Define settings
Once you have created and configured facilities in your study, study managers and clinical supply managers must specify the study's settings.
- 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.
- Enable features specific to the integration with Safety for your study
To begin integrating adverse event data from Clinical One Cloud Service to Safety, you must first enable the Integrate with Safety System toggle for your study. - Specify study, enrollment, and visits settings
Typically, a study manager specifies these settings. With a few exceptions, they can configure settings for all modes simultaneously, while others must be set individually for each study mode. Also note that not all settings can be edited at any time. We recommend you set and verify these settings in Testing mode first. The settings apply to all versions of the study, and this procedure also applies to rollover studies. - Specify settings for Source Data Verification
Source Data Verification (SDV) settings allow you to tailor the level of data verification required for each study and site. These settings apply to all study versions and you can edit them at any time. This procedure is typically done by a study manager and also applies to rollover studies. - Specify supply settings
Typically, a clinical supply manager specifies these settings. These settings apply to all versions of the study and you can edit them at any time. This procedure also applies to rollover studies. - Define signature configurations
Configure how different elements in your study should be signed and by whom. - Configure the connection to Oracle mHealth Connector so you can dispense devices
When a study dispenses IoT-enabled devices managed with Oracle mHealth Connector, you must establish a connection with Oracle mHealth Connector so that data collected from the devices can be sent to the appropriate application. To establish a connection, you enter a user name, password, and URLs for Oracle mHealth Connector. This procedure can also apply to rollover studies, according to how the rollover study is designed.
Parent topic: Configure a study