Include or exclude screen failed subjects from Source Data Verification
Sponsor users can now have more control over a study's Source Data Verification (SDV) definition and decide whether to include or exclude screen failed subjects from the pool of subjects that require data verification.
Note:
This new enhancement doesn't impact your study's integrations, JavaScript custom rules, standard reports in Oracle Clinical One Platform, data extracts or archives. While it doesn't introduce any workflow changes in Oracle Clinical One Analytics, consider that this setting may impact SDV requirements for a question and subject, and that this data will be refreshed in Oracle Clinical One Analytics datasets to reflect the latest updates.Before you work with this feature
No new permission is introduced with this enhancement. To include or exclude screen failed subjects from your SDV strategy, you only need to be assigned the existing permission Create and Manage SDV Strategies.
Details for study managers or other sponsor users
If you're a study manager or other sponsor user who's in charge of managing SDV in a study, with the Include Screen Failure setting you can now control whether to include or exclude screen failed subjects.
This setting is available for studies that use any type of SDV, full or targeted. However, it is particularly useful for targeted SDV studies. This is because targeted SDV studies require data verification only for a randomly selected subset of subjects, and there is typically just a small amount of data collected for screen failed subjects. If a screen failed subject is selected, they take the place of an enrolled subject who could have otherwise been chosen for the SDV pool. With this setting, you can ensure that only enrolled subjects are selected for data verification, as they generally provide more data that might provide more relevant insights for your study's analysis.
- When the Include Screen Failures setting is set to
Yes, the SDV subject pool considers subjects for data
verification as soon as they have been added to the site.
Given that screen failed subjects are eligible for SDV, the total count of subjects considers screen failed subjects. This total count of subjects is used to calculate the percentage of remaining subjects to be selected (targeted SDV only).
- When the Include Screen Failures setting is set to
No, the SDV subject pool doesn't consider subjects for data
verification until their status is Enrolled or Randomized.
When considering the initial subjects selection, subjects are evaluated in
the order that they are added to a site and a subject is not skipped for
data verification unless it gets a status of Screen Failed. Even if a
subject added later is enrolled first.
Given that screen failed subjects are not eligible for SDV, newly added subjects, screen failed subjects, and subjects whose screening is in progress are excluded from the total count of subjects, which is used to calculate the percentage of remaining subjects to be selected. These subjects can only be later included in the total count if they become eligible for SDV, and this may happen if they get later successfully screened or become completed.
Note:
For targeted SDV, questions that are marked as SDV for All Subjects still require verification for screen failed subjects, even if excluded from SDV. Questions marked as Critical Variables and other questions with no SDV configuration do not require verification for excluded subjects.
Details for Clinical Research Associates (CRAs)
While nothing has changed in your application's workflow, know that you may be able to verify data of subjects whose status is Screen Failed in the application. This all depends on whether your study's SDV settings allows that or not.
Already working in a live study?
If you are already working in a live study, updating this setting may impact the subject selection for SDV:- If you update the Include Screen Failures setting from
Yes to No after adding subjects in a specific study mode
(Testing or Production), any screen failed subjects previously selected for the
Initial Subjects or Remaining Subjects pools get excluded and
no longer require data verification.
A new subject is to be selected only if the site's current strategy requires replacement. For example, if you had selected three initial subjects and one of them was a screen failure and gets deselected, a new subject will be selected to meet the initial subjects count. But, if you also changed the strategy to two initial subjects, no new subject would be selected since two initial subjects would remain.
- When you update the Include Screen Failures setting from Yes to No, and excluded screen failed subjects no longer require SDV, any data that was previously verified remains verified. Any subsequent data changes will not impact the SDV status of the subject.
- If you update the Include Screen Failures setting from No to Yes, no changes occur for existing screen failed subjects, although they become eligible for SDV moving forward, based on your existing SDV strategy's algorithm.
- If a screen failed subject gets withdrawn or completed, it is no
longer considered as screen failed but as either withdrawn or completed.
Completed subjects are eligible for selection of the SDV subject pool, but
withdrawn subjects are not.
Note:
These scenarios are only possible if the Screen Failed Subjects setting in the study settings is set to Allow Withdrawal or Allow Completion respectively. - If you change the Include Screen Failures setting from Yes to No or viceversa, any SDV-related information existing in Oracle Clinical One Analytics datasets is updated to reflect the changes to the SDV selection status (SDV_SELECTED_STATUS) for an item and subject.
For more information about SDV, SDV strategies and subject selection see Understand Source Data Verification and related topics in the Sponsor and CRO User Guide. You can also find additional information about this new functionality, after the Release Assessment Environment (RAE) upgrade.
Parent topic: Data review