Operate a clinical study in Oracle Clinical One Platform

Understand the stages of a study flow and how different users collaborate to build a study and manage data in Oracle Clinical One Platform.

Note:

Some of these tasks may not be required depending on your study's objective. Reach out to your Oracle Project Manager for more details about the tasks specific to set up and manage your study.

Create a study and manage users

Tip:

It is not necessary that you create all users in order to start building your study. However, you may want to consider creating your custom study roles at global level before creating the study, so they are included when the study is created.

See Before you configure a study and refer to the Add Users Guide to get more details about user management.

Tasks	Users who typically do this
Create user accounts in Oracle Life Sciences Identity and Access Management Service(IAMS) Provision product roles	Delegated administrator in Oracle Life Sciences Identity and Access Management Service (IAMS)
Create and manage global users in Oracle Clinical One Platform Create study roles at global level	Product Administrator as either: Study Creator (global role) Global User Manager (global role)
Create a study Activate your study	Study Creator (global role)
Create and manage system-level codelists	Code List Manager (global role)
Create a study-level study role Specify data classifications for study roles Add users to your study	Product Administrator as either: Study Creator (global role) Global User Manager (global role) User Administrator

Design a study

See Design a study.

Tasks	Users who typically do this
Create and manage study-level code lists Create forms Create visits and events Add a form to a visit Define the visit schedule Create treatment arms Create the randomization design Create kit types Define the dispensation schedule	Study Designer

Configure a study for Testing mode

Note:

First, you configure your study in Testing mode to verify that the study's settings match your protocol requirements. Once your study version is verified and approved, you can proceed to configure your study in Production and Training modes.

Table 1-2 Set up facilities and define settings

Tasks	Users who typically do this
Make a study version available in Testing mode	Production Administrator Oracle Designer Study Creator (global role) Study Designer
Specify study settings Add regions for region-blocked randomization Specify settings for a source data verification strategy Create a Source Data Verification strategy	Study Manager
Add depots Add sites Specify supply settings Create a resupply strategy	Clinical Supply Manager
Add site and depot users and make sure users are assigned to the correct sites and depots Create labs	User and Site Administrator

For more details, see Set up facilities and Define settings.

Table 1-3 Manage randomization and supplies

Tasks	Users who typically do this
Generate a randomization list	Production Administrator Statistician
Generate a kit list Create manufacturing and blinded lots to manage expiration dates Create label groups and assign kits to them	Clinical Supply Manager

For more details, see Manage randomization and Manage supplies.

Make your study live in Testing mode and verify it

For more details, see Make a study live and Verify a study in Testing mode.

Tasks	Users who typically do this
Specify and review settings before verifying a study Assign a resupply strategy to depots Activate depots	Clinical Supply Manager
Assign a study version to a site Select a resupply strategy for a site Activate sites	Site Administrator
Specify a ship date for automatically generated shipments or release kits to sites or depots	Clinical Supply Manager
Verify a study Note: To verify a study you must add subjects, collect data, manage kits and shipments and run reports. For more information, refer to the Work during the study conduct period chapter and the Site User Guide.	Adding subjects and collecting data require permissions associated with: Site User The rest of the tasks require permissions associated with: Clinical Supply Manager Other sponsor users

Create and manage custom rules

For more details, see Create and manage custom rules.

Tasks	Users who typically do this
Create rules in Testing mode Prepare your rule for testing Test and approve rules Publish a rule	Rules Designer

Configure a study for Production and Training mode

Note:

• 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.

Table 1-4 Set up facilities and define settings

Tasks	Users who typically do this
Make a study version available in Production	Production Administrator
Specify study settings Add regions for region-blocked randomization Specify settings for a source data verification strategy Create a Source Data Verification strategy	Study Manager
Add depots Add sites Specify supply settings Create a resupply strategy	Clinical Supply Manager
Add site and depot users and make sure users are assigned to the correct sites and depots Create labs	User and Site Administrator

For more details, see Set up facilities and Define settings.

Table 1-5 Manage randomization and supplies

Tasks	Users who typically do this
Generate a randomization list	Production Administrator Statistician
Generate a kit list Create manufacturing and blinded lots to manage expiration dates Create label groups and assign kits to them	Clinical Supply Manager

For more details, see Manage randomization and Manage supplies.

Make your study live in Production and Training modes

For more details, see Make a study live.

Tasks	Users who typically do this
Assign a study version to a site Select a resupply strategy for a site Activate sites	Site Administrator
Assign a resupply strategy to depots Activate depots Specify a ship date for automatically generated shipments or release kits to sites or depots	Clinical Supply Manager

Work during the study conduct period

Table 1-6 Manage training of your study team

Tasks	Users who typically do this
Assign and track In-product training	Training Manager
Get trained as you work Practice data entry in Training mode	Sponsor Users Site Users

Table 1-7 Conduct the study

Tasks	Users who typically do this
Add subjects Receive shipments Enter data and dispense kits Manage investigational product	Site User
Manage shipments Manage kits at the site and study level	Clinical Supply Manager
Monitor subjects and sites Create and manage queries Archive a study version and decommission a study	Sponsor Users
Run and download a report, data extract, or archive	Sponsor Users Site Users
Analyze data and share your insights with Oracle Clinical One Analytics	Data Manager Other sponsor users

For more information, see Work during the study conduct period, the Site User Guide and the Analytics User Guide.

Table 1-8 Update the study's design during the study conduct period

Tasks	Users who typically do this
Create a new Draft version of a study to update the Approved version Manage study versions during the study conduct period Update forms and visit schedule during the study conduct period	Study Designer
Update randomization and kit types definitions during the study conduct period	Study Designer Statistician Clinical Supply Manager
Update subject settings during the study conduct period	Study Manager

For more details, see Updates during the study conduct period.