Add or update a question in a live study version

Apply updates to your questions using Advanced Study Versioning (ASV) to control the version of the study associated with each change.

Before you make any changes to your live study using ASV, consult the list of changes that can and cannot be applied through ASV. See What changes can I implement using Advanced Study Versioning (ASV)?.

Note:

Consider the following:

• When you apply ASV to a question in a repeating form with label questions or a two-section form with or without label questions (including lab forms), keep in mind that the study version you select is applied to all non-label questions on the form. To revert the ASV change you made for the Lab Result text question, you must remove the selected study version from the Apply Changes to Study Version drop-down for all questions on the form. Otherwise, the ASV tag will be re-applied to any question where it was only removed individually.
• If the form you updated was already completed by any of the subjects during the study, the site users must return to that form and answer the questions that you added or modified.
• When an existing static question, form, or visit that includes data, is changed to a dynamic type, and the determining question is set to be hidden, the new dynamic question will be hidden. If the determining question is updated to the criteria to show the dynamic question, that question appears and the original data is still there.

1. First, do one of the following:
   • If you work in an existing study version, open the draft version of your study. See Open a study's design.
   • If you need to create a new draft study version, see Create a Draft study version.
2. Determine the type of change you want to make. Ensure that the change is permitted through ASV updates.
3. For each question you add or update, select a study version from the Apply Changes to Study Version drop-down on the Details sidebar.
4. If you removed a question that was used in one or more calculated doses, impacted kit types need to be redefined. You can't update a kit type after a study version has been approved, so you have to:
   1. Define kits with calculated doses.
   2. Update the dispensation schedule so that the appropriate treatment arm uses the new kit type and calculated dose(s).
5. After applying all of your changes, select either Save or Save and Close to save the changes.
6. Select Home to return to the home page, then move the updated study version from Draft to Testing.
   The changes are applied directly to all visits associated with the study version selected in the Apply Changes to Study Version drop-down; this also includes any versions subsequently created.
7. Once testing is complete, move the study version from Testing to Approved.
   The changes are applied directly to all visits associated with the study version selected in the Apply Changes to Study Version drop-down; this also includes any versions subsequently created. The only exception is locked data, which will not be updated until it is unlocked.

   WARNING:

   This is only applicable to changes made using ASV. If your new study version also includes standard study version changes, keep in mind that you are required to manually update the study version assigned to sites, on the Sites & Labs tab, in a study's settings.