Security reference information

7 Security reference information

Application roles for specialized administrators

Give these roles to a few people.

Parent topic: Security reference information

DMW Adapter Security Admin

This role is intended for administrators who assign user groups to adapters to external systems such as InForm. It provides access to the Adapter Security page.

Parent topic: Application roles for specialized administrators

DMW Data Security Admin

This role is intended for administrators who create roles and user groups, and who assign users to roles within user groups. It provides access to the Security page.

Parent topic: Application roles for specialized administrators

DMW Checkin Admin

This role is intended for administrators who should be able to check in an object checked out by another user, for example, if the user leaves the company.

Parent topic: Application roles for specialized administrators

Application roles for user interface access

Each user must have at least one application role to access the DMW user interface. These roles apply across all studies.

Parent topic: Security reference information

DMW System Administrator

This role is intended for users who do administrative tasks including setting up data sources and defining objects used across studies, such as categories, flags, and tags. It provides access only to the Administration page. (Home page access may not be needed because the administrator does not work in studies. The Home page is where you select a study.)

Parent topic: Application roles for user interface access

DMW Study Manager

This role is intended for users who run data loads, transformations, and validation checks. It provides access to the Home, Study Configuration, and Data Management pages.

Parent topic: Application roles for user interface access

DMW Study Consumer

This role is intended for users who need to review data and create and manage discrepancies. It provides access to the Home and Data Management pages.

Parent topic: Application roles for user interface access

DMW Study Configurator

This role is intended for users who set up studies by defining models, transformations, and validation checks. It provides access to the Home, Study Configuration, and Data Management pages.

Note:

There is no functional difference between the application roles DMW_STUDY_MANAGER and DMW_STUDY_CONFIG.

Parent topic: Application roles for user interface access

DMW Library Administrator

This role is intended for users who create and modify library models and codelists. It provides access only to the Library page.

Parent topic: Application roles for user interface access

DMW Database User

This role allows users to log in to the DMW database through a visualization tool to view data in a data model business area. If you assign this role to a user, be sure to also click the link to send an email to the user with their database account name.

Parent topic: Application roles for user interface access

Data Blinding-related application roles

Some DMW users should have blinding-related privileges in order to view blinded data or to unblind data. This requires both an application role, which applies to the user in any study, and a blinding-related object security privilege through a role in a user group assigned to a particular study or object in a study.

Since the most commonly used predefined object security roles include object-level access to blinded data and the ability to unblind data, it is very important that you assign these application roles only to users who require them.

Parent topic: Security reference information

DMW Data Blind Break User (Dev, QC, and Prod)

Users with this role can do the following in the corresponding lifecycle stage, if they belong to a user group assigned to the object and in that group have a role with the blinding-related object security privilege noted:

Run a program that reads from currently blinded tables and operates on the real data, not the masked or dummy data (also requires an object security role with the Blind Break operation on Table instances).
View currently blinded data in the user interface (also requires an object security role with the Blind Break operation on Table instances).
View currently blinded data through a visualization tool (requires an object security role with the Blind Break operation on Table instances).

Parent topic: Data Blinding-related application roles

DMW Data Unblind User (Dev, QC, and Prod)

Users with this application role can do the following in the corresponding lifecycle stage, if they belong to a user group assigned to the object and in that group have a role with the blinding-related object security privilege noted:

Unblind data in Table instances (also requires an object security role with the Unblind operation on Table instances).
Reblind data in Table instances that was previously unblinded (also requires an object security role with the Unblind operation on Table instances).

Note:

The DMW Data Unblind User application role is not required in conjunction with the Read Unblind object security operation.

Parent topic: Data Blinding-related application roles

Predefined object security roles

The roles in this chapter are sample roles provided for illustrative purposes only and are not intended to be used for production needs.

Each role includes all blinding-related privileges. However, in order to perform blinding-related operations users must have blinding-related application roles as well; see Data Blinding-related application roles.

Parent topic: Security reference information

Oracle DMW_STUDY_DEVELOPER

The Oracle DMW_STUDY_DEVELOPER object security role is intended for users who configure studies by creating data models and creating and running transformations and validation checks. To test their work, they also need to be able to load data into the development lifecycle area from InForm and files, create custom listings, create and act on discrepancies, assign flags to records, and promote objects from Development to QC and Production. Blinding-related privileges are also included in this role.

Users with this role should have the Oracle DMW_STUDY_MANAGER or Oracle DMW_STUDY_CONFIG application role. If they need to create library data models they should also have the Oracle DMW_LIB_ADMIN application role.

Oracle DMW_STUDY_DEVELOPER allows users to perform the following operations on the specified objects.

Parent topic: Predefined object security roles

Clinical Data Models and Query Builder

Users assigned the Oracle DMW_STUDY_DEVELOPER role have access to the following operations for clinical data models and the query builder.

