Platform Oracle® Health Sciences Clinical One Add Users › en › industries › health...Contributors: (contributor), (contributor) ... Task 1 Activate approvals, and publish roles

Oracle® Health Sciences Clinical OnePlatformAdd Users

Release 20.2F32168-01June 2020

Oracle Health Sciences Clinical One Platform Add Users, Release 20.2

F32168-01

Copyright © 2017, 2020, Oracle and/or its affiliates.

Primary Authors: (primary author), (primary author)

Contributing Authors: (contributing author), (contributing author)

Contributors: (contributor), (contributor)

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Contents

Preface

Documentation accessibility v

Related resources v

Access to Oracle Support v

Additional copyright information v

1 I manage users for Oracle Clinical One Platform. Where do I start?

Who this guide is for 1-1

START HERE: Workflow for adding users 1-1

How to access the products 1-3

2 Activate approvals, and publish roles

Step 1. Activate approval for the Oracle Clinical One Platform roles in Oracle HealthSciences Identity and Access Management Service 2-1

Step 2. Publish the Oracle Clinical One Platform roles 2-2

3 Create a single sign-on account for each user

Create an SSO account for a site user who also works in Oracle InForm 3-1

Step 1. Create a user 3-1

Step 2. Assign roles to a user 3-2

Create an SSO account for all other users 3-5

Step 1. Create a user 3-5

Step 2. Assign roles to a user 3-7

Step 3. Review and approve an access request 3-10

Step 4. Notify the administrator that they can start working in Oracle ClinicalOne Platform 3-11

4 Create global users

Create a global user 4-1

iii

5 Add a user to a study

Learn: Typical role, site and depot assignments 5-2

6 Learn: Descriptions of each role

Site user roles 6-1

Study team: Study design roles 6-5

Study team users: Blinded roles 6-7

Study team users: Unblinding roles 6-11

Oracle employee roles 6-14

7 Learn: Frequently asked questions (FAQs)

Can I update a user's account after creating it? 7-1

Do I need to revoke access for SaaS Services users after collaboration is complete?7-1

Do I need to revoke access for Health Sciences Support users after a ticket isresolved? 7-1

How do I control users' access to the application? 7-1

What happens if I change the roles that a user is assigned to while the user islogged in? 7-2

iv

Preface

This preface contains the following sections:

• Documentation accessibility

• Related resources

• Access to Oracle Support

• Additional copyright information

Documentation accessibilityFor information about Oracle's commitment to accessibility, visit theOracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Related resourcesAll documentation and other supporting materials are available on the Oracle HelpCenter.

Access to Oracle SupportOracle customers that have purchased support have access to electronic supportthrough Support Cloud.

Contact our Oracle Customer Support Services team by logging requests in one of thefollowing locations:

• English interface of Oracle Health Sciences Customer Support Portal (https://hsgbu.custhelp.com/)

• Japanese interface of Oracle Health Sciences Customer Support Portal (https://hsgbu-jp.custhelp.com/)

You can also call our 24x7 help desk. For information, visit http://www.oracle.com/us/support/contact/health-sciences-cloud-support/index.html or visithttp://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.

Additional copyright informationThis documentation may include references to materials, offerings, or products thatwere previously offered by Phase Forward Inc. Certain materials, offerings, services,or products may no longer be offered or provided. Oracle and its affiliates cannot beheld responsible for any such references should they appear in the text provided.

v

http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc

http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc

https://docs.oracle.com/en/industries/health-sciences/clinical-one/index.html

https://docs.oracle.com/en/industries/health-sciences/clinical-one/index.html

https://hsgbu.custhelp.com/

https://hsgbu.custhelp.com/

https://hsgbu-jp.custhelp.com/

https://hsgbu-jp.custhelp.com/

http://www.oracle.com/us/support/contact/health-sciences-cloud-support/index.html

http://www.oracle.com/us/support/contact/health-sciences-cloud-support/index.html

http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs

1I manage users for Oracle Clinical OnePlatform. Where do I start?

• Who this guide is for

• START HERE: Workflow for adding users

• How to access the products

Who this guide is forThis document is for anyone who needs to add users for Oracle Clinical One Platformor Oracle Clinical One Integration Hub, including:

• A delegated administrator, who provisions and administers Oracle Clinical OnePlatform and Oracle Clinical One Integration Hub users in Oracle Health SciencesIdentity and Access Management Service or Oracle User Management Tool.For complete instructions on working in Oracle Health Sciences Identity andAccess Management Service, see the Oracle Health Sciences Identity and AccessManagement Service Administrator Guide.

• A Oracle Clinical One Platform administrator who creates global users and studyteam members in Oracle Clinical One Platform.

• A study team member who creates site and depot users in Oracle Clinical OnePlatform.

START HERE: Workflow for adding usersNew to Oracle Clinical One Platform or Oracle Clinical One Integration Hub? We'vegot step-by-step instructions that tell you what to do and why you do it.

Stop! Are you using HS Learn - Manager or Oracle Clinical One Platform only tomanage training for Oracle Health Sciences products? Follow the instructions in theQuick Training Setup guide instead.

Task 1 Activate approvals, and publish rolesBefore you can start creating users, you need to set up your roles in Oracle HealthIAM (Oracle Health Sciences Identity and Access Management Service) so thatOracle can request access to your roles and so that you can choose whether theyget access.Oracle Health IAM is the product where organization-wide delegated administratorscan manage user accounts and user access to your Oracle Clinical One Platform andstudies that are hosted in Global Business Unit Cloud Services (GBUCS).Learn more.

1-1

https://docs.oracle.com/en/industries/health-sciences/identity-access-management-service/admin-guide/administrator-guide1.html#GUID-DFD84092-5793-4582-87AE-1CF828E7161A

https://docs.oracle.com/en/industries/health-sciences/identity-access-management-service/admin-guide/administrator-guide1.html#GUID-DFD84092-5793-4582-87AE-1CF828E7161A

https://docs.oracle.com/en/industries/health-sciences/clinical-one/quick-training-setup/index.html

Task 2 Create a single sign-on account for each userNow you can start adding users! The first step is to create a single-sign on accountfor each user. You create just one single sign-on (SSO) account for each user, but theplace where you create the accounts might vary:

• For site users who need to work in Oracle InForm now or in the futureCreate SSO accounts in the Oracle User Management Tool, and assign roles tousers in Oracle Health Sciences Identity and Access Management Service.

Learn more.

• For all other users who need to work in Oracle InForm now or in the futureCreate SSO accounts and assign roles to the users in Oracle Health SciencesIdentity and Access Management Service.

Learn more.

What if a sponsor user works in both Oracle InForm and Oracle ClinicalOne Platform? Where to create the SSO account is up to you. You can work ineither Oracle User Management Tool or Oracle Health Sciences Identity and AccessManagement Service. If the user's SSO account was already created in Oracle UserManagement Tool, you don't need to create another SSO account, but you do need toassign appropriate roles to the user in OHSIAMS Oracle Identity Self Service.

Task 3 Create one or more global users in Oracle Clinical One PlatformNow it's time to sign in to Oracle Clinical One Platform and create a few global users.Global users might not have superpowers, but they can do tasks for every study,including creating studies, giving users access to them, and setting up integrations.Stop! Are you using Oracle Clinical One Integration Hub only? If so, you're finishedsetting up users! Users can start signing in and working. If you're using Oracle ClinicalOne Platform to create a clinical study, you've got a few more steps to get everyoneready to work.Learn more.

Task 4 Create one or more site and user managers for each study in OracleClinical One PlatformGlobal users can add a user to any study, but they can't assign users to individualsites and depots. Only site and user managers can do that, so a global user needsto create at least one site and user manager in each study and assign them to all thesites and depots that they need to assign to users. For instance, one site and usermanager might add the study team to the study, and another site and user managermight add all site and depot users.Or one person can do everything! An administrator can create their single sign-onaccount in Oracle Health Sciences Identity and Access Management Service, addthemselves as a global user, add themselves as a site and user manager for eachstudy (and assign themselves to all sites and depots), and then start adding the studyteam as well as site and depot users.Read more about site and user managers.Learn more about adding a user to a study.

