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 that specific study version. 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 you can apply to a live study with ASV

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.

All the changes allowed with ASV can also be applied through the usual study versioning process. However, using ASV can reduce time an efforts to apply them. 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:

Change	Additional information
Add a new question to a form.	See Update a form during the study conduct period. For more information on the different questions you can create, see Question types and settings.
Reorder questions in a form.	See Update a form during the study conduct period. To reorder questions in a form, open the form to edit it, and drag and drop each question to its new position.
Modify non-label questions in a tabular form (repeating form, lab form, two-section form).	See Update a form during the study conduct period. 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.	See Update a form during the study conduct period. When updating a form, select a question to update its label.
Add a new code list value or answer option for a choice-type question (Not applicable for Label items).	The new values are added at the bottom of the code list. For more information, see Manage a code list for all or one study.
Change the number format for a question.	For more information, see Create a number question.
Modify or add a unit of measure to a question.	This only applies to number and age questions. See Create a number question or Create an age question.
Update the character limit for an item.	This only applies to text questions. See Create a text question.
Update a Date/Time question to allow partial dates or update the minimum answer to remove required components.	For more information, see Create a date/time question.
Change the Advanced Properties for a question.	For more information on the different questiontypes and details about their advanced properties, see Question types and settings.
Add a dynamic visit in the schedule of a live study by creating a Show Visit rule.	See Add a dynamic visit in the schedule of a live study. For more information about dynamic visits, see Set up a dynamic visit.
Change Show Question or Show Form rules.	For more information about the Show Question rule, see Set up a dynamic question in a form. For more information about the Show Form rule, see Set up a dynamic form.
Add a new form to a visit.	The Apply Change to Version setting works at the question level. For this reason, to add a new form in a live study version with ASV, you need to select that live study version for all questions in the new form. See Add a new form to a live study version.
Update a question to indicate whether it should be hidden or not and to specify or remove any 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 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 when the repeating section row is opened in a new dialog.

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

You can make any of these changes in your study's design, but even if you select them for ASV, they won't be applied. Instead, you should go through the usual process for updating a study design change where you create a new study version and take it through Testing and Approved.

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.

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

Change	Additional information
Add or change Link & Show Form rules.	For more information, see Set up form associations.
Update Source Data Verification settings for a question.	For more information on how to perform this task, 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
Add new Oracle Central Coding target questions.	You can add new coding target questions using ASV and it would result in the new fields appearing on the forms for all existing and new subjects in Oracle Clinical One Platform. However, for existing subjects for which the given visit was initiated (before the new coding targets were added), the new fields for coded verbatim terms are not populated in Oracle Central Coding. This is because the code map, comprised of the mappings between form questions and the applicable dictionary level, is established and locked for a subject when the visit is initiated. For more information, see Create the coding target fields.

Changes you cannot perform in a live study

Some study design updates may impact your data's accuracy and integrity, so they are not allowed in the application's User Interface (UI). The following study design changes aren't allowed in your study's design:

Change	Additional information
Remove a question or a form that is used in an Approved version of the study.	Deleting a question or form that is used in an Approved version of a study could disrupt your data collection processes or cause errors in your study's design.
Change a question's type.	For example, modify a Text question to turn it into a Date/Time question.
Some changes to date/time questions: Change the date format. Change the type (Date & Time, Date only, or Time only). Update a date/time question that allows partial dates to not allow partial dates. Update the minimum answer to include components that were previously allowed to be unknown.	These types of changes might cause some previously entered dates to become incomplete or invalid. If you try to update a date/time question that is already used in an Approved version of the study, you would see most of these settings are read-only and cannot be changed. You do have the option to change the minimum answer, but you only see options that include all or some of the elements that are already part of the minimum answer currently selected.
Remove or make changes to label items in a repeating form.	This would affect any tabular forms included in your study, as well as lab forms.
Change choice-type questions (drop-down, checkboxes, or radio buttons): Change a choice-type question's label. Remove a code list or select a new one for a choice-type question. Remove or re-order answer options or code list values for choice-type questions.	A code list may be modified from the Code List tab at a study level or on the Global Settings page, at a global level. However, these changes won't impact a question currently using that code list and the question answer options will remain unchanged in study design. This is because the applied code list is directly associated to the question and stored with the question. If you make a change to a code list that was already applied to a question in a form, you need to re-add the code list to that question in order to see its changes reflected in the form. However, this workaround is not possible if the question is used in an Approved version of the study.

Parent topic: Updates during the study conduct period