4 Configure a study
After your study design is ready and the appropriate study version is placed in Testing or Approved containers, you can configure your study.
- 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.
- Make a study version available
Make a study version available in Testing mode to begin configuring your study after the study design is ready. Move a study version to Approved after the study design and configuration have been verified and you're ready to make the study live. - 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
Once you have created and configured facilities in your study, study managers and clinical supply managers must specify the study's settings. - Manage randomization
Once you are done setting up sites, depots, labs, and other study settings, a clinical supply manager and other sponsor users can begin configuring settings for the randomization processes of a study. - Manage supplies
After defining randomization, clinical supply managers can define how to manage supplies in the study, including lists, lots and other features. - Make a study live
After all required elements of a study are created, it's time to put all of the pieces together. During this phase, a study team member must assign the appropriate study version to sites, activate sites, and complete many more settings to make a study version live in a specific mode. - Verify a study in Testing mode
After all settings and elements of a study are configured in Testing mode, you must verify that the study design is matching the protocol to proceed with the Production mode configuration. During this phase you must also check the user workflow and make sure everything follows a logical order. - Create and manage custom rules
Oracle Clinical One Platform provides a user interface for creating custom rules using JavaScript. Rules are applied in all modes when published, but you can only create, test, edit, approve and publish them in Testing mode. - Manage dispensation exceptions
While study designers can configure the Do Not Dispense (DND) Days in a study's visit schedule, a sponsor user (typically a clinical supply manager) can configure DND exceptions for a country or site to better control dispensation in a study. Exceptions can be made for all visits where dispensation occurs. - Enable a study for Electronic Health Record (EHR) data import
Enable EHR data import for a study so site users can import EHR data into Oracle Clinical One Platform forms, which can save site users time and improve data quality by reducing data entry mistakes.