About Source Data Verification statuses

Depending on how your study has defined your Source Data Verification (SDV) settings, you can encounter different statuses and icons in subjects' questions, forms and visits.

For more information about SDV settings and use cases see Understand source data verification.

For studies that use any level of SDV, forms, questions and visits can have SDV related statuses. The following statuses apply:
Status Description
Verification required

The icon for verification required only displays for started visits (never for a question, form or subject) when at least one of its question has never been verified and requires verification, and as long as there is no data in the visit that is unverified.

Note: If a started visit is cleared, it returns to a state of new, so the icon for verification required disappears.
Verified The item has been verified by the user. You can verify a question, form or visit directly.

A form, visit or subject becomes verified when all its questions that require verification are verified and as long there is no data that is unverified.

Note: When you verify a form or visit directly, only the questions that are visible to the user will be verified. Hidden questions will not be verified. If any hidden question requires verification, the form or visit will not become verified until that hidden question is also verified.
Unverified A question was once verified but then updated, so it becomes unverified.

A form, visit or subject becomes unverified if at least one of its questions that require verification is unverified.
Each status is identifiable by their respective icons. Visits that do not require SDV are identifiable by the absence of any SDV-related icons. For more information see What does each icon mean for signing, verifying, or freezing data?

Changes to the SDV status

During the study conduct period, forms, questions, and visits can change status as a result of certain actions. Records for these actions and changes of status are listed in the Answer & Visit History, attributed to the user who performed the verification action. Even visits that do not require SDV can acquire an SDV status and display the given icon.

Once any of the following actions occur, the status is updated as applicable:

Note:

Whenever there is a change that indirectly impacts the SDV status (changes other than data update or user manually performing SDV), the system recalculates the SDV status and updates it when applicable. When this happens, the record for the change of status is also listed in the Answer & Visit History and it is attributted to AutoSDV.

The changes that can trigger SDV status system reclaculation (AutoSDV) include changes applied with Advanced Study Versioning (ASV), dynamic questions or forms being shown or hidden, selection of a subject for the SDV pool, and changes to the SDV Strategy assigned to a site.

  • A question becomes Verified after a Clinical Research Associate (CRA) user verifies it.
  • Forms, visits and subjects become Verified when all their questions that require SDV get verified, as long as there is no unverified data. If there is at least one question in unverified status, the whole form, visit and subject get an Unverified status.
    • Visits that don't require verification become Verified with just one question being verified, regardless of any unverified data.
    • Hidden questions with data classifications may also require verification. For users that are not allowed to view classified data, it may happen that a form or visit has a Verification Required or Unverified status even when they see all data within as verified. This would indicate that the data that is pending verification is classified and another user with the appropriate permissions must do it.
  • A question becomes Unverified if it gets updated after being verified.
  • A form or visit can become Verification required if a new question requiring verification is added to the visit, after the visit has been verified. This may happen when the following occur:
    • A completely new question is added to the form by the study designer and it is SDV required.
    • An existing question is updated to become SDV required.
    • A parent question is updated and the new answer triggers the display of a dynamic question that is SDV required, or a dynamic form with at least one question that requires verification.
  • If you update the Include Screen Failures setting from Yes to No, screen failed subjects get excluded from the SDV subject pool and SDV is no longer required for them. Any data that was previously verified for screen failed subjects remains Verified, but any subsequent data changes will not impact the SDV status of the subject.

    Note:

    Questions marked as SDV for All Subjects remain SDV required for screen failed subjects, even when excluded.
  • A subject's visits can become Verification required if the given subject is selected for the targeted SDV subject pool (Targeted SDV only). This can happen even after the visit has been verified or for visits that didn't have any SDV-required questions.

    Note:

    Changes to the SDV settings and SDV strategy can impact the number of subjects requiring SDV and how they are selected. For more information, see How are subjects selected for targeted source data verification?
  • The number of questions requiring SDV may decrease due to changes in the SDV settings This can change the status of a visit from Verification Required to Verified.

    For other details on how your study is impacted when SDV settings change, see How do changes in Source Data Verification settings impact a study?

Related Topics

Parent topic: Monitor subjects and sites