Task 5 Add the remaining members of the study teamA global user or a site and user manager can add everyone at your organization.Read more about study team members.Learn more about adding a user to a study.

Task 6 Add all site and depot usersA global user or a site and user manager can add all the site and depot users.

Chapter 1START HERE: Workflow for adding users

1-2

Read more about site and depot users.Learn more about adding a user to a study.

Task 7 Now everyone can sign inYou did it! Now users can sign in and start working.

How to access the productsCredentials for each product

• Use your single sign-on (SSO) account to sign in to Oracle Health SciencesIdentity and Access Management Service, Oracle Clinical One Platform, andOracle Clinical One Integration Hub.

• Use your Oracle User Management Tool account to sign in to Oracle UserManagement Tool.

Oracle Health Sciences Identity and Access Management Service

How do I get access to Oracle Health Sciences Identity and Access ManagementService? The business operations group from Oracle requests information from yourorganization, including your name and email address, so that you can be given accessto Oracle Health Sciences Identity and Access Management Service. After you getaccess to Oracle Health Sciences Identity and Access Management Service, you'llreceive a welcome letter over email with information about how to sign in.

How do I open Oracle Health Sciences Identity and Access ManagementService? You can do this in several ways:

• All users: You can navigate directly to Oracle Health SciencesIdentity and Access Management Service at https://<ShortOrgId>-hs-identity.oracleindustry.com/identity. Your ShortOrgId appears in bold font in theNew Account email message that you received when your account was created.

• If your organization does not use My Oracle Bookmarks, you can:

1. Follow the link from the New Account Password email message.The Landing Page opens.

2. On the left, under Quick Links, click Update Profile to open Oracle HealthSciences Identity and Access Management Service.

• If your organization uses My Oracle Bookmarks, you can:

1. Follow the link from the New Account Password email message.My Oracle Bookmarks opens.

2. If there is a tile for Oracle Health Sciences Identity and Access ManagementService, click the tile.If there is no tile for Oracle Health Sciences Identity and Access ManagementService, click your name in the top right and select Account Management.

Oracle Clinical One Platform

Your welcome letter includes the URL for accessing Oracle Clinical One Platform.All Oracle Clinical One Platform users at your organization use the same URL. Youshould make the URL available to all your Oracle Clinical One Platform users.

Chapter 1How to access the products

1-3

Oracle Clinical One Integration Hub

A member of the SaaS Services team provides the URL during the onboardingprocess. You should make the URL available to all your Oracle Clinical One IntegrationHub users.

Oracle User Management Tool (required only for creating some Oracle InFormusers)

You'll receive 2 email messages from Oracle:

• One message has the URL and your user name for accessing Oracle UserManagement Tool.Your account for Oracle User Management Tool is different from the account youuse for Oracle Health Sciences Identity and Access Management Service, OracleInForm, and Oracle Clinical One Platform.

• Another message has a temporary password.

Chapter 1How to access the products

1-4

2Activate approvals, and publish roles

• Step 1. Activate approval for the Oracle Clinical One Platform roles in OracleHealth Sciences Identity and Access Management Service

• Step 2. Publish the Oracle Clinical One Platform roles

Step 1. Activate approval for the Oracle Clinical OnePlatform roles in Oracle Health Sciences Identity andAccess Management Service

Want to understand how this task fits in the overall workflow for adding users?

Learn more about this step

• Who does it? A delegated administrator at your organization.

• When do I do this? After you get access to Oracle Health Sciences Identity andAccess Management Service, or whenever a new role becomes available.

• Do I have to do this? It depends:

– If you're using Oracle Health Sciences Learn Manager only to createtraining studies for other products, such as Oracle InForm, Oracle CentralDesigner, Oracle Central Coding, Oracle IRT, and Oracle User ManagementTool, you can opt to not activate approval for the roles. Leaving approvalinactivated will simplify the provisioning process because you won't needsomeone else to approve access requests when assigning the roles.

– If you're using Oracle Clinical One Platform to create clinical studies,or if you're using Oracle Clinical One Integration Hub to manageintegrations, this step is required. Activating approval lets you control whogains access to Oracle Clinical One Platform. When one of your employeesor an Oracle employee who doesn't have access to your instance of OracleClinical One Platform navigates to the product URL, they can submit anaccess request. With approval activated, someone at your organization willhave to approve the request before the user can get access. Without approval,access is granted automatically.

1. Submit a request to Health Sciences Support to create the Approver role for yourorganization.

2. After the Approver role is available, assign it to at least two users.

For instructions, see Create a user.

3. Open Oracle Health Sciences Identity and Access Management Service:

https://<ShortOrgId>-hs-identity.oracleindustry.com/identity

2-1

Where

<ShortOrgId>

is the short name for your organization. This value is defined when yourorganization is added to Oracle Health Sciences Identity and Access ManagementService.

4. Follow the instructions in Activate approval for a role for each of the followingroles:

Note:

In Oracle Health IAM, you will only see the roles that correspondto the environment that you're provisioned in. For example,you either see clinicalone-CNE, clinicalone-CNE_AssignGlobalRoles,and inthub-CNE roles, or you see ClinicalOne_Production,ClinicalOne_Production_AssignGlobalRoles, IntegrationHub_Productionand IntegrationHub_UI_Production roles. Choose the set of roles thatappear in your Oracle Health IAM application. If you encounter anyissues in activating approval for the roles mentioned above, reach outto Health Sciences Support.

• ClinicalOne_Production

• ClinicalOne_Production_AssignGlobalRoles

• IntegrationHub_Production

• IntegrationHub_UI_Production

• clinicalone-CNE

• clinicalone-CNE_AssignGlobalRoles

• inthub-CNE

Step 2. Publish the Oracle Clinical One Platform rolesWant to understand how this task fits in the overall workflow for adding users?


• Who does it? A delegated administrator at your organization.

• When do I do this? After you activate approval for roles.

• Do I have to do this? Yes. Publication lets Oracle users see the Oracle ClinicalOne Platform and Oracle Clinical One Integration Hub roles in Oracle HealthSciences Identity and Access Management Service so they can assign them asnecessary to SaaS Services and Health Sciences Support users. And becauseyou activated approval, you'll see an access request for each assignment, and youcan approve or reject each request.

1. Go to Oracle Health Sciences Identity and Access Management Service andfollow the instructions in Grant external access to company applications or studies.Publish each of the following roles to the oracle organization:

Chapter 2Step 2. Publish the Oracle Clinical One Platform roles

2-2

In Oracle Health IAM, you will only see the roles that correspondto the environment that you're provisioned in. For example,you either see clinicalone-CNE, clinicalone-CNE_AssignGlobalRoles,and inthub-CNE roles, or you see ClinicalOne_Production,ClinicalOne_Production_AssignGlobalRoles, IntegrationHub_Productionand IntegrationHub_UI_Production roles. Choose the set of roles that appearin yourOracle Health IAM application. If you encounter any issues inactivating approval for the roles mentioned above, reach out to HealthSciences Support.


• ClinicalOne_Production_AssignGlobalRoles

• clinicalone-CNE_AssignGlobalRoles

Note:

You have to publish this role, even though no one can requestaccess to it. Here's why: Oracle employees can see the role andassign it as needed to Oracle employees only if you publish it. Someusers at your own organization will need the role, too, and you'll haveto assign it to them directly.

No one can request access to this role, but you still have to publish it so thatOracle can see the role and assign it as needed to Oracle employees.



• clinicalone-CNE

• inthub-CNE

Tip:

You need to publish each role only one time.

