Set up facilities
During this phase, you must set up the facilities involved in your study, such as sites, depots and labs. We recommend to use mock facilities in Testing mode to avoid confusions when receiving notifications.
- Define settings for Testing mode first, so you can test and verify a study version using mock data.
- Configure settings for Production mode once you have verified that the study design and settings are working as expected.
- Configure Training mode settings to match those defined for Production mode, so that users who operate your study can get properly trained with the real study configuration using mock data.
- Add a depot for a study
With depots created at your organization, you can select a depot's details to associate it with your study, too. - Edit a depot at a study level
You can modify certain details of a depot at the study level - Delete a depot at a study level
If necessary, a study-level depot can be deleted by a sponsor or CRO user. - Add a site to a study
A site is created at a global level as an institution, making it available for use by multiple studies at your organization. Furthermore, as a site manager, you can add sites to your study and configure more details for the institution and the site staff. - Edit a site at the study level
You can modify certain details of a site at the study level. - Delete a site at the study level
If necessary, a study level site can be deleted by a sponsor or CRO user. - Manage site permissions
You can limit the activities a site user can perform, such as adding new subjects, screening and randomizing subjects or dispensing kits. - Manage screening and randomization limits by site
Study managers can set screening and randomization limits for each site individually. - Add a lab to a study
You can associate a local laboratory with your site. This allows you to associate lab normals with commonly used laboratories and quickly select these labs when adding subject test data. You can add and edit local laboratories at any time, without creating a new version of a study. - Define lab normals
Once you have added a laboratory to your site, you can define the standard values that lab applies to collected lab results. These values are also known as lab normals. - How are lab normal updates reflected in existing lab forms?
If you update lab normal values during a study's conduct period, these updates are reflected in all started lab forms, including existing ones, whether complete or not. - Assign a local lab to a site
Site managers or other sponsor users can assign a local laboratory to a site. - Make sure users are assigned to the correct sites and depots
Sometimes users are created before sites and depots are set up. If your study followed that workflow, make sure you assign everyone to the appropriate sites and depots after the sites and depots are created.
Parent topic: Configure a study