About Advanced Study Versioning (ASV)

You can update a form retrospectively in a live study with Advanced Study Versioning (ASV), without going through the entire versioning process. However, there are some form updates that are not allowed after the study is approved.

To update a form using ASV, as you edit a question in a form in Draft mode, you must select a study version to apply your changes to. Locate the Apply Changes to Study Version field in the Details section on the sidebar, and select a study version from the drop-down.

By selecting an older version, your changes will apply to that selected version and the subsequent ones. However, for your changes to become effective on the applicable study versions, the new study version (in which you made the changes) must follow the normal versioning process. This means that, as soon as the new study version reaches the Testing container, changes will go live in Testing mode for all applicable study versions and apply to all testing sites to which those study versions are assigned. Similarly, as the new study version reaches the Approved container, changes will go live in Production mode for the applicable study versions and apply to all sites assigned with the given study versions.

Updating a form through ASV means changes apply to all subjects, including past visits in which site users have already started or completed the given form. This means, in case of a new or modified question, the form becomes incomplete and the question will be unanswered.

Tip:

To make sure all missing data gets collected, we recommend that you create a rule that opens a query when incomplete data is detected in a form. For step-by-step instructions, see Create a rule for an automated query. You may also refer to Item completion check for rule examples with this purpose.

Changes I can apply to a live study with ASV

Here are some cases when you can apply ASV changes, without having to change the study version for every site that is impacted by the change:

• Add a new question to a form.
• Reorder questions in a form.
• Change a question label to correct spelling errors.
• Update a question to be or not to be hidden, with or without data classifications.

  Note:

  • If a locked form or question group is completely hidden using ASV (all questions are locked and then hidden), with or without data classification applied, the form will show as the last form in the visit.
  • If a question in a repeating form or a two-section form is locked, while other questions are not, and then is hidden using ASV, the question will be hidden in the table view but will be visible if the repeating form or repeating section row is opened in pop-up view.
• Change the Advanced Properties for a question.
• Update the character limit for an item.
• Change the number format for a question.
• Update a Date/Time question to allow partial dates or update the minimum answer to remove required components.
• Modify or add a unit of measure to a question.
• Change Show Question/Show Form rules.
• Add a new form to a visit.

  Note:

  The Apply Change to Version setting works at the question level. To add a new form in a live study version with ASV you need to select that live study version for each question in the new form. See Add a new form to a live study version.
• Add a dynamic visit in the schedule of a live study by creating a Show Visit rule.

Refer to Update forms and visit schedule during the study conduct period for step-by step instructions on the different changes you can make using ASV.

Changes I can apply to a live study, but not possible with ASV

The following changes can be made, but won't be applied to a live study version even if the question is selected for ASV:

• Add or change Link & Show Form rules.
• Update Source Data Verification settings for a question.
• Update Alert if Outside the Visit Window configuration in the visit schedule.

If you need to apply these changes, the updated draft study version must be approved and assigned to the impacted sites in the appropriate modes.

Changes that are not allowed in a live study

• Remove a question or a form that is used in an Approved version of the study.
• Change the type of a question.
• Update a multiple-choice question (drop-down, checkboxes or radio buttons):
  • Add answer options or code list values.
  • Remove answer options or code list values.
  • Change labels of multiple-choice answers.
  • Re-order code list items.
  • Remove a code list or select a new one.

  Note:

  A code list may be modified from the Code List tab at either Study or Global settings level. However, these changes won't impact a question currently using that code list and the question answer options will remain unchanged.
• Change the date format and type in a Date/Time question.
• Update a Date/Time question to not allow partial dates or change the minimum answer to include components that were previously allowed to be unknown.
• Remove or make changes to label items in a repeating form.

  WARNING:

  This would affect any tabular forms included in your study, as well as lab forms.