2. Tell your Oracle project manager that the roles are visible so that Oracleemployees who need to can request access by following the Oracle Clinical OnePlatform URL in your welcome letter.

If you are allowing internal users to request access, you can provide the URLto those users, as well. Also, because you have activated approval, an accessrequest is created whenever someone requests a role for themselves or others.Your users who have the Approver role must review and approve valid accessrequests to grant the requested role.

Chapter 2Step 2. Publish the Oracle Clinical One Platform roles

2-3

3Create a single sign-on account for eachuser

• Create an SSO account for a site user who also works in Oracle InForm

• Create an SSO account for all other users

Create an SSO account for a site user who also works inOracle InForm

• Step 1. Create a user

• Step 2. Assign roles to a user

Step 1. Create a userWant to understand how this task fits in the overall workflow for adding users?


• Who does this? A user with access to Oracle User Management Tool.

• When do I do this? When you need to add a site user who also works (or willwork) in Oracle InForm.

• Which users do I need to create? In Oracle User Management Tool, you createSSO accounts for all site users who work in both Oracle Clinical One Platform andOracle InForm, including site users who will work in Oracle InForm in the future.How do I create SSO accounts for other users?

• Where do I create SSO accounts for sponsor users who also work in OracleInForm? It's up to you. You can work in either Oracle User Management Tool(where you manage all Oracle InForm users) or Oracle Health Sciences Identityand Access Management Service (where you manage all Oracle Clinical OnePlatform users).

• What if I already created a user's SSO account in Oracle User ManagementTool? You don't need to create another SSO account, but you do need to assignthe appropriate roles to the user in Oracle Health Sciences Identity and AccessManagement Service.

• Do I have to do this? Yes. You need to create a single sign-on account for eachuser. Users will use their single sign-on accounts to sign in to Oracle Clinical OnePlatform, Oracle InForm, and Oracle Clinical One Integration Hub.

• Determine whether Oracle has created the trial for you in Oracle UserManagement Tool. You must submit a request for the trial to be created.

• If the trial has been created, create each user's SSO account in Oracle UserManagement Tool by creating a study user.

3-1

For step-by-step instructions, see Creating Oracle InForm User ManagementTool users.

• If the trial hasn't been created, create each user's SSO account in Oracle UserManagement Tool by creating a global user.For step-by-step instructions, see Creating global users.

Step 2. Assign roles to a userWant to understand how this task fits in the overall workflow for adding users?

Show me how!


• Who does this? A delegated administrator at your organization.

• When do I do this? After you create a single sign-on account for a user, eitherin Oracle User Management Tool for site users who work in Oracle InForm, orin Oracle Health Sciences Identity and Access Management Service for all otherusers.

• Which users do I need to assign roles to? Every user with a single sign-onaccount, including all users at the sponsor, site, and depot.

• Do I have to do this? Yes. You created single sign-on accounts for each user, butthe users need the appropriate roles to be able to sign in to either Oracle ClinicalOne Platform or Oracle Clinical One Integration Hub.

• Do I need to assign separate roles for each study? No. The roles that areavailable in Oracle Health Sciences Identity and Access Management Service forOracle Clinical One Platform and Oracle Clinical One Integration Hub grant rightsfor each product as a whole. They are not study-specific. An Oracle Clinical OnePlatform administrator must further assign study-specific rights to users from withinClinical One.

Option 1. Ask users to navigate to your product URL and submit an accessrequestIf you activated approval for a role and published the role, users can request accessthemselves.

1. All Oracle Clinical One Platform users must perform these steps:

a. Navigate to the Oracle Clinical One Platform product URL.

b. Sign in with their single sign-on user name, type a justification, and submit it.An access request is created for the ClinicalOne_Production orclinicalone-CNE role.

2. All Oracle Clinical One Integration Hub users must perform these steps:

a. Navigate to each of the following product URLs, one at a time:

• Oracle Clinical One Platform product URL

• Oracle Clinical One Integration Hub URL with the following format:<org>-clinicaloneinthub.oracleindustry.com

Chapter 3Create an SSO account for a site user who also works in Oracle InForm

3-2

https://docs.oracle.com/en/industries/health-sciences/user-management-tool/user-guide/creating-umt-users.html

https://docs.oracle.com/en/industries/health-sciences/user-management-tool/user-guide/creating-umt-users.html

https://docs.oracle.com/en/industries/health-sciences/user-management-tool/user-guide/creating-global-users.html

http://apexapps.oracle.com/pls/apex/f?p=44785:265:0::::P265_CONTENT_ID:26102

• Oracle Clinical One Integration Hub URL with the following format:<org>-inthub.oracleindustry.com

b. For each URL, sign in with their single sign-on user name, type a justification,and submit it.Access requests are created for the following roles (respectively):




• clinicalone-CNE

• inthub-CNE

Note:

Users can't request the administration role (AssignGlobalRoles), which isrequired if users are responsible for creating studies and global users inOracle Clinical One Platform; or if they are training administrators, whocreate training managers users in Oracle Clinical One Platform. For thisrole, you must do one of the following:

• Assign this role to users individually. Keep reading for instructions.

• Assign this role using a bulk import. See Perform user operations inbulk.

Option 2. Assign roles to users yourself

1. Open Oracle Health Sciences Identity and Access Management Service:https://<ShortOrgId>-hs-identity.oracleindustry.com/identity

where <ShortOrgId> is the short name for your organization. This value is definedwhen your organization is added to Oracle Health Sciences Identity and AccessManagement Service.

2. Under Administration, click Users.

3. Enter search criteria for the user. For example:

• From the E-mail drop-down, select Equals, and type the user's emailaddress.or

• From the Display Name drop-down, select Equals, and type the user'sdisplay name.

4. Click Search, located below the filtering fields and to the right.

5. In the Search Results table, find the user, and in the User Login column, click theuser's name.

6. On the User Details page, select the Roles tab.

7. From the Actions drop-down, located above the table of roles, select Request.


3-3

8. Use the following questions to determine the roles that the user needs:

• Oracle Clinical One Platform users at organizations that use OracleClinical One Platform to create clinical studiesAssign the ClinicalOne_Production or clinicalone-CNE role to everyonewho needs to work in Oracle Clinical One Platform.

Note:

Some organizations use Oracle Clinical One Platform both to createclinical studies and to create training studies. If your organizationuses Oracle Clinical One Platform for both purposes, all users stillneed the ClinicalOne_Production or clinicalone-CNE role.

• Oracle Clinical One Platform users at organizations that use OracleClinical One Platform to create training studiesIf the user is responsible for creating studies and global users in OracleClinical One Platform; or if the user is a training administrator, who createstraining managers users in Oracle Clinical One Platform, you must assign thefollowing roles:

– ClinicalOne_Production or clinicalone-CNE

– ClinicalOne_Production_AssignGlobalRoles or clinicalone-CNE_AssignGlobalRolesClinicalOne_Production_AssignGlobalRoles and clinicalone-CNE_AssignGlobalRoles are role names; you might also see theirDisplay Name, AssignGlobalRoles, in Oracle Health Sciences Identityand Access Management Service.

Note:

Usually, only a limited number of users need an administrative role.Users who have this role for an application instance have access toGlobal Settings and can give other users access to studies in thatinstance of Oracle Clinical One Platform.

• Oracle Clinical One Integration Hub usersIn Oracle Health IAM, you will only see the roles thatcorrespond to the environment that you're provisioned in. Forexample, you either see clinicalone-CNE and inthub-CNE roles,or you see ClinicalOne_Production, IntegrationHub_Production andIntegrationHub_UI_Production roles. Choose the set of roles that appear inyour Oracle Health IAM application. If you encounter any issues in selectingroles, reach out to Health Sciences Support.

