Data Manager

This topic describes the permissions included in the Data Manager (template) study role in the application. This template study role is available for all studies in your organization. You can copy the study role and customize it for each individual study you work in.

A user who is assigned this predefined study role template can also manage tasks related to integrations between Oracle Clinical One Platform and:
  • A third-party electronic data capture system
  • Oracle Health Sciences InForm
  • Veeva Vault CTMS
  • Oracle Siebel Clinical Trial Management System

Permissions given to a data manager based on their responsibilities

Note:

To see an overview of all permissions that can be included in study roles, see the View Permissions window in the application.

Table 8-4 Data Manager (template) study role

Category Permissions assigned

CRF Submit Access

  • Run and Download Site Confirmation and Download Log Audit Reports
  • Run and Download all PDF Request Types and Audit Reports. Enable Share with Sites, and Site Confirmation

Clinical Data Collection

  • Add a Lab to a Site
  • Add and Update Lab Normal Ranges
  • Create and Add Labs to a Site
  • Edit Classified Subject Data Only
  • Freeze subject data entered at a site
  • Lock Subject Data at a Site
  • Unfreeze subject data entered at a site
  • View Classified Subject Data Only
  • View Form Data for Subjects
  • View Queries

Data Extract

  • Run the Subject Data Extract

Notifications

  • Receive the Code Break Notification
  • Receive the Study Limits Notifications
  • Receive the Subject Completion Notification
  • Receive the Subject Rollover Notification

Reports

  • Schedule Reports to Run
  • Run the Blinded Subject Events Dataset
  • Run the Data Collection Design Dataset
  • Run the Kit Dispensation Report
  • Run the Kits and Randomization Design Dataset
  • Run the Study Codelist Dataset (planned for a future release)
  • Run the Study Design Report
  • Run the Study Query Dataset
  • Run the Subject Data Report
  • Run the Subject Data for CTMS Report
  • Run the Subject Events Report
  • Run the Subject Form Items Dataset
  • Run the Subject Forms Dataset
  • Run the Subject Query Report

Study Management

  • Close Queries
  • Create Candidate Queries
  • Create Queries
  • Delete Candidate Queries
  • View All Queries

Study Setup

  • View Role Assignments for Study Users
  • View Study Design
  • View Subject Settings