Sign data at the casebook level

If your study requires you to sign data for subjects at the casebook level then you must perform this task to ensure that the data is accurate. However, you can still sign a subject's casebook when casebook signatures are optional.

You need the Approve and sign subject data permission to sign a subject's data. All started visits can be signed, even if not completed.

Note:

Any change to subject data—including entering or editing data, adding a new repeating-form instance, or removing an instance—invalidates the applicable signed status. Depending on your study’s signature requirements, re-signing may be required to restore the signed status.

Want to see how to perform this task? Watch the video below.

  1. From the Home page, access your study in any given mode. See Access study modes and pages.
  2. Along the top, make sure Subjects is selected.
  3. In the subjects list, locate a subject, and select the checkbox to the left of the subject.

    Tip:

    On the Subjects page, you can use the Review filter to identify subjects and visits that require signing. For more information to filter your list of subjects, see Filter subjects in a study.
  4. Sign data in any of the following ways:
    • Along the top, from the Manage drop-down, select Sign.
    • Expand Signature Request in the sidebar, and for the casebook level signature select Sign.

      The Signature Request sidebar shows all the signature requests that are ready to be applied, according to the signature configurations of your study.

      Note:

      It may take up to 60 minutes for signature request details to become available once subject data has been entered or once signature configurations had been updated.
  5. In the Sign dialog, enter your user name and password that you use to sign in Clinical One Cloud Service.
  6. Select Sign.

If casebook signature is the only signature configuration and is required, signing at the casebook level will make the subject and all their data fully signed. The the Signed icon Signed datadisplays for all signed objects (subject, visit, form, or item). Additionally, you can view the Signed update on the Answer & Visit History sidebar for a form or visit.

If the signature configuration requires form or visit-level signatures in addition to the casebook signature, a form or visit will be in an overall signed status of Partially Signed until all the applicable signature configurations are signed. The partially signed icon (partially signed) display for these.

However, if casebook signature is optional, signing at the casebook level does not change the overall signed status of any object with other applicable signature configurations. Only signing at those applicable levels will make the object become fully signed. And only once all applicable signatures are applied for all subject's data, the subject will become fully signed as well. For more information, see Understand signature configurations.

To sign subject data at the form or visit level, see Sign data at the form or visit level.

Parent topic: Sign data