If the user is responsible for creating and configuring integrations managedthrough Oracle Clinical One Integration Hub, you must assign the followingroles:


3-4

– ClinicalOne_Production

– IntegrationHub_Production

– IntegrationHub_UI_Production

– clinicalone-CNE

– inthub-CNE

9. You've determined the roles the user needs; now it's time to find them and assignthem:

a. In the search box, type the name of the role and press Enter.

b. To the right of the role, click Add to Cart.

c. Add any additional roles the user requires.

10. In the upper-right, click Checkout.

11. Review the roles in the cart.

12. In the upper-right, click Submit.The Request Summary page opens, and a confirmation message appears at thetop of the page.

13. (If your organization has activated approval for the requested role) Ask someonewith the Approver role to approve the access requests so that the userreceives the role(s) you assigned. You cannot approve your own requests,so someone else at your organization with the Approver role must approvethem.

Create an SSO account for all other users• Step 1. Create a user

• Step 2. Assign roles to a user

• Step 3. Review and approve an access request

• Step 4. Notify the administrator that they can start working in Oracle Clinical OnePlatform

Step 1. Create a userWant to understand how this task fits in the overall workflow for adding users?



• When do I do this? When you need to add a new user for Oracle Clinical OnePlatform or Oracle Clinical One Integration Hub.

• Which users do I need to create? In Oracle Health Sciences Identity and AccessManagement Service, you create SSO accounts for sponsor users, depot users,and site users who don't work in Oracle InForm.How do I create SSO accounts for site users who work in Oracle InForm ?

• What if a sponsor user also works in Oracle InForm? Where to create theirSSO account is up to you. You can work in either Oracle User Management Tool(where you manage all Oracle InForm users) or Oracle Health Sciences Identity

Chapter 3Create an SSO account for all other users

3-5

and Access Management Service (where you manage all Oracle Clinical OnePlatform users).

• Do I have to do this? Yes. You need to create a single sign-on account for eachuser. Users will use their single sign-on accounts to sign in to Oracle Clinical OnePlatform and Oracle Clinical One Integration Hub.

Option 1. Create user accounts one at a timeCreate user accounts one at a timeShow me how!For step-by-step instructions, see Create a user account.

Option 2. Provision users using a bulk importA bulk import can save you some time, and you can use it to create users and assignroles to new or existing users.For step-by-step instructions, see Perform user operations in bulk.Before you start: If you're using a bulk import both to create users and to assignroles them, you'll need to know the roles to assign. Use the following questions tofigure out the roles that each user needs:

• Oracle Clinical One Platform users at organizations that use Oracle ClinicalOne Platform to create clinical studiesAssign the ClinicalOne_Production or clinicalone-CNE role to everyone whoneeds to work in Oracle Clinical One Platform.

Note:

Some organizations use Oracle Clinical One Platform both to createclinical studies and to create training studies. If your organization usesOracle Clinical One Platform for both purposes, all users still need theClinicalOne_Production or clinicalone-CNE role.

• Oracle Clinical One Platform users at organizations that use Oracle ClinicalOne Platform to create training studiesIf the user is responsible for creating studies and global users in Oracle ClinicalOne Platform; or if the user is a training administrator, who creates trainingmanagers users in Oracle Clinical One Platform, you must assign the followingroles:


– ClinicalOne_Production_AssignGlobalRoles or clinicalone-CNE_AssignGlobalRolesClinicalOne_Production_AssignGlobalRoles and clinicalone-CNE_AssignGlobalRoles are role names; you might also see their DisplayName, AssignGlobalRoles, in Oracle Health Sciences Identity and AccessManagement Service.


3-6


Tip:


• Oracle Clinical One Integration Hub usersIn Oracle Health IAM, you will only see the roles that correspond tothe environment that you're provisioned in. For example, you either seeclinicalone-CNE and inthub-CNE roles, or you see ClinicalOne_Production,IntegrationHub_Production roles. Choose the set of roles that appear in yourOracle Health IAM application. If you encounter any issues in selecting roles,reach out to Health Sciences Support.

If the user is responsible for creating and configuring integrations managedthrough Oracle Clinical One Integration Hub, you must assign the following roles:



– clinicalone-CNE

– inthub-CNE

Step 2. Assign roles to a userWant to understand how this task fits in the overall workflow for adding users?



• When do I do this? After you create a single sign-on account for a user, eitherin Oracle User Management Tool for site users who work in Oracle InForm, orin Oracle Health Sciences Identity and Access Management Service for all otherusers.

• Which users do I need to assign roles to? Every user with a single sign-onaccount, including all users at the sponsor, site, and depot.

• Do I have to do this? Yes. You created single sign-on accounts for each user, butthe users need the appropriate roles to be able to sign in to either Oracle ClinicalOne Platform or Oracle Clinical One Integration Hub.

• Do I need to assign separate roles for each study? No. The roles that areavailable in Oracle Health Sciences Identity and Access Management Service forOracle Clinical One Platform and Oracle Clinical One Integration Hub grant rightsfor each product as a whole. They are not study-specific. An Oracle Clinical OnePlatform administrator must further assign study-specific rights to users from withinOracle Clinical One Platform.

Option 1. Ask users to navigate to your product URL and submit an accessrequestIf you activated approval for a role and published the role, users can request accessthemselves.


3-7

1. All Oracle Clinical One Platform users must perform these steps:

a. Navigate to the Oracle Clinical One Platform product URL.

b. Sign in with their single sign-on user name, type a justification, and submit it.An access request is created for the ClinicalOne_Production orclinicalone-CNE role.

2. All Oracle Clinical One Integration Hub users must perform these steps:

a. Navigate to each of the following product URLs, one at a time:

• Oracle Clinical One Platform product URL

• Oracle Clinical One Integration Hub URL with the following format:<org>-clinicaloneinthub.oracleindustry.com

• Oracle Clinical One Integration Hub URL with the following format:<org>-inthub.oracleindustry.com

b. For each URL, sign in with their single sign-on user name, type a justification,and submit it.Access requests are created for the following roles (respectively):




• clinicalone-CNE

• inthub-CNE

Note:

Users can't request the administration role (AssignGlobalRoles), which isrequired if users are responsible for creating studies and global users inOracle Clinical One Platform; or if they are training administrators, whocreate training managers users in Oracle Clinical One Platform. For thisrole, you must do one of the following:

• Assign this role to users individually. Keep reading for instructions.

• Assign this role using a bulk import. See Perform user operations inbulk.

Option 2. Assign roles to users yourselfShow me how!

1. Open Oracle Health Sciences Identity and Access Management Service:https://<ShortOrgId>-hs-identity.oracleindustry.com/identity

where <ShortOrgId> is the short name for your organization. This value is definedwhen your organization is added to Oracle Health Sciences Identity and AccessManagement Service.

2. Under Administration, click Users.


3-8


3. Enter search criteria for the user. For example:

• From the E-mail drop-down, select Equals, and type the user's emailaddress.or

• From the Display Name drop-down, select Equals, and type the user'sdisplay name.

4. Click Search, located below the filtering fields and to the right.

5. In the Search Results table, find the user, and in the User Login column, click theuser's name.

6. On the User Details page, select the Roles tab.

7. From the Actions drop-down, located above the table of roles, select Request.

8. Use the following questions to determine the roles that the user needs:

• Oracle Clinical One Platform users at organizations that use OracleClinical One Platform to create clinical studiesAssign the ClinicalOne_Production or clinicalone-CNE role to everyonewho needs to work in Oracle Clinical One Platform.

Note:

Some organizations use Oracle Clinical One Platform both to createclinical studies and to create training studies. If your organizationuses Oracle Clinical One Platform for both purposes, all users stillneed the ClinicalOne_Production or clinicalone-CNE role.

• Oracle Clinical One Platform users at organizations that use OracleClinical One Platform to create training studiesIf the user is responsible for creating studies and global users in OracleClinical One Platform; or if the user is a training administrator, who createstraining managers users in Oracle Clinical One Platform, you must assign thefollowing roles:


– ClinicalOne_Production_AssignGlobalRoles or clinicalone-CNE_AssignGlobalRolesClinicalOne_Production_AssignGlobalRoles and clinicalone-CNE_AssignGlobalRoles are role names; you might also see theirDisplay Name, AssignGlobalRoles, in Oracle Health Sciences Identityand Access Management Service.


