About signature configurations

Learn more about creating signature configurations.

As a sponsor user, your study may encounter different scenarios where a signature is required, such as signing a Serious Adverse Events form, adjudication forms, completed visits, and forms that capture certain protocol deviations. By creating custom signature configurations, you can allow sites to sign off at the form or visit level for given forms and visits using customized affidavits.

What sponsor users must know

Before you begin your work with signature configurations, consider the following to assure you approach your task properly:

• You must be assigned the Manage signature settings permission in order to create and edit signature configurations.

  Note:

  Only roles with permission to sign will appear in the configuration drop-down list.

  Template users will not appear in the drop-down list for form and visit level signatures.

• Signature elements on the Study and Subject homepages are hidden by default for existing studies. In the Study Settings, selecting Yes for the Display signature elements for site staff and sponsors option enables the Signature widget () to display in Production mode, while the Signature Request side panel appears in all modes.

  Note:

  It is not possible to go back and select No for the Display signature elements for site staff and sponsors option once Yes has been selected and saved for the corresponding mode.
• Every form that has been created is available in the Forms list when creating a signature configuration, regardless of whether they have been assigned to a visit or not.
• To add more than one combination of an affidavit and role(s) for a given set of forms or visits, you must create an additional signature configuration for each combination.
• If a new visit is named the same as a deleted visit, both appear as options in the Signature Configuration.
• Modifications made to a signature configuration are applied to unsigned data and data that has never been signed, but does not affect signed data unless it becomes unsigned.
• If more than one role is selected in a signature configuration, a user assigned any of the selected roles can sign and fulfill the signature requirement.

  Note:

  If two roles are required to sign, then two signature configurations are required.
• When removing signature related permissions from study roles, be aware that if a role is still referenced in a signature configuration they no longer have permission to sign, the Sign option will still be available, but they will receive an error when attempting to sign.
• When a role referenced in a signature configuration has been retired, it will not be removed from the signature configuration, but the role will no longer have the ability to sign the data.
• Once a signature's target date has been reached or become overdue, you have the option to trigger an email notification each day until the overdue signature is applied.

  For notification details, see the Signature request notification.

You can choose to create a signature configuration in your study in any mode (Testing, Training, or Production). For step-by-step instructions on how to create a signature configuration, see Create a signature configuration.