Parent topic: Oracle DMW_STUDY_DEVELOPER

Oracle LSH Object Operations

Application Area: Create Work Area
Application Area: View
Domain: Create Data Model
Domain: Create Load Set
Domain: Create Variable
Domain: View
Load Set: View
Load Set: Modify
Load Set: Modify Val Status to QC
Load Set: Modify Val Status to PROD
Table: View
Table: Modify
Table Instance: Modify
Table Instance: Remove
Table Instance: Modify Val Status to QC
Table Instance: Modify Val Status to PROD
Variable: Modify
Variable: Modify Val Status to QC
Variable: Modify Val Status to PROD
Work Area: Create Table Instance
Work Area: Create Load Set Instance
Work Area: Modify
Work Area: Modify Val Status to QC
Work Area: Modify Val Status to PROD
Work Area: Delete
Work Area: Deploy (Install)
Work Area: View

Parent topic: Clinical Data Models and Query Builder

Oracle DMW Object Operations

Data Model: Modify
Data Model: Delete
Data Model: Publish Dev (used to install the Development Work Area)
Data Model: Modify Supporting Info
Data Model: Modify Val Status to QC
Data Model: Modify Val Status to PROD
Data Model: Create Private Listing
Data Model: Create Public Listing

Parent topic: Clinical Data Models and Query Builder

Blinding

Users assigned the Oracle DMW_STUDY_DEVELOPER role have access to the following operations for blinded data.

Oracle LSH Object Operations

Parent topic: Oracle DMW_STUDY_DEVELOPER

Oracle LSH Object Operations

Table Instance: ReadData
Table Instance: BlindBreak
Table Instance: Unblind
Table Instance: ReadUnblind

Parent topic: Blinding

Filters

Users assigned the Oracle DMW_STUDY_DEVELOPER role have access to the following operation for filters.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_DEVELOPER

Oracle DMW Object Operations

Filter: Mark as Public in Dev

Parent topic: Filters

Data Lineage Tracing

Users assigned the Oracle DMW_STUDY_DEVELOPER role have access to the following operations for data lineage tracing.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_DEVELOPER

Oracle DMW Object Operations

Table Instance: View CTX Data Lineage

Parent topic: Data Lineage Tracing

Transformations and Query Builder

Users assigned the Oracle DMW_STUDY_DEVELOPER role have access to the following operations for transformations and the query builder.

Parent topic: Oracle DMW_STUDY_DEVELOPER

Oracle LSH Object Operations

Application Area: Create Work Area
Domain: Create Program
Domain: Create Variable
Execution Setup: Modify Val Status to PROD
Execution Setup: Modify Val Status to QC
Execution Setup: Submit
Program: Modify Val Status to PROD
Program: Modify Val Status to QC
Program: Modify
Program: Remove
Program Instance: Modify Val Status to PROD
Program Instance: Modify Val Status to QC
Program Instance: Create Execution Setup
Program Instance: Modify
Program Instance: Remove
Table: Modify Val Status to PROD
Table: Modify Val Status to QC
Table Instance: Modify Val Status to PROD
Table Instance: Modify Val Status to QC
Table Instance: BlindBreak
Table Instance: ReadData
Table Instance: ReadUnblind
Table Instance: Remove
Table Instance: Unblind
Table Instance: Modfiy
Table: Modify
Table: Remove
Table: View
Work Area: Create Program Instance
Work Area: Create Table Instance
Work Area: Deploy (Install)
Work Area: Modify
Work Area: Delete
Work Area: Modify Val Status to PROD
Work Area: Modify Val Status to QC

Parent topic: Transformations and Query Builder

Oracle DMW Object Operations

Data Model: Load Data in Development
Domain: Create Transformation Map
Transformation Map: Modify
Transformation Map: Delete
Transformation Map: View
Transformation Map: Modify Validation Status QC
Transformation Map: Modify Validation Status Production
Transformation Map: Modify Supporting Info
Transformation Map: Deploy (Install) in Development
Transformation Map: Modify Security
Transformation Map: Classify

Parent topic: Transformations and Query Builder

Discrepancies and Flags

Users assigned the Oracle DMW_STUDY_DEVELOPER role have access to the following operations for discrepancies and flags.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_DEVELOPER

Oracle DMW Object Operations

Table Instance: Create Manual Discrepancy
Table Instance: Close Discrepancy
Table Instance: Send Discrepancy to InForm
Table Instance: Send Discrepancy to Spreadsheet
Table Instance: Reopen Discrepancy
Table Instance: Answer Discrepancy
Table Instance: Cancel Discrepancy
Table Instance: Add Comment to Discrepancy
Table Instance: Edit Discrepancy
Table Instance: Show Discrepancies
Table Instance: Assign Flags

Parent topic: Discrepancies and Flags

Validation Checks

Users assigned the Oracle DMW_STUDY_DEVELOPER role have access to the following operations for validation checks.