3-9

Tip:


• Oracle Clinical One Integration Hub usersIn Oracle Health IAM, you will only see the roles thatcorrespond to the environment that you're provisioned in. Forexample, you either see clinicalone-CNE and inthub-CNE roles,or you see ClinicalOne_Production, IntegrationHub_Production andIntegrationHub_UI_Production roles. Choose the set of roles that appear inyour Oracle Health IAM application. If you encounter any issues in selectingroles, reach out to Health Sciences Support.

If the user is responsible for creating and configuring integrations managedthrough Oracle Clinical One Integration Hub, you must assign the followingroles:



– IntegrationHub_UI_Production

– clinicalone-CNE

– inthub-CNE

9. You've determined the roles the user needs; now it's time to find them and assignthem:

a. In the search box, type the name of the role and press Enter.

b. To the right of the role, click Add to Cart.

c. Add any additional roles the user requires.

10. In the upper-right, click Checkout.

11. Review the roles in the cart.

12. In the upper-right, click Submit .The Request Summary page opens, and a confirmation message appears at thetop of the page.

13. (If your organization has activated approval for the requested role) Ask someonewith the Approver role to approve the access requests so that the userreceives the role(s) you assigned. You cannot approve your own requests,so someone else at your organization with the Approver role must approvethem.

Step 3. Review and approve an access requestWant to understand how this task fits in the overall workflow for adding users?



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• Who does this? Anyone with the Approver role in Oracle Health Sciences Identityand Access Management Service, but keep in mind that you can't approve arequest that you requested for yourself or someone else.

• When do I do this? After another delegated administrator assigns roles to a user.

• Do I have to do this? If you activated approval for a role and published therole, yes, or users will never get access to the product. Access requests aregenerated 2 ways:

– When users (both from within Oracle and your own organization) navigate toyour product URL and submit an access request.

– When any administrator at your organization assigns a Clinical One role fromwithin Oracle Health Sciences Identity and Access Management Service.

• Check your pending approvals in Oracle Health Sciences Identity and AccessManagement Service frequently to see whether any new requests have come in. Anumber next to Pending Approvals in the menu on the left indicates the number ofopen access requests.

For instructions, see Approve or reject access requests.

Need to know the roles that everyone needs? See Assign roles to users.

Tip:

For ease of use, consider creating a custom view. For instructions, seeCustomize columns on the Approval Details page.

Step 4. Notify the administrator that they can start working in OracleClinical One Platform




• When do I do this? After the access request has been approved.

• Do I have to do this? It's a good idea so the user knows they can sign in and startworking.

• Notify the user(s) who were assignedthe ClinicalOne_Production_AssignGlobalRoles or clinicalone-CNE_AssignGlobalRoles role and let them know that they can start adding usersin Oracle Clinical One Platform.

The person with this role might be you! If so, keep reading to figure out your nextsteps in Oracle Clinical One Platform.


3-11

4Create global users

• Create a global user

Create a global userWant to understand how this task fits in the overall workflow for adding users?


• Who does this? A user who was assignedthe ClinicalOne_Production_AssignGlobalRoles or clinicalone-CNE_AssignGlobalRoles role in Oracle Health Sciences Identity and AccessManagement Service.

• Anything I have to do first? An administrator must create a single sign-onaccount and assign the appropriate roles for the global user (both activities aredone in Oracle Health Sciences Identity and Access Management Service).

• Which users need to be global users? Typically, an organization has a limitednumber of global users. If a user performs one of the following tasks, they must beadded as a global user:

– Add the first user to each study. (The user can add more than 1! But you haveto be a global user to add the first user.)

– Set up integrations.

– Act as a training manager or training administrator for managing training inother Oracle Health Sciences products.

Don't forget to add yourself as a global user!

• Do I have to do this? Yes, every organization needs at least one global user whocan create at least the first user in each study.

Show me how!

1. On the Home page, click Global Settings, along the top.

2. Click Create Global User.

3. From the Full Name drop-down, select the user's name.

4. Click into the Global Roles field and select one or more global roles to assign tothe user across all studies in Clinical One.

4-1


Responsibility Role to assign Notes

• Create studies• Manage global users• Add users to a study

and assign all roles,including study designroles

Study Creator The only people who cangive access to people whoare responsible for studydesign are global users withthe Study Creator role.

Tip:

If the user isresponsible forassigning otherusers to sites, theuser must also bea site and usermanager, and beassigned to allsites and depotsthat they have toassociate userswith. See Learn:Typical role,site and depotassignments formore information.

• Manage global users• Add users to a study

and assign all roles,including study designroles

• Turn off the trainingrequirement for yourorganization

Global User Manager

Tip:

If the user isresponsible forassigning otherusers to sites, theuser must also bea site and usermanager and beassigned to allsites and depotsthat they have toassociate userswith. See Learn:Typical role,site and depotassignments formore information.

Chapter 4Create a global user

4-2


• Integrate Oracle ClinicalOne Platform withanother applicationusing Oracle ClinicalOne Integration Hub

Integration Manager This role includes thecomplete set of permissionsfor Oracle Clinical OneIntegration Hub and allowsthe user to:

• Access Oracle ClinicalOne Integration Hub

• Use all of its featuresto create, configure,update, monitor, andtroubleshoot nativeintegrations andintegrations built throughthe integration builder

• Make calls to the OracleClinical One IntegrationHub APIs

Tip:

Error messagesmay revealintegration datathat canpotentially beunblinding. Theusers who reviewerror messagesshould not beblinded membersof the study team.

• Create and managenew integration typesbetween Oracle ClinicalOne Platform and otherapplications using theintegration builder inOracle Clinical OneIntegration Hub

Integration Builder This role is assignedalong with the IntegrationManager role, to let userssign in Oracle Clinical OneIntegration Hub.The Integration Builder roleallows the user to createand manage new integrationtypes using the integrationbuilder functionality.


4-3


• View integrations andsettings in IntegrationHub

Integration Viewer This is a view-only rolefor Oracle Clinical OneIntegration Hub and allowsthe user to:

• Access Oracle ClinicalOne Integration Hub

• View all existingintegrations andsettings, includingcurrent status or setup

• Download integrationfile templates andintegration files forexisting integrationsUsers with this rolecan't make anychanges in OracleClinical One IntegrationHub, meaning thatthey can't managesettings, integrations, orintegration jobs.

• Create training studiesfor and assign trainingmanagers to trainingstudies for the followingproducts:– Oracle InForm– Oracle Central

Designer– Oracle Central

Coding– Oracle User

Management Tool– Oracle IRT

Training Administrator You need to assign thisrole to users only if you'reusing HS Learn - Manager tocreate training studies for thefollowing products:

• Oracle InForm• Oracle Central Designer• Oracle Central Coding• Oracle User

Management Tool• Oracle IRT

• Assign training to usersand send reminders forthe following products:– Oracle InForm– Oracle Central

Designer– Oracle Central

Coding– Oracle User

Management Tool– Oracle IRT

• Check the training that auser has completed andrun reports for assignedand completed training.

Training Manager You need to assign thisrole to users only if you'reusing HS Learn - Manager tocreate training studies for thefollowing products:

• Oracle InForm• Oracle Central Designer• Oracle Central Coding• Oracle User

Management Tool• Oracle IRT


4-4

Tip:

To view the permissions for a role, click View Permissions, and selectthe role from the Roles drop-down.

5. Click Create.

6. Contact the global users for your organization and ask them to create the studyand the site and user manager for the study. See Learn: Typical role, site anddepot assignments for more information.


