Create a signature group

  1. At the bottom of the Project Explorer, click the Study Information (study information icon) button.
  2. Expand the study folder, and select Administration.
  3. Select the Signature Groups tab.
  4. In the top-left corner of the tab, click the Create signature group(s) icon.
  5. In the New Signature Group dialog box, enter a name and description for the signature group and the following information:
    • Invalidation Level—When to invalidate a signature when a hidden item on a form is imported from Oracle Central Coding after it has been signed.
      • User―Invalidate the signature if the signer can see the item being imported.
      • Group―Invalidate the signature if at least one signer in the signature group cannot see the item being imported.

      Note:

      This attribute only applies to data items being imported from Oracle Central Coding. Any other edits made directly to data items in Oracle InForm will still invalidate the signature.

      Tip:

      To prevent signature invalidation when Oracle Central Coding updates an item, set the invalidation level to User.
    • Reset Form State—Select to indicate whether associating a new signature group with a signed form resets the state of the form to Unsigned in InForm. The original signatures remain valid, but the form requires a signature from a member of the newly associated group.
    • Type—Type of object the users in the group can sign.
      • CRB—Case Report Books.
      • CRF—Forms.
      • CRB, CRF—Case Report Books and forms.

      Note:

      If a Visit Approval form is created, you have to add it to one of your CRF Signature Groups.
  6. Click Add and select the checkboxes of the forms you want to add.
  7. Click OK.
  8. Next,Enter translation text for a signature affidavit .