What changes can I implement using Advanced Study Versioning (ASV)?

To make any of the changes listed below, you first need to Create a new Draft study version. For additional information, see Add or update a question in a live study version.

Update code lists with ASV

When you update code lists using ASV, it's important to understand how these changes are applied.

Code lists in a live study can be updated to add new options or adjust existing ones. However, some changes to code lists don't affect previously collected data. Site users need to interact with the question for some of those changes to be applied to subject data. No updates will be applied automatically to existing data.

After updating the code list, open the form (in Draft mode) and go to the applicable question. Then, select the Code List button and choose the updated code list to apply the updates you previously made. Lastly, apply this change as an Advanced Study Versioning (ASV) change. For more information on how to apply ASV changes, see Add or update a question in a live study version.

For more information about code lists, see About managing code lists and Manage a code list for all or one study.

WARNING:

Consider the following rules before updating a code list:

In general, ASV changes are applied at the User Interface (UI) level. This means users will see the updated code list options in forms going forward. Any data that was entered before the ASV change will not be automatically updated. The original code list used at the time of data entry remains "locked" with that question and data.*
You can add, re-order, or hide code list options at any time, but these changes do not apply to existing collected data.
If you update a code list, the changes don't automatically apply to existing questions - you must reapply the updated code list to the question in the Draft (study design) version for the updates to take effect. Updating a code list doesn't change previously collected data. To apply the new or updated values, site users must revisit the form and re-select the answers after the updated study version is in place.

Change	Allowed with ASV	Impact on existing data	Additional information
Add new options	Yes	New code list options will be available for selection going forward. Answers already collected remain unchanged. No existing subjects' data is modified.	Applies to all relevant questions.
Update label of existing option	Partially	New label appears in all applicable forms going forward, but historical answers still display the original label in reports, extracts, and the Answer & Visit History sidebar. Stored data is not overwritten.	To see the updated label for existing answers, a site user must return to the form, re-select the value with the updated label from the code list, provide a reason for change, and save the updates in the form.
Update code value of existing option	Partially	New code value appears in all applicable forms going forward, but historical answers still display the original code value in reports, extracts, and the Answer & Visit History sidebar. Stored data is not overwritten.	To see the updated code value for existing answers, a site user must return to the form, re-select the value with the updated code value, provide a reason for change, and save the updates in the form.
Re-order options	Yes	The order change is displayed in all forms for all subjects, including for questions with already collected data. Stored data is unaffected.	This change can be applied at any time during the study conduct period.
Hide options	Yes	The code list option no longer appears for data entry in all forms. Selections made before the change remain stored in the database, reports, and extracts.	If the site user changes the value, they will not be able to select the previously chosen, now removed, option again.
Assign a different code list to a question	No	You cannot assign a different code list to a question, if that question is included in an approved study version.	None.

Apply other changes to a live study version using ASV

Note:

Consider the following notes:

Moving a study version that includes an ASV change to Testing or Approved triggers an asynchronous job that recalculates the status of visits in that study mode affected by the change. For more information, see About the Advanced Study Versioning (ASV) asynchronous job.
To create a new Draft study version and add a new question, see Update a form in a live study version.
Converting an existing question to required or adding new required questions reverts the form status to Incomplete for visits that were already completed. The form status changes to Incomplete only if the question was not previously answered.

