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.

• Add a locally sourced kit
  Define locally sourced kits for your study's countries.
• Add a region
  You need to add regions to your study to be able to successfully randomize subjects. This procedure can also apply to rollover studies.
• Specify study, enrollment, and visits settings
  Typically, a study manager specifies these settings and it can be done for all modes simultaneously. However, we recommend you set and verify these settings in Testing mode first. These settings apply to all versions of the study and you can edit them at any time. This procedure also applies to rollover studies.`
• How settings are impacted when replacing a subject number with randomization number
  When you replace a subject's number with a randomization number, multiple settings in your study might be impacted.
• Specify enrollment settings for minimization cohorts
  When specifying the enrollment settings, if your study includes a minimization design , the system displays the cohorts in sections by each minimization design. Typically, a study manager specifies these settings. This procedure also applies to rollover studies.
• Manage screening and randomization limits by site
  Study managers can set screening and randomization limits for each site individually.
• Create or edit custom enrollment limits
  Study managers can create custom enrollment limits to restrict subject enrollment based on specific criteria. Custom enrollment limits can be defined in all three modes: Testing, Training, and Production.
• Specify settings for a source data verification strategy
  Typically, a study manager specifies these settings and it can be done for all modes simultaneously. However, we recommend you set and verify these settings in Testing mode first. These settings apply to all versions of the study and you can edit them at any time. This procedure also applies to rollover studies.
• Create a source data verification strategy and assign it to a site
  Your source data verification strategy ensures that partial source data verification is performed for a specific number of subjects and for either all subjects or only critical questions in a study. Source data verification strategies must be associated with a site to become effective. This procedure 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.
• Understand how dose holds work
  Dose holds are crucial when an investigator needs to pause dispensation and respond appropriately to subjects' experiences concerning their health and well being. To make sure this feature is properly configured in a study, several types of users must do their part in creating and applying a dose hold.
• Create or edit a dose hold
  As a clinical supply manager, you can create a dose hold to enable site staff to pause dispensation for a subject due to safety reasons. A dose hold can be created in all three modes: Testing, Training, or Production.
• Create and manage a partial dispensation
  Define partial dispensation settings so that site users are able to complete a visit when there are not enough kits available at the site to dispense. Partial dispensation is only available when the dispensation of multiple kits of the same type is required for the visit and you have at least one kit available of each kit type that must be dispensed.
• Create a min/max resupply strategy
  You create a min/max resupply group to resupply a site or a depot only when their inventory is low. When the application checks inventory, shipments are created as needed to bring the inventory at sites or depots up to the maximum number of kits you specify.
• Create a predictive resupply strategy
  You create a predictive resupply group to resupply a site based on actual enrollment and planned dispensation visits. After running inventory, the application creates shipments to meet each site's inventory requirements for the coming weeks. You specify the number of weeks to consider and the number of weeks to order for. You also set minimum and maximum levels so that sites have sufficient supply for new subjects.
• Create a blinded group of kits
  Create blinded groups if you don't allow single kit ordering, and if the kits in your study use different packaging. Blinded groups determine the kit or kits that are added to a single-kit shipment to protect the study blind. This procedure also applies to rollover studies.
• About signature configurations
  Learn more about creating signature configurations.
• Create a signature configuration
  As a study administrator, create a signature configuration to allow sites to sign off at the form and or visit level using custom affidavits.
• Manage signature configurations at the casebook level
  Define a signature configuration at the casebook level.
• 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.