Sign, verify, and freeze visit dates

Details for sponsor users

As a sponsor user, you can now verify, unverify, freeze, and unfreeze visit dates.

These actions can still be performed even if the study settings prevent the user from entering or editing the visit date.
Targeted SDV toggles are included in the user interface (UI) for the Create Visit dialog and Edit Visit dialog for Source Data Verification (SDV) for Critical Variables (Targeted SDV) and All Subjects.

Note:
These toggles are set to Off by default. These toggles are present for any Scheduled or Unscheduled visit that include a visit date.

More information and step-by-step instructions can be found in the Sponsor and CRO User Guide after the upgrade.

Details for site users

When it comes to your workflow as a site user, you can now sign a visit date at both the subject and visit level. All visit date modifications are reflected in the Answer & Visit History.

In order for the visit date to be eligible for signing at the visit level, at least one question in the study must be entered or updated. This action applies the signature to the visit date associated with the signed visit.

Impact on reports, extracts, archives, or datasets

Report, extract, archive, or dataset	Type of change	Description
Subject Events report	Modified column data	This report now indicates when a visit date is Signed, Verified, or Frozen. The following values have been introduced for the Event Type column when applicable: Visit Date Signed - Subject Level Visit Date Signed - Visit Level Visit Date Unsigned Visit Date Verified Visit Date Unverified Visit Date Frozen Visit Date Unfrozen
Annotated Case report	Modified column data	This report now includes SDV settings for visit dates in the Forms by Visit section.
Study Design report	Modified column data	This report now includes SDV settings for visit dates in the Visit Details section.
Study Design dataset (Events folder)	New column field	The new SDV_VISIT_START column is introduced to this dataset to capture SDV settings for visit dates with the following possible values: NULL ALL SUBJECTS TARGETED SDV
Blinded Subject Event Dataset	New column field	The new SDV_SELECTION_VISIT_DATE element is introduced to this dataset with the following possible values: OBLIGATORY OPTIONAL OPTIONAL_CRITICAL IRRELEVANT This element tracks visit dates for visits associated with the record that's part of the targeted SDV pool for a subject tied to the record.
Unblinded Subject Event dataset	New column field	The new SDV_SELECTION_VISIT_DATE element is introduced to this dataset with the following possible values: OBLIGATORY OPTIONAL OPTIONAL_CRITICAL IRRELEVANT This element tracks visit dates for visits associated with the record that's part of the targeted SDV pool for a subject tied to the record.
Subject Event SVFL dataset	Modified data element	The OBJECT_TYPE element allows you to track visit date actions, such as VERIFY, FREEZE, SIGN, and LOCK.

More information and specific descriptions on modified report values can be found in the Reporting Guide and the Analytics User Guide after the upgrade completes.

Impact on integrations

Integration	Details
Oracle Siebel CTMS Source Data Verification (SDV)	If the visit date is configured as SDV-required, the SDV integration marks the visit as SDV complete in CTMS only after the entire visit—including the visit date—has been verified. If the visit date is not SDV-required, it is ignored when updating the SDV complete status in CTMS. Already using this integration with a live study? For existing integrations, visits previously verified and integrated with CTMS retain their SDV-complete status. Note: No template updates are required to implement this feature.

Integration

Details

Oracle Siebel CTMS Source Data Verification (SDV)

If the visit date is configured as SDV-required, the SDV integration marks the visit as SDV complete in CTMS only after the entire visit—including the visit date—has been verified. If the visit date is not SDV-required, it is ignored when updating the SDV complete status in CTMS.

Already using this integration with a live study?

For existing integrations, visits previously verified and integrated with CTMS retain their SDV-complete status.

Note: No template updates are required to implement this feature.

Already working in a live study?

Once the upgrade completes, visit dates in new and existing studies can be signed, verified, and frozen.

Sponsor users working in an existing study:

If all questions in the visit are frozen at the time of the upgrade, a newly created event moves the visit date to a Frozen status. This allows the visit date to be unfrozen. Furthermore, the entry is logged in the Answer & Visit History and attributed to the system user.
If any questions in the visit are unfrozen or never frozen at the time of the upgrade, the visit date continues to be available for editing and must be frozen by a sponsor user. This results in the visit date no longer being implicitly frozen when the remainder of the questions on the visit are frozen.
If the visit was verified prior to the upgrade, the visit remains verified. However, if another question in the visit requires verification, the visit requires verification whether or not the visit date does.

Site users working in an existing study:

If a visit was signed before the upgrade, the visit is required to be re-signed in order to sign the visit date.
Signature status is not impacted for visits that were signed at the casebook or visit level prior to the upgrade. However, if the visit or casebook is signed after the upgrade, the visit date is also signed.