Change	Additional information
Add a new form to a visit.	The Apply Changes to Study Version drop-down works at the question level. To add a new form in a live study version using ASV, you must select the applicable study version for all questions on the new form. For more information, see Add a new form to a live study version.
Add a new question to a form.	For more information about the different questions you can create, see Question types and settings. If the new question you're adding is required, make sure you turn on the Required for toggle on the Details sidebar.
Convert an existing question to required.	Turn on the Required for toggle on the Details sidebar to convert an existing question to required.
Reorder questions in a form.	To reorder questions on a form, open the form and drag each question to its new position.
Modify non-label questions on a tabular form (repeating form, lab form, two-section form).	You can apply question-level ASV changes to any question in a tabular form except label questions. For example, you can update the Lab Result text question but not the Lab Test label question. In repeating or two-sections forms (including lab forms), the selected study version in the Apply Changes to Study Version drop-down, applies to all non-label questions. If you apply ASV changes to the Lab Result text question, all other non-label questions in the form inherit that study version. To revert this change, you must remove the study version from all questions; otherwise, the ASV tag will reapply. For more information about label questions, see Create a label (repeating table only). For more information about tabular forms, see Create a form with two sections, Create lab forms, or Create a repeating form.
Change a question's label to correct spelling errors.	To update a question's label, open the form, select the question, and edit the label. For example, change Weight to What is the subject's weight?. A question label is the text shown as the question itself, while a label question is a table heading used in tabular forms (repeating, lab, or two-section forms).
Change the number format for a question.	To change the number format, select the question, and then choose a value from the Format setting on the Details sidebar. For more information, see Create a number question.
Modify or add a unit of measure to a number or age question.	Note: Updating a unit of measure with ASV changes the unit in the UI for all applicable questions, even those with existing data. However, previously collected values remain stored with the original unit and continue to display in reports and extracts. For example, if you change a weight question from kilograms (kg) to pounds (lbs), the form shows pounds, but existing values in kilograms remain unless the site user clears and re-enters them in pounds. To modify or add a unit of measure to a number or age question, select the question, choose Include Unit of Measure, and then enter the applicable value. For more information, see Create a number question and Create an age question.
Update the character limit of a text question.	To update the character limit of a text question, select the question, then use the arrows next to the Character Limit setting on the Details sidebar to increase or decrease the number of characters a user is allowed to enter when answering the question. For more information, see Create a text question.
Update a Date/Time question to allow partial dates or update the minimum answer required.	The Minimum Answer setting is only available when Partial Date Allowed is enabled. To update the Partial Date Allowed and Minimum Answer settings for a date/time question, select the question, then make the updates in the Details sidebar. For more information, see Create a date/time question. Note: You are permitted to make a change to collect less information, but you cannot apply an update that requires the collection of new information. For instance, if the Minimum Answer setting is MON-YYYY, you can only change it to YYYY; changing it to DD-MON-YYYY is not allowed.
Change the Advanced Properties for a question.	Select a question, then expand the Advanced sidebar to view the advanced settings associated with it. Changes to the SAS Variable and SAS Label are applied to all data, since SAS datasets are aggregate representations of all data collected for the form and question. The Rollover Question property can also be configured as an ASV update. The Coding Question property and the Subject Tag cannot be updated using ASV. For more information about the different question types and their advanced properties, see Question types and settings.
Add or update a predefined validation rule for a question.	You can change the rule criteria or adjust toggles to make a rule act as a simple validation, a query, or validation with a query. For more information, see About validation rules. After ASV changes are applied, an asynchronous job re-evaluates all validation rules: validations are applied or resolved, and queries are opened or closed as needed. While the job runs, you may encounter a delay before the updated logic appears on existing data. For more information, see About the Advanced Study Versioning (ASV) asynchronous job. Note: Manually closed queries are not re-evaluated unless the data changes, even after an ASV update to the rule is applied.
Add or modify a dynamic visit in the schedule of a live study by creating a Show Visit rule.	For more information, see Add a dynamic visit in the schedule of a live study. You can also review Set up a dynamic visit to see additional information about dynamic visits.
Add or modify Show Question or Show Form rules.	For more information, see Set up a dynamic question in a form and Set up a dynamic form.
Update a question's hidden status and add, modify, or remove data classifications.	For more information on how to perform this task, see Define data classifications for a hidden question. Also, consider the following use cases: 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 is shown 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 is then hidden using ASV, the question is hidden in the table view but it is visible if the repeating form or when the repeating section row is opened in a new dialog. If you hide a question, make sure to verify its required status. A hidden question that remains required is still taken into account when the system calculates the completeness of the form and visit.

Changes you can apply to a live study version but cannot apply using ASV

You can make the changes listed below in a live study version, but you cannot apply them using ASV. The system lets you make a selection from the Apply Changes to Study Version drop-down, but the updates are only applied to new (not-yet-started) visits and not those that have already begun.

Note:

When ASV is not used, the updated Draft study version must be approved and manually assigned to the impacted sites in the appropriate modes.

Change	Additional information
Add or change Link & Show Form rules.	Link & Show Form rules are only available for questions with radio buttons. For more information, see Create a question with check boxes or radio buttons. Additionally, you can review Set up form associations and Define a Link & Show Form rule.
Update Source Data Verification settings for a question.	For more information on how to make such updates, see Configure source data verification settings for a question.
Update Alert if Outside the Visit Window configuration in the visit schedule.	For more information, see Define the visit schedule. For more information on how to insert a visit into the schedule of a live study, see Set up a visit that must be inserted into the schedule of a live study version.
Add new Oracle Central Coding target questions.	You can add new coding targets through as an ASV update, but this affects your study and its medical coding data. New coding targets are visible on forms for all subjects, even if the visit containing the coding forms (typically the Logs visit) hasn't started. However, for visits started before the study version was updated, the new targets cannot be populated - they only apply to visits started after the ASV update is made. This is because the code map, which includes the mappings defined for the Oracle Clinical One Platform form questions and the relevant Oracle Central Coding dictionary levels, is locked once the visit begins. For more information, see Create the coding target fields.

Changes you cannot apply to a live study version

The following study design changes aren't allowed, as they may impact data integrity.

Change	Additional information
Delete a form in a visit that is used in an approved study version	Deleting a form that is used in an approved study version is allowed but doing so could disrupt your data collection processes or cause errors in your study's design.
Delete or update a question that is used in an approved study version.	The system blocks you from deleting a question or updating its question type once it has been used in an approved study version. Note: If you need to remove a question, hide it instead of deleting it. But before hiding, determine whether the hidden question should be required or optional. A hidden required question still counts as required, which can prevent users from completing the form.
Some changes to date/time questions	You are prohibited from updating the Type, Format, and Partial Date Allowed settings for a date/time question that is already used in an approved study version. You can change the Minimum Answer setting, but you can only select options that include all or some of the elements that were previously selected. For instance, if the Minimum Answer setting is MON-YYYY, you can only change it to YYYY; changing it to DD-MON-YYYY is not allowed. See asv-changes.html#GUID-3C4A0899-DF3C-4A34-A2DB-23CEA5CCA8D2__GUID-F2EE3C1A-15B8-4AC8-962D-B128B104BA98, row Update a Date/Time question to allow partial dates or update the minimum answer required.
Remove or make changes to label questions in a repeating form.	Doing this would affect any tabular forms included in your study, as well as lab forms.