Granting Data Access to RDC Users

In this section:

• Granting Automatic Access in RDC to Studies Granted in Oracle Clinical
  
• Configuring Study and Site Security Privileges
  
• Changing the Default Access to DCIs
  

Granting Automatic Access in RDC to Studies Granted in Oracle Clinical

You can use a reference codelist setting to determine whether users who have access to data for a particular study in Oracle Clinical automatically have access to the study in RDC.

In the OCL_STATE local reference codelist, set the DMGR RDC ACCESS short value as follows:

• When set to YES, a user with no study privileges defined for RDC but with study access defined in Oracle Clinical is automatically given RDC Onsite access to the study as well, in both Test and Production modes. The user has all RDC privileges except APPROVE and VERIFY. UPD_LOCK_OC, an Oracle Clinical-specific privilege, is also excluded. You can restrict such a user's access to RDC Onsite by limiting privileges at the study or site level; see the Oracle Clinical Remote Data Capture Onsite Administrator's Guide for more information.

• When set to NO, a user granted access to a study in Oracle Clinical does not automatically have access to that study in RDC Onsite. You can use the Study Security form to assign specific privileges to the user; see the Oracle Clinical Remote Data Capture Onsite Administrator's Guide for more information.

Users with the Super User? flag selected in the Oracle Accounts form in Oracle Clinical have access to all studies in both Oracle Clinical and RDC, and in both Test and Production modes.

Configuring Study and Site Security Privileges

You can give RDC users specific privileges for particular studies and sites in the Study and Site Security windows, which are included in both Oracle Clinical and in the RDC Onsite Administrator's Tool; see also "Configuring Discrepancy Management in Oracle Clinical Remote Data Capture Onsite Administrator's Guide.

Changing the Default Access to DCIs

RDC Onsite includes a predefined set of user roles. By default, these roles have UNRESTRICTED access to all DCIs (Data Collection Instruments, which become CRFs). You can change the default access for any role to RESTRICTED, then further define which DCIs (within the user's study/site access) can be accessed by that user's role.

• Users assigned to a role with UNRESTRICTED access to DCIs can access any DCI in RDC Onsite unless access has been denied to a particular DCI in a particular study through the DCI Access window in the Oracle Clinical Definition menu; see Oracle Clinical Creating a Study for study-level information.

• Users assigned to a role with RESTRICTED access to DCIs cannot access any DCIs in RDC Onsite unless access has been granted to a particular DCI in a particular study.

You may want to create custom database roles specifically for the purpose of restricting access to certain DCIs to smaller groups of people (see Creating Custom Database Roles for more information and an example). If you do, you must add the new role in the Maintain DCI Access by Role window and specify a default access of RESTRICTED or UNRESTRICTED for it.

Caution:

If you create a new user role but do not specify a default value for DCI access, users assigned to that role cannot log in to RDC Onsite. You must define the default access to DCIs for every user role you plan to assign.

If you assign a user to more than one role, and those roles have conflicting DCI access, the user cannot log it to RDC Onsite.

Before you can change the default DCI access for a user, the user role must exist (must be valid). You cannot change the default DCI access if the user role does not exist.

To define the DCI access for a user role:

1. Open Oracle Clinical.

2. Navigate to Admin and then select Users and Roles.

3. Select Default DCI Access by Role.

   Alternatively, you can select one of the following menu options depending upon your administrator privileges and current task:

   • Select Test Default DCI Access to try out DCI access before implementing the feature in a live study.

   • Select Query Default DCI Access by Role if you only want to view the current settings but make no changes.

4. Enter a valid user role in the User Role field. You can:

   • Type the name of a valid user role into the field.

   • Click the List of Values button, and then select a user role from the list. The list includes all the user roles currently defined in the installation reference codelist.

5. Enter the default DCI access for the selected user role. Valid entries are:

   • UNRESTRICTED — Allows study/site access to all DCIs unless otherwise restricted in the DCI Access form for the study.

   • RESTRICTED — Does not allow access to any DCIs unless you specify exceptions in the DCI Access form for the study.

   You can type a valid entry directly into the field. Alternatively, you can click the List of Values button, and then select from the list.

6. Continue to enter each user role and the type of DCI access allowed.

7. Save your changes.

For each record in the Maintain Default DCI Access by Role form, Oracle Clinical creates and maintain an audit trail.

Upon initial entry to the form, Oracle Clinical populates the form with all the user roles defined in the reference codelist. For each user role, the Default DCI Access field is set to UNRESTRICTED. You must add any new user roles that you create.