4-5

5Add a user to a study



• Who does this? You must be a site and user manager for the study (see Site anduser managers). If you need to make the user a site and user manager, you mustalso be a global user with either the Global User Manager or Study Creator role.

• Anything I have to do first? An administrator must create a single sign-onaccount and assign the appropriate roles for the users you're (both activities aredone in Oracle Health Sciences Identity and Access Management Service).

• If a user already has a single sign-on account with roles, why do I need toassign more roles? You need to give users the appropriate study-level roles sothey can see the study on their Home page and work in it.

Show me how!

1. On the Home page, click the study settings button ( ) on the study you want toedit, and select Open Settings.

2. Below the study name, click the Users tab.

3. Click Create User.

4. Fill in the fields on the first page in the wizard, and click Next. To view tips forcompleting a field, click into the field or choose an option.

• Name and email (Full Name, User Name, Email)

• Effective Date Range: Specify when the user has access to the study. Toallow the user's access to continue without expiring, select No End Date. Afteryou finish provisioning the user in the study, the user receives an email withthe name of the study, the URL for Clinical One, and the date when they canstart working.

• Production, Testing, and Training Roles: Choose the appropriate roles foreach mode that the user will work in:

– To assign the right roles for the right modes, see Learn: Typical role, siteand depot assignments.

– To better understand roles and their permissions, see Learn: Descriptionsof each role.

– To choose the right roles required for reports and notifications the userneeds, see Report descriptions and the roles that can run them andNotification descriptions and the roles that receive them.

5. On the second page of the wizard, select the sites and depots for the useraccording to their roles. To assign them to the right sites and depots, see Learn:Typical role, site and depot assignmentsYou can assign a site to a user only if youare already assigned to the site.

6. After you complete the wizard, click Close.

5-1


https://docs.oracle.com/health-sciences/clinical-one/sponsor-cro-information/217353.htm

https://docs.oracle.com/health-sciences/clinical-one/sponsor-cro-information/217354.htm

Tips:

• Users at your organization should take training that is relevant to theirassigned roles in Oracle Clinical One Platform before starting to work inthe application. Your organization should implement mechanisms to addressregulatory requirements concerning training.

• To see the roles and sites assigned to a user, select the user, and expand Rolesand Sites on the right.

• Learn: Typical role, site and depot assignments

Learn: Typical role, site and depot assignmentsSite and user managers

Which users need to be site and user managers? Anyone who needs to add otherusers to the study and assign the user to individual sites and depots.

My organization has global users. Do we need site and user managers, too? Yes.A global user can create users in any study but can't assign them to individual sitesand depots. Only a site and user manager for a specific study can assign users toindividual sites and depots.

Note:

A site and user manager might have other roles, too. For instance, a usercan be a clinical research associate and a site and user manager.

Here's a list of the typical role, site and depots assignments for site and usermanagers:

Table 5-1 Role, site and depot assignments for site and user managers

Job Typical roleassignment

Typical siteassignment

Typical depotassignment

Site and usermanager

For Study DesignRoles choose theUser Manager role.

For Production,Testing and Trainingchoose the SiteManager role.

Select the checkboxesto assign the user toall the sites that theuser must assign otherusers to. For instance,if the site and usermust assign users toSite A, the site anduser manager mustalso be assigned toSite A.

Select the checkboxesto assign the user toall the depots that theuser must assign otherusers to.

Study team members

Which users can be study team members? Typically, study team members work ata sponsor or CRO level and perform tasks during the study design and study conductperiods.

Chapter 5Learn: Typical role, site and depot assignments

5-2

Here's a list of the typical role, site and depots assignments for study teammembers:

Table 5-2 Role, site and depot assignments for study team members




Clinical supplymanager

For Production,Testing, and Trainingroles choose:• Clinical Supply

Manager• Randomization

List Manager• Subject

TransferredNotification

• View StudyDesign

Choose All Sites. Choose All Depots.

Randomization listmanager

For Production,Testing, and Trainingroles choose:• Randomization

List Manager• View Study

Design

Choose All Sites. Choose All Depots.


5-3

Table 5-2 (Cont.) Role, site and depot assignments for study team members




Study designer For Study DesignRoles choose:• Unblinded

Designer, if theuser designsrandomization,including creatingtreatment arms.

• Designer, ifthe userdoesn't designrandomization.

For Productionand Training Roleschoose:• Import Design• Study Manager• View Study

Design• Production

Admin, if thestudy designer isalso responsiblefor setting upthe connection toOracle mHealthConnector

• Rule Publisher

For Testing Roleschoose:• Import Design• Study Manager• View Study

Design• Clinical Supply

Manager• Randomization

List Manager• Site User, Site

Inventory User,and Code Break,if the user willverify the study.

• ProductionAdmin, if thestudy designer isalso responsiblefor setting upthe connection toOracle mHealthConnector

• Rule Designer

• Assign noProduction orTraining sites

• Select All TestingSites

Assign no depots


5-4





• Rule Tester

Study manager For Production,Testing, and TrainingRoles choose:• Study Manager• Subject Transfer

or SubjectTransferredNotification

• Import Design• View Study

Design• Site User, Site

Inventory User,and Code Break

• Sponsor QueryManager

Select All Sites Assign no depots

Clinical researchassociate (CRA)

For Production andTraining Roles:• CRA• Subject Transfer• Subject

Notificationsor SubjectTransferredNotification


For Testing Roles:• Site User• Site Inventory

User• Code Break• Subject Transfer• Subject

Notificationsor SubjectTransferredNotification


If the user isresponsible for sitemanagement, selectAll Production Sitesand All TrainingSites.Otherwise, select onlythe Production andTraining sites that theuser manages andany Testing sites thatthe user will work in.

Assign no depots.

Data manager For Production,Testing, and TrainingRoles choose:• Data Manager• Sponsor Query

Manager

Select All ProductionSites and All TrainingSites.

Assign no depots.


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Safety monitor For Production,Testing, and TrainingRoles choose:• Code View

• Select AllProduction Sitesand All TrainingSites.

• Select any Testingsites that the userwill work in.

Assign no depots.

Productionadministration

For Study DesignRoles choose noroles.

For Production,Testing, and TrainingRoles choose:• Production Admin

• Select AllProduction Sitesand All TrainingSites.

• Select any Testingsites that the userwill work in.

Assign no depots.

Site and depot users

Which users need to be site and depot users? Anyone who needs to work at a siteor depot during the study conduct period.


5-6

Table 5-3 Role, site and depot assignments for site and depot users




Site user For Study DesignRoles choose noroles.

For Testing Roleschoose no roles.

For Productionand TrainingRoles choose theappropriate rolesfor the user'sresponsibilities:• Site User• Site Inventory

User• Code Break• Lead Site User• Site User with

Detailed DosingView

• ShipmentNotification

• SubjectNotificationsor SubjectTransferredNotification

• Site Query User

• Select only theProduction andTraining sites thatthe user works at

• Select Testingsites only if theuser is involved inthe verification ofthe study

Assign no depots

Depot user For Study DesignRoles choose noroles.

For Testing Roleschoose no roles,unless the useris involved in theverification of thestudy

For Productionand Training Roleschoose:• Unblinded Depot

User

• Select only theProduction andTraining sites thatthe user's depotships to

• Select no Testingsites, unless theuser is involved inthe verification ofthe study

• Select only theProduction andTraining depotsthat the userworks at

• Select no Testingdepots, unless theuser is involved inthe verification ofthe study


5-7

6Learn: Descriptions of each role

• Site user roles

• Study team: Study design roles

• Study team users: Blinded roles

• Study team users: Unblinding roles

• Oracle employee roles

Site user rolesAbout these roles

• Modes: Testing, Training, and Production

• Users: Site users, and sponsor or CRO users as needed (typically only forvalidation purposes in Testing mode)

• Type: Roles are both blinded and unblinding. Unblinding roles allow users to viewtreatment arm details. Unblinding roles are identified.