Parent topic: Oracle DMW_STUDY_DEVELOPER

Oracle LSH Object Operations

Domain: Create Program
Execution Setup: Modify Val Status to PROD
Execution Setup: Modify Val Status to QC
Execution Setup: Submit
Program: Modify Val Status to PROD
Program: Modify Val Status to QC
Program: Modify
Program: Remove
Program Instance: Modify Val Status to PROD
Program Instance: Modify Val Status to QC
Program Instance: Create Execution Setup
Program Instance: Modify
Program Instance: Remove
Table: Modify Val Status to PROD
Table: Modify Val Status to QC
Table: Modify
Table: Remove
Work Area: Create Program Instance

Parent topic: Validation Checks

Oracle DMW Object Operations

Data Model: Create VC Batch
VC Batch: Modify
VC Batch: Delete
VC Batch: View
VC Batch: Modify Validation Status QC
VC Batch: Modify Validation Status Production
VC Batch: Modify Supporting Info
VC Batch: Deploy (Install) in Development
VC Batch: Submit in Development
VC Batch: Submit Individual VC in Development
VC Batch: View Listings in Development

Parent topic: Validation Checks

InForm

Users assigned the Oracle DMW_STUDY_DEVELOPER role have access to the following operations for InForm clinical data models.

Parent topic: Oracle DMW_STUDY_DEVELOPER

Oracle LSH Object Operations

Application Area: Create Program
Load Set Instance: Create Execution Setup
Program Instance: Create Execution Setup
Program: Modify
Program Instance: Modify

Parent topic: InForm

Oracle DMW Object Operations

Data Model: Load Data in Development
Data Model: Load InForm Metadata
Web Service Location: Modify Web Service Location
Web Service Location: Create Connection

Parent topic: InForm

File Watcher

Users assigned the Oracle DMW_STUDY_DEVELOPER role have access to the following operations for the File Watcher.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_DEVELOPER

Oracle DMW Object Operations

Data Model: File Watcher Config
Data Model: Data Load DEV

Parent topic: File Watcher

Oracle DMW_STUDY_QC

The Oracle DMW_STUDY_QC object security role is intended for users who conduct formal testing of study objects including data models, transformations, and validation checks. They also need the ability to load data into the Quality Control lifecycle area from InForm and files, create custom listings, create and act on discrepancies, and assign flags to records. Blinding-related privileges are also included in this role.

Users with this role should have the Oracle DMW_STUDY_MANAGER or Oracle DMW_STUDY_CONFIG application role.

Oracle DMW_STUDY_QC allows users to perform the following operations on the specified objects.

Parent topic: Predefined object security roles

Clinical Data Models and Query Builder

Users assigned the Oracle DMW_STUDY_QC role have access to the following operations for clinical data models and the query builder.

Parent topic: Oracle DMW_STUDY_QC

Oracle LSH Object Operations

Load Set Instance: Modify
Load Set Instance: Modify Val Status to QC
Load Set Instance: Modify Val Status to PROD
Table Instance: Modify
Table Instance: Remove
Table Instance: Modify Val Status to QC
Table Instance: Modify Val Status to PROD
Work Area: Create Table Instance
Work Area: Create Load Set Instance
Work Area: Modify
Work Area: Modify Val Status to QC
Work Area: Modify Val Status to PROD
Work Area: Deploy (Install)

Parent topic: Clinical Data Models and Query Builder

Oracle DMW Object Operations

Data Model: View
Data Model: Publish QC (used to install the QC Work Area)
Data Model: Modify Supporting Info
Data Model: Modify Val Status to QC
Data Model: Modify Val Status to PROD
Data Model: Create Private Listing
Filter: Mark Filter Public QC

Parent topic: Clinical Data Models and Query Builder

Blinding

Users assigned the Oracle DMW_STUDY_QC role have access to the following operations for blinded data.

Oracle LSH Object Operations

Parent topic: Oracle DMW_STUDY_QC

Oracle LSH Object Operations

Table Instance: ReadData
Table Instance: BlindBreak
Table Instance: Unblind
Table Instance: ReadUnblind

Parent topic: Blinding

Discrepancies

Users assigned the Oracle DMW_STUDY_QC role have access to the following operations for discrepancies.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_QC

Oracle DMW Object Operations

Table Instance: Create Manual Discrepancy
Table Instance: Close Discrepancy
Table Instance: Send Discrepancy to InForm
Table Instance: Send Discrepancy to Spreadsheet
Table Instance: Reopen Discrepancy
Table Instance: Answer Discrepancy
Table Instance: Cancel Discrepancy
Table Instance: Add Comment to Discrepancy
Table Instance: Edit Discrepancy
Table Instance: Show Discrepancies

