The following tables summarize the modules and features available to each of the User Roles at the Study and Site levels.

Summary of Available Modules and Features for User Roles at the Study Level

User Role

Modules and Main Features

Data Manager 

Submit Data:

  • Add and Manage Subjects
  • View, Schedule, and Enter Data into CRFs for Events
  • No Waiting to Perform Double Data Entry After Initial Data Entry
  • Import Data
  • Notes and Discrepancies

Monitor and Manage Data:

  • Study Audit Log and Source Data Verification
  • Manage Groups
  • Create, Edit, and Manage CRFs
  • Rules

Extract Data

Study Setup:

  • View and Build Study
  • Assign Users

Home page presents summary of current Study or Site.

Study Director 

Submit Data:

  • Add and Manage Subjects
  • View, Schedule, and Enter Data into CRFs for Events
  • No Waiting to Perform Double Data Entry After Initial Data Entry
  • Import Data
  • Notes and Discrepancies

Monitor and Manage Data:

  • Study Audit Log and Source Data Verification
  • Manage Groups
  • Create, Edit, and Manage CRFs
  • Rules

Extract Data

Study Setup:

  • View and Build Study
  • Assign Users

Home page presents summary of current Study or Site.

Data Specialist

Submit Data:

  • Add and Manage Subjects
  • View, Schedule, and Enter Data into CRFs for Events
  • Import Data
  • Notes and Discrepancies

Sign Subject data

Extract Data

Monitor

Monitor and Manage Data:

  • View Subjects
  • View Events
  • Study Audit Log and Source Data Verification
  • Notes and Discrepancies

Extract Data

Data Entry Person

Submit Data:

  • Add and Manage Subjects
  • View, Schedule, and Enter Data into CRFs for Events
  • Import Data
  • Notes and Discrepancies

 

Summary of Available Modules and Features for User Roles at the Site Level

User RoleModules and Main Features
Investigator

Submit Data:

  • Add and Manage Subjects
  • View, Schedule, and Enter Data into CRFs for Events
  • Import Data
  • Notes and Discrepancies

Sign Subject Data

Extract Data

Monitor (site)

Monitor and Manage Data:

  • View Subjects
  • View Events
  • Study Audit Log and Source Data Verification
  • Notes and Discrepancies

Extract Data

Clinical Research Coordinator

Submit Data:

  • Add and Manage Subjects
  • View, Schedule, and Enter Data into CRFs for Events
  • Import Data
  • Notes and Discrepancies

Data Entry Person

(Same as Clinical Research Coordinator; use to differentiate office job titles for similar job function if necessary.)

Submit Data:

  • Add and Manage Subjects
  • View, Schedule, and Enter Data into CRFs for Events
  • Import Data
  • Notes and Discrepancies