visit Approval can be done in the same way as with regular CRF signature groups.

To create a Visit Approval form:

1. At the bottom of the Project Explorer, click the Visit Schedule () button.
2. Right-click the visit where you want to add the Visit Approval form, select New, then select Form.
3. Enter a Title, RefName, and Description, and click OK.
4. In the Project Explorer, select the new form, and make sure the Design tab is selected.
5. Click the Properties tab, which appears on the right of the page by default.

   Tip:

   If you don’t see the Properties tab, at the top of the page, select View, and make sure Properties is selected.
6. At the top of the Properties tab, in the Oracle InForm section, click in the Special Forms field, and select Visit Approval.
7. Add the Visit Approval form or forms to the CRF signature group, along with any other CRFs that need to be signed.
8. Update the signature affidavit text as needed on a per language basis.
9. Complete the study build, validate the study, create a deployment package and deploy to Oracle InForm.