Parent topic: Discrepancies

Filters

Users assigned the Oracle DMW_STUDY_QC role have access to the following operation for filters.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_QC

Oracle DMW Object Operations

Filter: Mark as Public in QC

Parent topic: Filters

Flags

Users assigned the Oracle DMW_STUDY_QC role have access to the following operations for flags.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_QC

Oracle DMW Object Operations

Table Instance: Assign Flags

Parent topic: Flags

Data Lineage Tracing

Users assigned the Oracle DMW_STUDY_QC role have access to the following operations for data lineage tracing.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_QC

Oracle DMW Object Operations

Table Instance: View CTX Data Lineage

Parent topic: Data Lineage Tracing

Validation Checks

Users assigned the Oracle DMW_STUDY_QC role have access to the following operations for validation checks.

Parent topic: Oracle DMW_STUDY_QC

Oracle LSH Object Operations

Execution Setup: Modify Val Status to PROD
Execution Setup: Modify Val Status to QC
Execution Setup: Submit
Program: Modify Val Status to PROD
Program: Modify Val Status to QC
Program Instance: Modify Val Status to PROD
Program Instance: Modify Val Status to QC
Program Instance: Create Execution Setup
Table: Modify Val Status to PROD
Table: Modify Val Status to QC
Work Area: Create Program Instance

Parent topic: Validation Checks

Oracle DMW Object Operations

VC Batch: View
VC Batch: Modify Validation Status QC
VC Batch: Modify Validation Status Production
VC Batch: Modify Supporting Info
VC Batch: Deploy (Install) in Quality Control
VC Batch: Submit in Quality Control
VC Batch: Submit Individual VC in Quality Control
VC Batch: View Listings in Quality Control

Parent topic: Validation Checks

InForm

Users assigned the Oracle DMW_STUDY_QC role have access to the following operations for InForm clinical data models.

Parent topic: Oracle DMW_STUDY_QC

Oracle LSH Object Operations

Application Area: Create Program
Load Set Instance: Create Execution Setup
Program Instance: Create Execution Setup
Program: Modify
Program: View
Program: Modify Validation QC
Program Instance: Modify
Program Instance: View
Program Instance: Modify Validation QC
Work Area: Clone

Parent topic: InForm

Oracle DMW Object Operations

Data Model: Load Data in QC

Parent topic: InForm

File Watcher

Users assigned the Oracle DMW_STUDY_QC role have access to the following operations for the File Watcher.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_QC

Oracle DMW Object Operations

Data Model: FWR Configuration
Data Model: Data Load QC

Parent topic: File Watcher

Transformations and Query Builder

Users assigned the Oracle DMW_STUDY_QC role have access to the following operations for transformations and the query builder.

Parent topic: Oracle DMW_STUDY_QC

Oracle LSH Object Operations

Execution Setup: Modify Val Status to PROD
Execution Setup: Modify Val Status to QC
Execution Setup: Submit
Program: Modify Val Status to PROD
Program: Modify Val Status to QC
Program Instance: Modify Val Status to PROD
Program Instance: Modify Val Status to QC
Program Instance: Create Execution Setup
Table: Modify Val Status to PROD
Table: Modify Val Status to QC
Table Instance: Modify Val Status to PROD
Table Instance: Modify Val Status to QC
Table Instance: BlindBreak
Table Instance: ReadData
Table Instance: ReadUnblind
Work Area: Create Program Instance
Work Area: Create Table Instance
Work Area: Deploy (Install)
Work Area: Modify
Work Area: Modify Val Status to PROD
Work Area: Modify Val Status to QC

Parent topic: Transformations and Query Builder

Oracle DMW Object Operations

Data Model: Load Data in Quality Control
Transformation Map: View
Transformation Map: Modify Validation Status QC
Transformation Map: Modify Validation Status Production
Transformation Map: Modify Supporting Info
Transformation Map: Deploy (Install) in Quality Control
Transformation Map: Modify Pvt Listing
Transformation Map: Delete Pvt Listing
Transformation Map: View Public Listing

Parent topic: Transformations and Query Builder

Oracle DMW_STUDY_PROD

The Oracle DMW_STUDY_PROD role is intended for users who work in the Production environment, including: promoting and installing clinical data models, transformations, and validation checks, loading production data from InForm and files, running transformations and validation checks on production data, reviewing data and creating custom listings, and creating and acting on discrepancies. Blinding-related privileges are also included in this role.

Users with this role should have the Oracle DMW_STUDY_MANAGER application role.

Oracle DMW_STUDY_PROD allows users to perform the following operations on the specified objects.

Parent topic: Predefined object security roles

Clinical Data Models and Query Builder

Users assigned the Oracle DMW_STUDY_PROD role have access to the following operations for clinical data models and the query builder.

