How do I activate a study?

Modified on Fri, 25 Apr at 1:23 PM

Learn how to activate a study.

There are two different ways to activate your study:

Option 1

You will have the option to still have a testing version of your study.

⚠️ The subjects entered in your testing study will not be transferred to the active study. However, as mentioned, you have the option to retain collaborators, roles, and sites if needed.

In your Studies Overview, click on "Activate" next to the settings button. A new window will pop up with all required information about default options as well as configuration options for this action.

What will be duplicated by default when activating a study?

Step 1 General: All configurations from the initial study, including study type, language and subject information settings. The user duplicating/activating the study will be the coordinator of the study.

Step 2 Access: Some configurations from the initial study, including the collaborator who duplicates/activates the study with all management rights. The Product Support user is added by default for support. The duplication of all other collaborators, roles and sites are part of the configuration options below.

Step 3 Forms: All configurations from the initial study, including scheduled, unscheduled, (S)AE and sample forms according to enabled modules as well as all form configurations (e.g. field dependencies, signature/locking settings).

Step 4 Workflow: All configurations from the initial study, including study step settings (e.g. step name, forms, form dependencies). For ePro, all settings are duplicated, including channel, message and scheduling configurations. For (S)AEs, all additional workflow settings are duplicated, such as the seriousness definition conditions and pre-filled fields.

Step 5 Trigger Events: All configurations from the initial study, including validations, automated queries, mirrored fields and notifications.

What configuration options do I have when activating a study?

Collaborators: If toggled on, you will give all invited collaborators access to the new active study. Collaborators will receive the same role(s), site(s) as well as management rights assigned to them.

Sites and Roles: If toggled on, you will duplicate all existing sites and roles to the new active study. Activating this option is necessary to duplicate collaborators as collaborators can only exist with assigned role(s) and site(s).

Then click ‘Activate’.

The system will automatically duplicate your Testing Study (with status "In Preparation" or "In Testing") into an Active Study (with status "Active").

This gives you the option to access a test environment while your study is already active.

Option 2

You keep the subjects and collaborators (incl. roles and sites) as is.

⚠️ Unlike option 1, this option does not allow you to keep a testing environment of your study!

In your Studies Overview, click on the "Settings"-button to get to Step 1 of your study.

On the upper left side of this page, you will find the 'Status' property. Here, you can change your Study to 'Active'.

⚠️ Once the study is activated, you cannot revert its status to "In Preparation" or "Testing." However, if you need to make updates while the study is active, you can create a sandbox environment to implement and test your changes before publishing them to the active study (see sandbox details here).

✉️ Still have questions? Feel free to contact your Customer Success Manager or email us at support@climedo.de.