Enhancements to signature configuration and management

You can now make casebook signature optional, making it possible to use form and visit level signatures without having the subject level signature required as well. Additionally, you can now analyze signed status at a more granular level in Oracle Clinical One Analytics.

Make the casebook signature optional

To control whether the casebook signature is required or not, a new Required toggle is available in the Signature Configuration tab of the study settings. This toggle displays in the casebook signature tile for each mode, allowing you to control whether to use casebook signatures or not in any study mode.

There is no new permission associated with this enhancement. Users assigned with the existing Manage Signature Settings permission can use this toggle as part of the Casebook signature configuration.

To preserve existing functionality, this toggle is ON by default. As you turn the toggle OFF, users don't loose the ability to sign data at the subject level, but casebook signatures become optional and are not taken into account in the overall sign status of each element (form or visit).

Note:

When this setting is updated, either from ON to OFF or vice versa, this change in configuration is handled asynchronously. This means it may take up to 60 minutes for new or updated signature requests to apply in your study.

There is a difference between the sign status applicable to every signature configuration (at different levels) and with the overall sign status. The overall signed status is persisted in the system and flows to Oracle Clinical One Analytics (see the section below). For example, a given form can be signed as part of the form or visit level signature or as part of the casebook signature, and depending on the configured signatures the overall sign status may be different. This depends on the specific scenario but, in general, the following rules apply:

• Making the casebook signature optional impacts the overall sign status at each level:
  • If no other signature configuration applies (like at the form or visit level), the item level signature is driven by the casebook signature. This means that, even if it is optional, if the casebook is signed so does the item and this becomes the overall sign status for the item.
  • If another signature configuration applies, the item level record is not driven by the casebook signature configuration. This means that if an item is signed as part of the casebook signature but not as part of the required applicable signature configurations, the overall sign status remains as unsigned or never signed. The item only changes to a signed status if signed at all the applicable signature configurations (disregarding the optional casebook signature).
  • When all required signatures have been completed, the status of those forms, visits, and the overall subject status is Signed. The other visits and forms that don't have a defined signature configuration can still be signed via the optional casebook signature, but their signature status (signed or unsigned) does not impact the signature status for the visit or subject.
• For the signatures applied at either the form or visit level or as part of the casebook signature, there is a normal roll-up behavior. This is that if a given element (subject, visit, or form) is signed, all the child elements within it are signed as well, and if an element is updated and becomes unsigned all parent elements also become unsigned.

You can find more information on signature configurations in the Sponsor and CRO User Guide after the assessment environment upgrade.

The ALLSIGNED data element

With the new option to use form and visit level signatures only (without requiring the casebook level signature), having a data point to report on signatures and customized affidavits for all signatures becomes more necessary. So, as part of these enhancements, a new ALLSIGNED data element in Oracle Clinical One Analytics datasets provides the overall signed status at all levels:

• At the visit level in the Event folder of the Blinded and Unblinded Subject Event datasets.
• At the form level in the Form folder of the Subject Forms dataset.
• At the item level in the Item folder of the Subject Form Items dataset.

This new data element can hold any of the following values:

Status	Description
SIGNED	All possible signatures relevant to this object have been applied and are valid.
PARTIAL_SIGNED	Some signatures relevant to this object have been applied and are valid. For this status, some signatures may be applied and active, while others are not yet applied or invalidated (unsigned). If at least one but not all signatures applicable to this object is in the SIGNED status, the object is considered partially signed.
UNSIGNED	All signatures relevant to this object are invalidated or null. Signatures that have not been applied are null. If at least one signature is in UNSIGNED status, and there are no applicable signatures in the SIGNED status, the object is considered unsigned.
<null>	No signatures relevant to this object have been applied.

The existing SIGNED data element remains unchanged in all four datasets, holding information of the signed status at the casebook level for the subject. You can find more information on these data elements in the Analytics User Guide after the assessment environment upgrade.

Impact on reports

This new setting to control whether the casebook signature is required or not, is available in the following reports:

Report	Type of change	Description
Study Settings report	New column	New Signature Required column in the Signature Configurations tab. This column displays the following for Casebook signatures: On Off Displays N/A for Form and Visit Level configurations.
Study Design report	New column	New Signature Required column in the Signature Configuration section. This column displays the following for Casebook signatures: On Off Displays N/A for Form and Visit Level configurations.

For the impacts on other downstream applications, see unresolvable-reference.html.