Parent topic: Oracle DMW_STUDY_PROD

Oracle LSH Object Operations

Load Set Instance: Modify
Load Set Instance: Modify Val Status to QC
Load Set Instance: Modify Val Status to PROD
Work Area: Create Table Instance
Table Instance: Modify
Table Instance: Remove
Table Instance: Modify Val Status to QC
Table Instance: Modify Val Status to PROD
Work Area: Create Loadset Instance
Work Area: Modify
Work Area: Modify Val Status to QC
Work Area: Modify Val Status to PROD
Work Area: Deploy (Install)

Parent topic: Clinical Data Models and Query Builder

Oracle DMW Object Operations

Data Model: View
Data Model: Publish Prod (used to install the Production Work Area)
Data Model: Modify Supp Info
Data Model: Modify Val Status to QC
Data Model: Modify Val Status to PROD
Data Model: Create Private Listing
Filter: Mark Filter Public PROD

Parent topic: Clinical Data Models and Query Builder

Blinding

Users assigned the Oracle DMW_STUDY_PROD role have access to the following operations for blinded data.

Oracle LSH Object Operations

Parent topic: Oracle DMW_STUDY_PROD

Oracle LSH Object Operations

Table Instance: BlindBreak
Table Instance: Unblind
Table Instance: ReadUnblind
Table Instance: ReadData

Parent topic: Blinding

Discrepancies

Users assigned the Oracle DMW_STUDY_PROD role have access to the following operations for discrepancies.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_PROD

Oracle DMW Object Operations

Table Instance: Create Manual Discrepancy
Table Instance: Close Discrepancy
Table Instance: Send Discrepancy to InForm
Table Instance: Send Discrepancy to Spreadsheet
Table Instance: Reopen Discrepancy
Table Instance: Answer Discrepancy
Table Instance: Cancel Discrepancy
Table Instance: Add Comment to Discrepancy
Table Instance: Edit Discrepancy
Table Instance: Show Discrepancies
Table Instance: Create Data Amendment
Table Instance: Modify Data Amendment
Table Instance: Cancel Data Amendment

Parent topic: Discrepancies

Filters

Users assigned the Oracle DMW_STUDY_PROD role have access to the following operation for filters.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_PROD

Oracle DMW Object Operations

Filter: Mark as Public in Prod

Parent topic: Filters

Flags

Users assigned the Oracle DMW_STUDY_PROD role have access to the following operations for flags.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_PROD

Oracle DMW Object Operations

Table Instance: Assign Flags

Parent topic: Flags

Data Lineage Tracing

Users assigned the Oracle DMW_STUDY_PROD role have access to the following operations for data lineage tracing.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_PROD

Oracle DMW Object Operations

Table Instance: View CTX Data Lineage

Parent topic: Data Lineage Tracing

Validation Checks

Users assigned the Oracle DMW_STUDY_PROD role have access to the following operations for validation checks.

Parent topic: Oracle DMW_STUDY_PROD

Oracle LSH Object Operations

Execution Setup: Modify Val Status to PROD
Execution Setup: Modify Val Status to QC
Execution Setup: Submit
Program: Modify Val Status to PROD
Program: Modify Val Status to QC
Program Instance: Modify Val Status to PROD
Program Instance: Modify Val Status to QC
Program Instance: Create Execution Setup
Table: Modify Val Status to PROD
Table: Modify Val Status to QC
Work Area: Create Program Instance

Parent topic: Validation Checks

Oracle DMW Object Operations

VC Batch: View
VC Batch: Modify Validation Status QC
VC Batch: Modify Validation Status Production
VC Batch: Modify Supporting Info
VC Batch: Deploy (Install) in Production
VC Batch: Submit in Production
VC Batch: Submit Individual VC in Production
VC Batch: View Listings in Production

Parent topic: Validation Checks

InForm

Users assigned the Oracle DMW_STUDY_PROD role have access to the following operations for InForm data.

Parent topic: Oracle DMW_STUDY_PROD

Oracle LSH Object Operations

Application Area: Create Program
Load Set Instance: Create Execution Setup
Program: Modify
Program: Modify Validation PROD
Program Instance: Create Execution Setup
Program Instance: Modify
Program Instance: Modify Validation PROD
Work Area: Clone

Parent topic: InForm

Oracle DMW Object Operations

Data Model: Load Data in Production

Parent topic: InForm

File Watcher

Users assigned the Oracle DMW_STUDY_PROD role have access to the following operations for the File Watcher.

Oracle DWM Object Operations

Parent topic: Oracle DMW_STUDY_PROD

Oracle DWM Object Operations

Data Model: FWR Configuration
Data Model: Data Load PROD

Parent topic: File Watcher

Transformations and Query Builder

Users assigned the Oracle DMW_STUDY_PROD role have access to the following operations for transformations and the query builder.

