How Ethica Deals with Mid-Study Changes

Mid-study changes refer to the adjustments that take place after a clinical trial or study starts the participant enrollment. They include modifying the existing surveys such as re-evaluating their prompt times or making adjustments to their skip patterns. They may also involve adding or removing the type of data to be collected, or changes to the informed consent process. In this post, we will explain why this is important and how it can be done.

Mid-study changes may be complex, and require a great deal of thought and planning on how it may impact the existing participants, and how it can impact the post-study data analysis. That’s why it’s often considered a good practice to limit these changes to a minimum. However, in most studies such changes are inevitable. So at Ethica, we have been working to provide tools to make such changes error-free, and offer a smooth protocol-update for the existing participants. When such changes are introduced to a study with active participants, our first and foremost advice is to make sure all currently enrolled participants are updated with these changes.

Reloading Study Settings on Participants' Devices

Ethica apps for Android and iPhone are capable of working offline. To do so, the app occasionally connects to the server, downloads all the study settings, and uses those settings as the basis for its operation. If you modify the study settings while the participants are already enrolled in the study, you make these settings out of sync. You can wait for each participant's app to sync itself with the latest changes, or you can ask Ethica to reload the settings on the participant's device as soon as possible.

To reload the participants' devices as soon as possible, go to the Participation page from the researcher dashboard, select the participants, and click on Reload Device.

Following this, Ethica sends a message to their device and performs the reload. The message is often received by the app right away, or as soon as they get online, and the participant’s device gets the latest changes.

But the problem is that some participants may be offline. This happens specially when the subject demographic is not expected to have continuous Internet connectivity. In this case, it's better if you reach out to the participants (e.g. via a phone call) and ask him or her to reload studies from their Ethica app.

To do this, they need to open the Ethica app and click on the Settings icon located in the top-right corner of the home screen.

Next, the participant should tap on the My Studies menu item.

And finally, they should press the RELOAD STUDIES FROM SERVER button to reload their study details from the server.

Wrap up

Mid-study changes are believed to be one of the most challenging, yet inevitable parts of conducting studies, particularly studies that have complex designs. Ethica will help you deploy the changes with minimal disruptions. The solution explained above is a simple method to make sure participants’ study settings are in sync with the latest settings on the server.

In the upcoming releases of Ethica, we are working on adding different versions to studies to better control such changes. Furthermore, we are working to enable researchers to define how the transition of a given participant between each of these versions should be done. So, stay tuned.