Signature groups

The InForm application uses the mechanism of signature groups to manage trial-specific requirements about who must sign a form or case book. During trial set-up, users who have rights to sign forms or case books are assigned to signature groups. A signing form is designated as requiring signature by a member of one or more signature groups. The meaning of the signature is included in the definition of the signature group.

For example, if both a PI and a CRA must sign a CRF, the trial can be set up so the PI is a member of the Responsible Party signature group, and all CRAs are members of the Reviewer signature group. A signing CRF requires signature by a member of the Responsible Party signature group (the PI) and the Reviewer signature group (any authorized CRA).

The InForm application tracks the forms signing status, and displays a list of required and applied signatures at the bottom of each form requiring signatures.

The Signature Status Details form provides details about signature status, the meaning of the signature, and the date which the form was signed. The Machine Name column displays the computer with which the user was logged on when signing.