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 questions has never been verified and requires verification. 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 of its questions that require verification are verified and as long there is no data that is unverified. 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. If within a visit or form with the status of Verified a verified question or form is unverified, then the entire visit reverts to the status of Verification Required.
Unverified	A question was once verified but then updated, so it becomes unverified. Data can be unverified by a CRA, but it can also be unverified as part of a change in data, such as a site user updating specific visit data. A form, visit or subject becomes unverified if at least one of its questions that require verification is unverified.

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 questions has never been verified and requires verification.

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 of its questions that require verification are verified and as long there is no data that is unverified.

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.
If within a visit or form with the status of Verified a verified question or form is unverified, then the entire visit reverts to the status of Verification Required.

Unverified

A question was once verified but then updated, so it becomes unverified.

Data can be unverified by a CRA, but it can also be unverified as part of a change in data, such as a site user updating specific visit data.

A form, visit or subject becomes unverified if at least one of its questions that require verification is unverified.

For more information about the icons associated with SDV statuses, 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:

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 with an unverified status, the whole form, visit and subject receive the status of Verification Required.
- 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 the status of Verification Required 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 is no longer Verified if it gets updated after being verified.
A CRA manually unverifies a question, causing a question to receive the status of Unverified.
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. This can only happen in the following scenarios:
  - The subject is selected for the SDV pool.
  - The site's SDV strategy changes.
- 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?
If a user manually unverifies a question that is part of a visit with the status of Verified, then, depending on if the question requires SDV, the visit reverts to the status of Verification Required.
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?

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 attributed to AutoSDV.

The changes that can trigger SDV status system recalculation (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.

Related Topics

Parent topic: Sign, verify, freeze, and lock data