Webinar Recording

This video is a recording of the Viedoc SDV Manager webinar, part of the "Working Smarter series":

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Note! After discussion with Antti 18/3 add ROW link "here"..not China link.

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SDV Manager - Q&A

Enabling SDV Manager

Q: Would this be available for running studies, or only for new studies?
A: Viedoc SDV Manager can be enabled in ongoing studies. Please be aware that enabling Viedoc SDV Manager for an ongoing study cannot be undone.

Q: If SDV Manager is activated for an ongoing study, will we have to create a new design version to update the roles correspondingly?
A: If you enable Viedoc SDV Manager for an ongoing study, you will need to update your design to add new role permissions to the relevant roles (through a new design version or a revision). The SDV requirements will be removed when switching to SDV Manager, and new requirements will need to be set up in SDV Manager by configuring and assigning SDV plans. Any SDV already performed before the switch will be retained.

Please be aware that enabling Viedoc SDV Manager for an ongoing study cannot be undone.

Q: Can we use SDV Manager on one of the training environments (for testing purposes) without a license key?
A: Yes, Viedoc SDV Manager can be tested on the training environment without a license key.

SDV Plans

Q: Is it also possible to define SDV for critical data only?
A: Yes, when you define your SDV plans, you can target specific items. First, you define rules in your plan. The rules will allow you to target certain subject statuses, as defined in Viedoc Designer. This will allow you to e.g. have one rule for screening failures, and another rule for the remaining subjects.

In each rule you can define multiple targets, where you define SDV requirements for any item in any form and whether it should be treated differently in different events and activities. Each target will also specify whether the selected items should require SDV, be optional to SDV, or not allow SDV at all. Finally, for forms and events using repeat keys, you can define that only certain repeats should be applied for that target, for example, requiring that the first two records of the medical history log should be SDV:ed.

Q: Is it possible to set a rule that targets, for example, "only the first 2 subjects of a site?"
A: No, this is not possible. The intention behind targeting early subjects is often to catch quality concerns early, so that appropriate actions can be taken quickly. Viedoc addresses this by assigning an SDV plan for the first time period. This allows you to assess site quality quickly. Once quality is deemed sufficient, the SDV plan can be updated to reduce verification effort across all patients. This avoids spending time on SDV for early subjects throughout the study, even when you already know the site is performing well. This is especially efficient when subjects are included in a study for a long time.

Consider a subject being enrolled for 24 months, with a monthly visit. If you can determine within two months that the quality is high, you can assign a plan with reduced SDV to the site, so that you can avoid spending time on SDV on a site that you already know is performing well.

If the recruitment pattern is different, and more aggressive, for example a new site is planning to perform many screening visits, visit 2 and visit 3 visits during the first two months of a study, we recommend planning for assessing the site quality as early as possible to be able to reduce SDV levels across all subjects.

Q: Can we base the rules on other items than Viedoc subject status?
A: Currently this is not possible. However, since "screening failure" is now available as a subject status in Designer, this status can be used as a rule condition.

Q: When updating the SDV Plan, is the previous version saved? Can a previous version be restored?
A: If you update a published SDV plan, you can discard all unsaved changes. However, once a plan has been published, earlier versions cannot be restored. There is an audit trail detailing the content of previous versions, and you can manually recreate an earlier version if needed.

Q: Can a specific SDV plan be assigned to subjects only, not just to sites?
A: SDV plans are assigned to one or multiple sites by event date, not to specific patients. This approach matches verification effort with risk periods at a site, since risk is rarely tied to a specific participant. However, if there is a strong rationale for performing additional verification on a specific participant, optional SDV can be used to document this in the system. This should be treated as an exception rather than a routine procedure.

Q: Does Viedoc allow for an approval process for SDV plan updates/changes (e.g. via a 'sponsor' role)?
A: Yes, this is possible through role permissions. Giving one role permission to create/edit a plan and another role the permission to publish a plan will create an approval process for SDV plans.

