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Book Contents
Create a signature group
  1. At the bottom of the Project Explorer, click the Study Information (Study Information) 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 modified.
      • User―Invalidate the signature if the signer can see the item that changed.
      • Group―Invalidate the signature if at least one signer in the signature group cannot see the item that changed.

      Tip Tip: To prevent signature invalidation when 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 the signature affidavit.
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