Rules Designer

This topic describes the permissions included in the Rules Designer (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.

Permissions given to a rule designer 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 8-10 Rules Designer (template) study role

Category Permissions assigned

Administrative

  • Run the Study Roles Report

CRF Submit Access

  • Run Archival PDFs for your site(s)

Clinical Data Collection

  • Add a Lab to a Site
  • Add and Update Lab Normal Ranges
  • Create and Add Labs to a Site
  • Dispense Kits with Calculated Doses
  • Edit Classified Subject Data Only
  • Edit Form Data for Subjects
  • Edit Visit Dates
  • Randomize Subjects
  • Skip Visits
  • Take Action on Connected Devices
  • Unblind the Treatment Arm for a Subject or Code Break
  • View Classified Subject Data Only
  • View Form Data for Subjects
  • View Queries

Data Extract

  • Run the Subject Data Extract

Inventory Management

  • View Shipments to Sites
  • View Unblinded Pharmacist Kits

Reports

  • Run the Blinded Inventory Report
  • Run the Blinded Randomization Report
  • Run the Data Collection Design Dataset
  • Run the Enrollment Report
  • Run the Kit Dispensation Report
  • Run the Kit Reconciliation Report
  • Run the Kits and Randomization Design Dataset
  • Run the Order Summary Report
  • Run the Site and Depot Report
  • Run the Study Codelist Dataset (planned for a future release)
  • Run the Study Design Report
  • Run the Study Query Dataset
  • Run the Study Rules Report
  • Run the Subject Data Report
  • Run the Subject Events Report
  • Run the Subject Form Items Dataset
  • Run the Subject Query Report
  • Run the Subject Visit Report
  • Run the Titration Summary Report
  • Run the Training Report
  • Run the Unblinded Chain of Custody Report
  • Run the Unblinded Inventory Report
  • Run the Unblinded Randomization Report
  • Run the Unblinded Subject Visit Schedule Report
  • Run the Unblinded Titration Summary Report
  • Run the User Assignment Report

Rules Management

  • Design Custom Rules
  • Publish Custom Rules
  • Re-run Rules
  • Test Custom Rules

Settings

  • Configure Connected Device Study Settings
  • Edit Welcome Details in General Study Settings

Study Management

  • Transfer subjects between sites
  • View All Queries

Study Setup

  • Assign a Resupply Strategy to a Site
  • Assign a SDV Strategy to a Site
  • Assign a Study Version to a Site
  • Create and Manage Lots
  • Create and Manage SDV Properties
  • Create and Manage Sites
  • Edit General Study Settings
  • Edit Regions
  • Edit Study Settings
  • Edit Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies
  • Move a Study Design to Testing or Production
  • Upload and Generate Inventory Lists
  • Upload and Generate Randomization Lists
  • View Role Assignments for Study Users
  • View Sites
  • View Study Design