Q: Is it possible to configure SDV on an individual item basis even when some items are hidden?
A: Enabling SDV Manager enforces the use of item-level SDV. This means form-level-only SDV is no longer possible for new studies: SDV can still be performed on form level, but it will also always be possible to perform SDV on item level. Please be aware that hidden forms, hidden items, functions and static texts can't be included in an SDV plan. These elements are not available when configuring your SDV plan.

SDV Plan Assignment

Q: If the plan is changed from a specific date onwards, does that mean that all data newly entered after that date will follow the new SDV requirements? Or does it also affect data that was modified after that date?
A: The new plan will apply to all data with an event date on or after the effective date of the assignment.

Q: What does the system use to determine which SDV plan is applied to an event/form/item? Is the Event Date used for the whole visit? What variable is used for log-section entries like AEs?
A: Yes, the EventDate determines which SDV plan applies to each event. The EventDate is also used for common events even though it is not visible inside the Viedoc Clinic UI. An "automatic event date" is always used for a common event. For such a date you can choose between different settings: "First data entry" (meaning that the date of data entry will be used as the EventDate) or "Form item" (meaning that you can select a date item in the form, and this will be used as the EventDate).

When using Viedoc SDV Manager, we recommend not using "form item" and selecting a date that could be a historical date, such as "medical history start date". This would risk having an event date before the date when the first SDV plan is assigned. In such a scenario, the event would never require SDV. First data entry is often the better option when automatic event date is used.

Q: When setting an active (past) date for SDV plans, will they just include items in forms that were changed after this date?
A: No, when assigning an SDV plan by using a past date as the effective date, all items in all events on or after that date will use the newly assigned plan. The purpose is to upgrade or downgrade SDV for all data in that time period.

Q: Can you add the reason why the SDV plan is changed for a site, for tracking purposes?
A: This will be added in the upcoming release, Viedoc 4.96.

Audit Trail

Q: Are there any audit trails on the SDV plans?
A: Yes, there is an audit trail for SDV plans and SDV plan assignments. A summary is displayed on the screen, and the full details can be exported in CSV format.

Performing SDV in Clinic

Q: Is it possible to SDV non-required items in the data review console?
A: The data review console will continue to work as it does today: you can perform form-level SDV directly from it. Checking form-level SDV will mark all required items as SDV:ed, but will not affect items where SDV is optional. If you open the form, you can also verify individual items. With the form open, you also have the option to check form-level SDV directly, which has the same effect.

Q: Is there an SDV flag for indicating: "I performed SDV but identified a transcription error"?
A: No, this is not currently possible, but is an interesting idea for future consideration.

Q: If you are using optional SDV in a form and it was left blank, will it show as 100% SDV in reports?
A: Yes, optional items that have not been SDV:ed are not counted in the SDV metrics, so leaving them blank will still show 100% where all required items are complete. Optional SDV that has been performed can still be tracked in the exports.

Q: Every time a change is made in the eCRF to an item on which we have already performed SDV, will it be marked as not done?
A: Yes, any data edit will remove the SDV performed status.

Q: Is it now possible for all roles to view the item-level SDV status within each form?
A: No, the introduction of Viedoc SDV Manager does not change the current behavior in this regard.

Metrics, Exports and Reports

Q: What about the SDV percentage on the landing page — will it be removed? Is optional target SDV considered in the percentage of total SDV percentage?
A: There is no current plan to remove the SDV percentage on the landing page. The percentage of completed SDV is calculated by taking the performed SDV on forms requiring SDV divided by forms requiring SDV.

Q: Will you be able to see the SDV status of the sites in Viedoc Reports?
A: Some information will be visible in Viedoc Reports. Viedoc Reports will continue to show whether a form requires SDV (meaning that at least one item in the form requires SDV) and whether SDV has been performed on a form (meaning all required items in the form are SDV:ed). It will currently not be possible to see details about the SDV plans, metrics for items optional to SDV, or SDV on item level.

Q: Is 'SDV requirement' information (available in export) also available in Viedoc Reports tables, to be used for custom reports?
A: No, the SDV dataset is not currently available in Viedoc Reports.