Update a form during the study conduct period

Updates to forms appear for all subjects, including on pages where data was already collected. This procedure also applies to rollover studies.

Task 1   Create a new Draft version of a study

Create a new study version in Draft so you can edit your study's design. For step-by-step instructions, see Create a new Draft study version.

Task 2   Update the Draft version of the study

1. Update the form.
2. To apply the update to an existing live study version, on the right, from the Apply Change to Version drop-down select the study version to which you want to apply the changes. The update will apply to the study version you selected and to all study versions that were subsequently created.

   Note:

   Not all form changes may apply to Advance Study Versioning (ASV). To see what types of changes are allowed or not in a live study version, refer to About Advanced Study Versioning (ASV).
3. 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).

Task 3   Make the new study version live

Tasks include:

1. Make a study version available in Testing mode.
2. Verify the study.
3. Make a study version available in Production and Training modes. Once the new version is moved to the Approved container, the form updates also become available in the study version you selected from the Apply Change to Version drop-down and to all sites to which that study version is assigned.

Note:

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.

Also note that 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 item will be hidden. If the determining question is updated to the criteria to show the dynamic item, that item appears and the original data is still there.