User Roles It is up to the discretion of the project PI in conjunction with the study team to set up User Rights & Rolesin a project. In order for a study to be Part 11 Compliant, project sponsor / investigator roles and responsibilities must be clearly articulated to provide awareness to sponsors and investigators of responsibilities to adequately conduct clinical trials. It is important to separate roles and their designated rights in each project. The following examples would meet Part 11 compliance for separation of concerns: Administrator Auditor / Monitor Data Entry Analyst Principle Investigator Study Coordinator
 Note: The eConsent REDCap Template includes the Principal Investigator and Study Coordinator roles. Please add additional roles per your project needs. |