Want to know which role to assign to each user? See the list for site users at Learn:Typical role, site and depot assignments

6-1

Most site users have one or more of the following roles

Table 6-1 Site user roles

Role Available tasks include

Lead Site User This role allows site users to seeunblinding information.This role combines the Site User, SiteInventory User, and Code Break roles.• Dispense kits without calculated doses• Dispense kit type titrations and perform

dose changes for subjects• Dispense IoT-enabled devices managed

with Oracle mHealth Connector• Activate, deactivate, and replace

dispensed IoT-enabled devices managedwith Oracle mHealth Connector

• Edit form data for subjects• Edit visit dates• Sign data at a subject level for sites

they're assigned to• Randomize subjects• Receive notifications:

– Code Break– Training

• Run reports:– Kit Reconciliation report– Subject Data report– Subject Dispensation report– Subject Events report– Training report– User Assignment by Site report– User Assignment report

• Customize the Subject Events report• Skip visits• View blinded dispensation details without

calculated doses• View form data for subjects• View shipments to sites• View site inventory

Chapter 6Site user roles

6-2

Table 6-1 (Cont.) Site user roles


Site User • Dispense kits without calculated doses• Dispense kit type titrations and perform




• Edit form data for subjects• Randomize subjects• Run reports:

– Subject Data report– Subject Dispensation report– Subject Events report

• Customize the Subject Events report• Generate the Oracle CRF Submit archive

called Archival PDF• Receive notifications:

– Shipment for destruction not received– Kit missing from shipment for

destruction– New shipment for destruction created

• View blinded dispensation details withoutcalculated doses

• View form data for subjects

Site Inventory User • Receive notification of new shipments• Receive shipments and update site

inventory• Run reports:

– Blinded Inventory report– Subject Dispensation report– Shipment Order Summary

• View shipments to sites• View site inventory

Some site users additionally have one or more of the following roles

Table 6-2 Site user roles


Code Break This role allows site users to seeunblinding information.• Edit form data for subjects• Run reports:

– Subject Data report– Subject Events report

• Unblind subjects' treatment arms (do acode break)



6-3

Table 6-2 (Cont.) Site user roles


Site Query User • Answer queries• Dispense kits without calculated doses• Edit form data for subjects• Randomize subjects• Run reports:

– Subject Data report– Subject Events report– Subject Queries report

• View form data for subjects• View queries

Site User with Detailed Dosing View This role allows site users, typicallypharmacists, to see potentially unblindinginformation when they view dosinginformation.• Dispense kits with calculated doses• Dispense kits without calculated doses• Dispense kit type titrations and perform




• Edit form data for subjects• Randomize subjects• Run reports:

– Subject Data report– Subject Dispensation report– Subject Events report

• View blinded dispensation details withoutcalculated doses

• Receive notifications about dispensationfailures and completed dispensation withdosing instructions


View Unblinded Pharmacist kits in a study This role is typically assigned to apharmacist or an unblinded site user.Assign this role along with the Site User orLead Site User role for users to view anddispense Unblinded Pharmacist kits in thesystem. You can assign this role to any otherusers who should view or monitor UnblindedPharmacist kits in the system, such as theClinical Research Associate (CRA).

• Dispense Unblinded Pharmacist kits• Receive Unblinded Pharmacist

dispensation notification• Run the Subject Dispensation report to

view Unblinded Pharmacist kits• Monitor Unblinded Pharmacist kits in the

site and study inventory


6-4

Study team: Study design rolesAbout these roles

• Modes: None, available for study design

• Users: Sponsor or CRO users

• Type: Both blinded and unblinding

Want to know which ones to assign to each user? See the lists for site anduser managers and study team members at Learn: Typical role, site and depotassignments.

Most study design team members have one or more of the following roles

Table 6-3 Study design roles


Designer This role is typically assigned to studydesigners who, unlike Unblinded Designers, donot create randomization designs.

• Design forms• Design visits and events• Edit study settings on the General tab• Run the Study Design Report• Run the Rules report• View the study design (when the study

design is below Draft on the Home page)

Integration Designer Reserved for a future release.

Unblinded Designer This role is typically assigned to studydesigners who are responsible for creatingrandomization designs.

• Design forms• Design randomization• Design supplies and dispensation

(including kit type tritrations and IoT-enabled devices managed with OraclemHealth Connector)

• Design visits and events• Edit study settings on the General tab• Run the Study Design report• Edit code lists• Delete code lists• View the study design (when the study

design is below Draft on the Home page)

Chapter 6Study team: Study design roles

6-5

Table 6-3 (Cont.) Study design roles


Rule Designer This role is typically assigned to studydesigners who are responsible for creating andediting rules.• Create a rule• Edit a rule with a status of Draft• Update a rule's status from Draft to UAT• Update a rule's status from UAT to Draft• Enable or disable a rule with a status of

Draft, UAT or Approved while the rule isrunning in Testing mode

• View a rule with a status of Draft, UAT,Approved or Published

• Edit a rule with a status of Published inTesting mode

• Edit a rule that's published in a live study• Delete a rule with a status of Draft, UAT or

Approved• Run the Rules report

Rule Tester This role is typically assigned to studydesigners who are responsible for testing arule in its various states.• View a rule with a status of Draft, UAT,

Approved or Published• Update a rule's status from UAT to

Approved• Update a rule's status from Approved to

UAT• Update a rule's status from Published to

Draft• Enable or disable rules with a status of

Draft, UAT, Approved or Published• Run the Rules report

Rule Publisher This role is typically assigned to studydesigners who are responsible for publishingrules to Production.• View a rule with a status of Draft, UAT,

Approved or Published• Enable or disable a rule with a status of

Published while they're running in a livestudy

• Update a rule's status from Approved toPublished

• Update a rule's status from Published toDraft

• Move the study from the Testing to theProduction container to publish multiplerules in Production

• Re-run Rules• Run the Rules report• Receive the Rule Re-run Notification

Chapter 6Study team: Study design roles

6-6

Table 6-3 (Cont.) Study design roles


User Manager This role, along with the Site Manager role,is frequently assigned to users who areresponsible for managing sites and users.

• Add and administer study users• Run reports:

– Training report– User Assignment by Site report– User Assignment report

• View sites• View depots• View role assignments for study users

View Design This role has been replaced by View StudyDesign.

Study team users: Blinded rolesAbout these roles

Just want to know which ones to assign to each user? See the lists for site anduser managers and study team members at Learn: Typical role, site and depotassignments.


• Users: Sponsor and CRO users

• Type: All roles are blinded

Chapter 6Study team users: Blinded roles

6-7

Most blinded study team users have one or more of the following roles

Table 6-4 Study team roles


CRA Assign this role along with the ViewUnblinded Pharmacist Kits in the studyrole, to create an Unblinded CRA rolethat can monitor and review UnblindedPharmacist kits.• Create shipments to a drug destruction

facility• Perform source data verification (SDV)• Update the status of inventory• Perform supplies reconciliation at a site• Run reports:

– Blinded Inventory report– Enrollment report– Kit Reconciliation report– Subject Data report– Subject Events report– Subject Queries report– Training report– Subject Visit Schedule report– Titration Summary report– Shipment Order Summary report

• Generate Oracle CRF Submit archivesand reports:– Archival PDF– Submission PDF– Download Log– Blank Form PDF

• Customize the Subject Events report• Receive notifications:

– Shipment for destruction not received– Kit missing from shipment for

destruction– New shipment for destruction created

• View form data for subjects• View shipments to sites• View site inventory• View sites• View depots• View regions• View subject settings


6-8

Table 6-4 (Cont.) Study team roles


Data Manager • Run reports:– Subject Data report– Subject Events report– Subject Queries report

• Run the Subject Data Extract (Unblinded)• Customize the Subject Events report• Generate Oracle CRF Submit archives

and reports:– Archival PDF– Submission PDF– Download Log– Blank Form PDF

• View form data for subjects• View subject settings• View supply settings, blinded groups, label

groups, and resupply strategies

Site Manager This role, along with the User Manager role,is frequently assigned to users who areresponsible for managing sites and users.

