Review Source Data Verification (SDV) status across subjects and sites in Oracle Clinical One Analytics

You can now generate reports in Oracle Clinical One Analytics to measure and review SDV progress for subjects and sites in a study.

A new data element called SDV_SELECTED_STATUS is introduced in the Subject Form Items dataset. With this, you can now retrieve item-level information about verification requirements, which reflect the SDV configuration applied to a given question. This includes the study SDV settings, the SDV strategy assigned to a given site, and SDV settings defined at the item level in form design.

The SDV_SELECTED_STATUS data element is populated with four possible values. These values indicate if, after all applicable SDV settings combined, the question requires verification or not for the subject.

These values include:

  • OBLIGATORY: indicates the given question is considered required for SDV and must be verified.
  • OPTIONAL: indicates the given question is not considered for SDV for that particular subject. Verification is optional but not required.
  • OPTIONAL_CRITICAL: indicates the given question is set as a critical variable but not considered for SDV for that particular subject. Verification is optional but not required.
  • IRRELEVANT: indicates the given question is not configured for SDV and it is not expected to be verified.
This new data can be used in combination with the previously available data element about item verification (the VERIFIED data element) to track SDV progress. You can use these to identify which items require verification, and out of those which have already been verified or are still pending verification. Some metrics you can obtain from this analysis include:
  • How many form items that require verification are there pending to be verified for a subject?
  • How many form items that require verification are there pending to be verified for a site ?
  • Retrieve a list of all individual form items that require verification for a subject, visit, site, or study.
  • Calculate the completion percentage of overall SDV and targeted (obligatory) SDV, either for the entire study, by subject or by site.

For more information about SDV see Understand Source Data Verification and related topics in the Sponsor and CRO User Guide. You can also find additional information about this new data element in the Analytics User Guide, after the Release Assessment Environment (RAE) upgrade.

Parent topic: Reporting, archives, and analytics