Parent topic: Oracle DMW_STUDY_PROD

Oracle LSH Object Operations

Execution Setup: Modify Val Status to PROD
Execution Setup: Modify Val Status to QC
Execution Setup: Submit
Program: Modify Val Status to PROD
Program: Modify Val Status to QC
Program Instance: Modify Val Status to PROD
Program Instance: Modify Val Status to QC
Program Instance: Create Execution Setup
Table: Modify Val Status to PROD
Table: Modify Val Status to QC
Table Instance: Modify Val Status to PROD
Table Instance: Modify Val Status to QC
Table Instance: BlindBreak
Table Instance: ReadData
Table Instance: ReadUnblind
Work Area: Create Program Instance
Work Area: Create Table Instance
Work Area: Deploy (Install)
Work Area: Modify
Work Area: Modify Val Status to PROD
Work Area: Modify Val Status to QC

Parent topic: Transformations and Query Builder

Oracle DMW Object Operations

Data Model: Load Data in Production
Transformation Map: View
Transformation Map: Modify Validation Status QC
Transformation Map: Modify Validation Status Production
Transformation Map: Modify Supporting Info
Transformation Map: Deploy (Install) in Production
Transformation Map: Modify Pvt Listing
Transformation Map: Delete Pvt Listing
Transformation Map: View Public Listing

Parent topic: Transformations and Query Builder

Oracle DMW_STUDY_ADMIN

The Oracle DMW_STUDY_ADMIN object security role is intended for superusers. It includes the object-related roles that Oracle DMW_STUDY_DEVELOPER and Oracle DMW_STUDY_QC have, plus administrator privileges including creating studies and study categories, setting up connections to InForm and File Watcher locations, and assigning user groups to objects such as data models, transformations, and validation checks. Blinding-related privileges are also included in this role.

Users with this role should have the Oracle DMW_STUDY_MANAGER or Oracle DMW_SYS_ADMIN application role.

Oracle DMW_STUDY_ADMIN allows users to perform the following operations on the specified objects.

Parent topic: Predefined object security roles

Clinical Data Models and Query Builder

Users assigned the Oracle DMW_STUDY_ADMIN role have access to the following operations for clinical data models and the query builder.

Parent topic: Oracle DMW_STUDY_ADMIN

Oracle LSH Object Operations

Application Area: Manage Security
Application Area: Create Work Area
Application Area: Create Program
Domain: Create SubDomain
Domain: Modify
Domain: Delete
Domain: Manage Security
Domain: Create Load Set
Domain: Create Variable
Domain: Create Program
Domain: Create Data Model
Domain: Create Transformation Map
Table Instance: Manage Security
Work Area: Manage Security
Work Area: Create Table Instance
Work Area: Create Load Set Instance
Work Area: Modify
Work Area: Modify Val Status to QC
Work Area: Modify Val Status to PROD
Work Area: Delete
Work Area: Deploy (Install)
Work Area: Create Program Instance
Variable: Modify
Variable: Modify Val Status to QC
Variable: Modify Val Status to PROD

Parent topic: Clinical Data Models and Query Builder

Oracle DMW Object Operations

Data Model: Create Private Listing
Data Model: Create Public Listing
Data Model: Modify
Data Model: Delete
Data Model: Deploy (Install) Model in Dev/QC/Prod
Data Model: Modify Supporting Info
Data Model: Modify Val Status to QC
Data Model: Modify Val Status to PROD
Data Model: Create VC Batch
Data Model: Load Data in Dev/QC/Prod
Data Model: Manage Security
Data Model: Configure InForm
Data Model: Load InForm Metadata
Filter: Mark Filter Public Dev
Filter: Mark Filter Public QC
Filter: Mark Filter Public Prod

Parent topic: Clinical Data Models and Query Builder

Discrepancies

Users assigned the Oracle DMW_STUDY_ADMIN role have access to the following operations for discrepancies.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_ADMIN

Oracle DMW Object Operations

Table Instance: Create Manual Discrepancy
Table Instance: Close Discrepancy
Table Instance: Send Discrepancy to InForm
Table Instance: Send Discrepancy to Spreadsheet
Table Instance: Reopen Discrepancy
Table Instance: Answer Discrepancy
Table Instance: Cancel Discrepancy
Table Instance: Add Comment to Discrepancy
Table Instance: Edit Discrepancy
Table Instance: Show Discrepancies
VC Batch: Modify
VC Batch: Delete
VC Batch: View
VC Batch: Modify Validation Status Production
VC Batch: Modify Supporting Info
VC Batch: Deploy (Install) in Development/QC/Prod
VC Batch: Submit in Development/QC/Prod
VC Batch: Submit in Individual VC in Development/QC/Prod
VC Batch: View Listings in Development/QC/Prod

Parent topic: Discrepancies

Flags

Users assigned the Oracle DMW_STUDY_ADMIN role have access to the following operations for flags.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_ADMIN