• Assign a resupply strategy to a site• Assign a study version to a site• Create and manage depots• Create and manage sites• Receive a notification when a site has

been updated• Run the site and depot report• View sites• View depots

Study Manager • Edit regions• Edit subject settings• Run reports:

– Enrollment report– Site and Depot report– Subject Data report– Subject Dispensation report– Subject Events report– Subject Queries report– Training report– Subject Visit Schedule report– Titration Summary report

• Customize the Subject Events report• Generate Oracle CRF Submit archives

and reports:– Archival PDF– Submission PDF– Download Log– Blank Form PDF


6-9

Some blinded study team users additionally have one or more of the followingroles

Note:

Some members of the study team require site roles, typically only in Testingmode so they can validate the study.



Import Design The mode where this role is assigned matters.Granting this role for Testing mode lets usersmove the Draft version of the study toTesting; granting this role for both Training andProduction lets users move the Testing versionto Approved.

• Assign a resupply strategy to a site• Assign a study version to a site• Move a study design to Testing or

Production on the Home page• View sites• View a study design

Shipment Notification • Receive a notification when a newshipment is requested or created

Sponsor Query Manager • Close queries• Create candidate queries• Create queries• Delete queries• Run the Subject Queries report• View form data for subjects

Study Design Report • Run the Study Design report• View study design• View depots• View regions• View subject settings• View supply settings, blinded groups, label


Subject Notifications • Receive the code break notification• Receive the subject withdrawal notification• Receive the subject transferred

notification• Receive the blinded randomization

notification• Receive the blinded dispensation

notification

Subject Transferred Notification If the user needs additional subject-relatednotifications, consider assigning SubjectNotifications instead.

• Receive the subject transferrednotification


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Transfer Subjects • Receive the subject transferrednotification

• Transfer subjects between sites• View form data for subjects• View sites

View Study Design This role is required if users with theClinical Supply Manager or RandomizationList Manager roles need to work withrandomization or kit lists.

• View the study design

Study team users: Unblinding rolesAbout these roles

Just want to know which ones to assign to each user? See the lists for site and usermanagers, study team members, and site and depot users at Learn: Typical role, siteand depot assignments.



• Type: All roles are unblinding

Chapter 6Study team users: Unblinding roles

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Most unblinded study team users have one or more of the following roles



Clinical Supply Manager • Assign a resupply strategy to a site• Assign a study version to a site• Create and manage depots• Create and manage lots• Create and manage sites• Edit regions• Edit supply settings, blinded groups, label

groups, and resupply strategies• Manage study inventory (with an

unblinded view of inventory)• Receive notifications:

– For new shipments– For cancelled shipments– For updated sites– For training– For completed blinded randomization

visits– For completed unblinded

dispensation visits– For dispensation visits that failed to

complete– View and update a kit's barcode– Manage site inventory (with a blinded

view of the inventory)• Run reports:

– Blinded Inventory report– Enrollment report– Kit Reconciliation report– Site and Depot report– Subject Dispensation report– Unblinded Chain of Custody report– Unblinded Inventory report– Subject Visit Schedule report– Titration Summary report– Shipment Order Summary report

• Upload and generate inventory lists• View form data for subjects• View shipments to sites• View site inventory• View sites• Update inventory lists• View depots• View regions• View subject settings• View supply settings, blinded groups, label

groups, and resupply strategiesKeep in mind:


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• Users must have the Randomization ListManager role to work with randomizationlists.

• Users must also be granted View StudyDesign to work with randomization and kitlists.

Code View • Edit form data for subjects• Reveal a subject's treatment arm (do a

code view)• Run reports:

– Subject Data report– Subject Events report


Randomization List Manager Users must also be granted View StudyDesign to work with lists.

• Edit regions• Manage randomization lists• Run reports:

– Study Design report– Unblinded Randomization report

• Receive notifications for randomizationvisits that failed to complete

• Receive notifications for completedunblinded randomization visits

• Upload and generate randomization lists• View form data for subjects• View sites• View study design• View regions• View subject settings

Unblinded Depot User • Receive notifications– New shipments– Cancelled shipments– Site has been updated

• View shipments to sites• View site inventory• Manage study inventory with an unblinded

view of inventory• Receive and destroy shipments• Update inventory listsKeep in mind:• If a user has the Unblinded Depot User

role, the user has only an unblinded viewof inventory, and the unblinded view isdifferent from a blinded view of inventory.If the user needs the blinded view ofinventory, you must remove the UnblindedDepot User role for the user.


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Oracle employee rolesAbout these roles

Just want to know which ones to assign to each user? See the list for Oracleemployees at Learn: Typical role, site and depot assignments.



• Type: All roles are unblinding

Oracle users typically have one or more of the following roles

Table 6-7 Oracle roles


Production Admin This role is for members of the SaaS Servicesteam so they can help your organization asneeded.

• Assign a resupply strategy to a site• Assign a study version to a site• Edit subject and device settings• Edit supply settings, blinded groups, label

groups, and resupply strategies• Upload and generate inventory lists• Upload and generate randomization lists• View sites• View study design• View depots• View regions• View subject settings• View supply settings, blinded groups, label


Chapter 6Oracle employee roles

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Table 6-7 (Cont.) Oracle roles


View Only - Support This role is for members of Health SciencesSupport and allows Oracle users to viewdetails about a study to assist withtroubleshooting as needed.

• Run reports:– Blinded Inventory report– Enrollment report– Kit Reconciliation report– Rules report– Site and Depot report– Shipment Order Summary report– Study Design report– Subject Data report– Subject Dispensation report– Subject Events report– Subject Queries report– Training report– Unblinded Chain of Custody report– Unblinded Inventory report– Unblinded Randomization report– User Assignment by Site report– User Assignment report

• Customize the Subject Events report• View form data for subjects• View only - Support• View shipments to sites

Chapter 6Oracle employee roles

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7Learn: Frequently asked questions (FAQs)

• Can I update a user's account after creating it?

• Do I need to revoke access for SaaS Services users after collaboration iscomplete?

• Do I need to revoke access for Health Sciences Support users after a ticket isresolved?

• How do I control users' access to the application?

• What happens if I change the roles that a user is assigned to while the user islogged in?

Can I update a user's account after creating it?Yes. For information and instructions, see Update user accounts.

Do I need to revoke access for SaaS Services users aftercollaboration is complete?

SaaS Services users need to retain access rights for your instance of Oracle ClinicalOne Platform throughout its existence, so you should not revoke the access roles fromthese users. After a project has ended, the accounts of all Oracle users involved areset to expire in Oracle Clinical One Platform within 60 days, at which point they loseaccess to data in Oracle Clinical One Platform.

Do I need to revoke access for Health Sciences Supportusers after a ticket is resolved?

You can, but you don't have to. Health Sciences Support user accounts have accessin Oracle Clinical One Platform for only two weeks. After two weeks, access eitherexpires or, if the issue is not yet resolved, they can extend the period by another week,after which access expires.

How do I control users' access to the application?You assign users to roles. You can't change the permissions that are associated witheach role, but roles are granular and allow you to control a user's access to OracleClinical One Platform, including access to reports and notifications.

Additionally, you can assign a user to different roles in each mode. For instance, astudy designer might be able to screen and randomize in Testing mode but cannot dothe same activities in Production mode.

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What happens if I change the roles that a user is assignedto while the user is logged in?

The user's view of the application updates within 15 minutes. After you save the rolechanges, the user can no longer open an object or change it if you removed the user'spermissions to view or edit the object, even before the user's view updates.

Chapter 7What happens if I change the roles that a user is assigned to while the user is logged in?

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