Manage study versions during the study conduct period
- Create a new Draft study version
Create a new Draft study version anytime you need to update your study's design. - Create a new Draft version of a study to update the Testing version
Create a new Draft version of a study when you need to update a study version that you've already moved to Testing on the Home page. You can modify details about the study, including its title, phase, and blinding status at any time, without creating a new version of a study. This procedure also applies to rollover studies. - Make a study version available in Testing mode
Make a study version available in Testing mode after you finish configuring the study. After the study version is available in Testing mode, you can create sites and depots, specify subject and supply settings, and create a randomization list and kit list. This procedure also applies to rollover studies. - Create a new Draft version of a study to update the Approved version
Create a new Draft version of a study when you need to update a study version that has already been moved to Approved on the Home page. You can modify details about the study, including its title, phase, and blinding status at any time, without creating a new version of a study. This procedure also applies to rollover studies. - Make a study version available in Production and Training modes
Move a study version to Approved after the study design is finished and configuration is verified to be compliant with the study protocol. Some study design activities aren't allowed after you move a study version to Approved, even if you create a new Draft version of the study. - Update the study version that is assigned to a site
Before updating the study version that is assigned to a site, make sure the site has signed off on the new study version, if this process is required, and make sure that regional regulatory requirements are in place. This procedure also applies to rollover studies. - Archive an Approved version of a study
Before archiving an Approved version of a study, make sure all sites have been assigned to a new version of the study. This procedure can also apply to rollover studies.
Parent topic: Updates during the study conduct period