Oracle DMW Object Operations

Table Instance: Assign Flags

Parent topic: Flags

Filters

Users assigned the Oracle DMW_STUDY_ADMIN role have access to the following operations for filters.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_ADMIN

Oracle DMW Object Operations

Filter: Mark as Public in Dev
Filter: Mark as Public in QC
Filter: Mark as Public in Prod

Parent topic: Filters

Data Lineage Tracing

Users assigned the Oracle DMW_STUDY_ADMIN role have access to the following operations for data lineage tracing.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_ADMIN

Oracle DMW Object Operations

Table Instance: View CTX Data Lineage

Parent topic: Data Lineage Tracing

Validation Checks

Users assigned the Oracle DMW_STUDY_ADMIN role have access to the following operations for validation checks.

Parent topic: Oracle DMW_STUDY_ADMIN

Oracle LSH Object Operations

Execution Setup: Manage Security
Program: Manage Security
Program Instance: Manage Security
Program: Modify Val Status to PROD
Program: Modify Val Status to QC
Program: Modify
Program: Remove
Program Instance: Modify Val Status to PROD
Program Instance: Modify Val Status to QC
Program Instance: Create Execution Setup
Program Instance: Modify
Program Instance: Remove
Table: Manage Security
Table: View
Table: Modify
Table: Modify Val Status to PROD
Table: Modify Val Status to QC
Table: Remove

Parent topic: Validation Checks

Oracle DMW Object Operations

VC Batch: Manage Security
VC Batch: Modify
VC Batch: Delete
VC Batch: View
VC Batch: Modify Validation Status Production
VC Batch: Modify Supporting Info
VC Batch: Deploy (Install) in Development/QC/Prod
VC Batch: Submit in Developmene/QC/Prod
VC Batch: Submit in Individual VC in Development/QC/Prod
VC Batch: View Listings in Development/QC/Prod

Parent topic: Validation Checks

InForm

Users assigned the Oracle DMW_STUDY_ADMIN role have access to the following operations for InForm.

Parent topic: Oracle DMW_STUDY_ADMIN

Oracle LSH Object Operations

Adapter Area: Create Remote Location
Adapter Area: Create Web Service Location
Connection: Modify
Connection: Delete
Remote Location: Modify
Remote Location: View
Remote Location: Create Connection
Remote Location: Delete

Parent topic: InForm

Oracle DMW Object Operations

Data Model: Configure InForm
Data Model: Load InForm Metadata
Web Service Location: Modify Web Service Location
Web Service Location: Create Connection
Web Service Location: Delete Web Service Location
Web Service Location: View

Parent topic: InForm

File Watcher

Users assigned the Oracle DMW_STUDY_ADMIN role have access to the following operations for the File Watcher.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_ADMIN

Oracle DMW Object Operations

Data Model: FWR Configuration

Parent topic: File Watcher

Transformations and Query Builder

Users assigned the Oracle DMW_STUDY_ADMIN role have access to the following operations for transformations and the query builder.

Parent topic: Oracle DMW_STUDY_ADMIN

Oracle LSH Object Operations

Application Area: Manage Security
Domain: Manage Security
DataModel: Manage Security
Execution Setup: Modify Val Status to PROD
Execution Setup: Modify Val Status to QC
Execution Setup: Submit
Execution Setup: Manage Security
Program: Manage Security
Program: Manage Security
Program: Modify Val Status to PROD
Program: Modify Val Status to QC
Program: Modify
Program: Remove
Program Instance: Modify Val Status to PROD
Program Instance: Modify Val Status to QC
Program Instance: Create Execution Setup
Program Instance: Modify
Program Instance: Remove
Table: Manage Security
Table Instance: Manage Security
Table Instance: Modify
Table Instance: Remove
Table Instance: Modify Val Status to QC
Table Instance: Modify Val Status to PROD
Table Instance: ReadData
Table Instance: BlindBreak
Table Instance: Unblind
Table Instance: ReadUnblind
VC Batch: Manage Security
Work Area: Manage Security

Parent topic: Transformations and Query Builder

Oracle DMW Object Operations

Transformation Map: Modify Private Listing
Transformation Map: Delete Private Listing
Transformation Map: Modify Public Listing
Transformation Map: View Public Listing
Transformation Map: Delete Public Listing
Transformation Map: Manage Security for Public Listing
Transformation Map: Modify Val Stat QC for Public Listing
Transformation Map: Modify Val Stat PROD for Public Listing
Transformation Map: Modify Supporting Info
Transformation Map: Modify
Transformation Map: Delete
Transformation Map: View
Transformation Map: Modify Validation Status QC
Transformation Map: Modify Validation Status PROD
Transformation Map: Modify Supporting Info
Transformation Map: Deploy (Install) in Development/QC/PROD
Transformation Map: Modify Security
Transformation Map: Classify

Parent topic: Transformations and Query Builder

Oracle DMW_STUDY_INST_ACCESS

The Oracle DMW_STUDY_INST_ACCESS role is intended for users who require only View access to data and discrepancy listings. Blinding-related privileges are also included in this role.

