Update and manage changes in a live study

Study designers can now update a form in a live study retrospectively. This allows you to make changes to forms within your study without changing the study version.

What are the benefits?

As a study designer, you can now modify a form in a live study version without changing the study version. This new feature gives you the ability to make changes to currently live study versions while data is being actively collected in the system. These changes can even be applied to completed forms. This ability gives you more flexibility when it comes to planning your study design and allows you to quickly integrate minor or unplanned study changes into multiple study versions without going through the entire study versioning process.

As an example, let's say you need to add a new question to a form that is included in a live study version (1.0.0.1). Data is already being collected on that form so you need to apply the change for all subjects, including those that already started or completed the form. You first create a new study version (1.0.0.2) and make the necessary changes to your form in Draft mode. When you edit the form you now have the option to apply the change directly to an existing live version (in our example, version 1.0.0.1). Once the new study version (1.0.0.2) is moved to the Approved container, the update automatically becomes available in the previous study version (1.0.0.1). You don't need to update the study version (1.0.0.1) for sites already on that version. Your updates appear for all subjects, including where data has already been collected. If the form you just updated was already completed by any of the subjects during the study, site users must go back to that form and enter answers for any questions you added or modified.

Details for study designers

Your workflow for updating a live study includes a couple of changes.

Whenever you want to edit a form used in a live study version, you must use the new setting that allows you to apply the change to an existing live study version. When you click the Apply Change to Version drop-down, a list of all study versions in Testing, Approved, and Archived appears.

Once the new version is moved to the Approved container, the update also becomes available in the study version you selected when editing the form and to all sites to which that study version is assigned. Additionally, the change will apply to all study versions created after the study version you selected in the Apply Change to Version drop-down. That is, your change applies to the version you select as well as any version created more recently.

Details for site users

From now on, form design can be updated retrospectively. This means that forms you already completed, can become incomplete if a required item is later added to the form. The change becomes available only after you enter the visit and access the form. You can edit the form and click Save.

Already working in a live study?

As soon as the upgrade for this release is complete, you can start to retroactively modifying forms in live studies for existing and newly created forms.