Sign data at the form or visit level

If your study requires you to sign data for visits or forms then you must perform this task to ensure that the data is accurate.

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:

If changes are made to signed data, the data becomes unsigned and requires re-signing. This also applies if a site user removes a completed and signed repeating form instance, as the visit (and subject) to which the form is associated with becomes unsigned.

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, and that you're on the Subject Overview view.
3. In the subjects list, locate the subject to sign data for.

   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. Open the visit that requires your signature or that contains the form that you must sign. Do one of the following:
   • If you know the visit, open it directly from the Previous Visits column.
   • Expand Signature Request in the sidebar, and for the given visit or form 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. On the Signature Request sidebar, click Select for the visit or form that requires your signature. You can select multiple signature requests.
6. Select either Sign or Sign & Close.
7. In the Sign Data dialog, read the affidavit.
8. Acknowledge the affidavit by entering your Username and Password, then select Sign.

The the Signed icon displays for all signed objects (subject, visit, form, or item). Additionally, you can view the Signed update on the Answer & Visit History sidebar.

A form or visit will be in an overall signed status of Partially Signed until all the applicable signature configurations are signed, including any configured form and visit level signatures, and the subject's casebook signature when required. The partially signed icon () display for these.

However, casebook signature can be optional and, if that is the case, signing at the form and visit level is enough to make the form or visit become signed. Once all applicable signatures are applied for a subject's data, the subject will become fully signed as well. For more information, see Understand signature configurations.

To sign a subject's entire casebook, see Sign data at the casebook level.