Users with this role should have the Oracle DMW_STUDY_CONSUMER application role.

The Oracle DMW_STUDY_INST_ACCESS role allows users to perform the following operations on the specified objects.

Parent topic: Predefined object security roles

Clinical Data Models and Query Builder

Users assigned the Oracle DMW_STUDY_INST_ACCESS role have access to the following operations for clinical data models and the query builder.

Oracle LSH Object Operations

Parent topic: Oracle DMW_STUDY_INST_ACCESS

Oracle LSH Object Operations

Domain: View
Data Model: View
Table Instance: View
Work Area: View

Parent topic: Clinical Data Models and Query Builder

Blinding

Users assigned the Oracle DMW_STUDY_INST_ACCESS role have access to the following operations for blinded data.

Oracle LSH Object Operations

Parent topic: Oracle DMW_STUDY_INST_ACCESS

Oracle LSH Object Operations

Table Instance: ReadData
Table Instance: BlindBreak
Table Instance: Unblind
Table Instance: ReadUnblind

Parent topic: Blinding

Discrepancies

Users assigned the Oracle DMW_STUDY_INST_ACCESS role have access to the following operations for discrepancies.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_INST_ACCESS

Oracle DMW Object Operations

Table Instance: Show Discrepancies

Parent topic: Discrepancies

Data Lineage Tracing

Users assigned the Oracle DMW_STUDY_INST_ACCESS role have access to the following operations for data lineage tracing.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_INST_ACCESS

Oracle DMW Object Operations

Table Instance: View Data Lineage Tracing

Parent topic: Data Lineage Tracing

Validation Checks

Users assigned the Oracle DMW_STUDY_INST_ACCESS role have access to the following operations for validation checks.

Oracle DMW Object Operations

Parent topic: Oracle DMW_STUDY_INST_ACCESS

Oracle DMW Object Operations

VC Batch: View
VC Batch: View Listings in Development

Parent topic: Validation Checks

Transformations

Users assigned the Oracle DMW_STUDY_INST_ACCESS role have access to the following operations for transformations.

Oracle LSH Object Operations

Parent topic: Oracle DMW_STUDY_INST_ACCESS

Oracle LSH Object Operations

Table Instance: BlindBreak
Table Instance: ReadData
Table Instance: ReadUnblind

Parent topic: Transformations

Oracle DMW_STUDY_INFORM_CONFIG

This role has the privileges required to configure the link to InForm for an input clinical data model.

InForm

Parent topic: Predefined object security roles

InForm

Users assigned the Oracle DMW_STUDY_INFORM_CONFIG role have access to the following operations for InForm clinical data models.

Parent topic: Oracle DMW_STUDY_INFORM_CONFIG

Oracle LSH Object Operations

Adapter Area: Create Remote Location
Adapter Area: Create Web Service Location
Connection: Modify
Remote Location: Create Connection
Remote Location: Modify

Parent topic: InForm

Oracle DMW Object Operations

Domain: Create Data Model
Data Model: InForm Config
Data Model: Modify Data Model
Data Model: Delete Data Model

Parent topic: InForm

Operations

Most operations are self-explanatory. A few that may not be:

Manage Security is required to assign user groups to an object (functional area).
Modify Validation Status Production/QC is required to promote an object to a higher validation status, either Production or Quality Control.

Supporting information is documentation uploaded to justify promotion to a higher validation status.
Deploy (found in the Transformation Maps functional area) is required for users who create and test transformations and validation checks.
Users who create and test clinical data models, transformations, validation checks, custom programs, and custom listings need the install operation on Work Areas.
The data amendment operations on table instances are not used in DMW .

Operations required to view data and manage discrepancies

Parent topic: Security reference information

Operations required to view data and manage discrepancies

On the Table Instance functional area:
- View, View Data, View Data Lineage on Custom Listing, and the appropriate discrepancy-related operations.
- As appropriate: View Unblinded Data, Unblind Data, and/or Blind Break to view currently blinded data.
If the user should be able to create custom listings, he or she also needs:
- On Application Areas: Create Program, Parameter, Variable, and Table
- On Work Areas: Create Program Instance and Table Instance, Install, Modify, and View
- On Execution Setups: Submit

Parent topic: Operations

Object ownership

Figure 7-1 represents the relationships among objects in DMW. Object-owning relationships affect which user groups can access which objects. If a user group is assigned to an object, the user group gains access to all objects contained in that object by inheritance. You can explicitly revoke this inherited access, which also revokes access to any objects contained in that object.

Figure 7-1 Object ownership

Description of "Figure 7-1 Object ownership"

Parent topic: Security reference information