Study Set-Up

Main Content

Staff Training and Delegation

Definitions

  • Staff training ensures that each team member completes the appropriate training for clinical research studies as required by the institution, sponsor, and applicable laws and regulations.
  • Delegation involves the assignment of different roles and responsibilities to various study team members to ensure the successful conduct and completion of a clinical research study.

Policies/guidelines

  • The overall responsibility for a clinical trial rests with the principal investigator. The principal investigator can delegate specific roles and responsibilities to various members within the study team.
  • The creation of a delegation log is required to track the roles and responsibilities delegated to study team members. The delegation log should include name, role, task, training details, etc.
  • UMMC-required training for investigators includes CITI training, - External site
  • A list of UMMC-required training for personnel functioning as clinical research coordinators (those working directly with research participants or supporting clinical research through data entry, data management, or regulatory support) offered through the Clinical Research Education for the Workforce (CREW) program can be accessed via the CREW website. 

Templates/forms

  • Example of a delegation log - External site (Created by the National Center for Complementary and Integrative Health)

Training

  • CITI training (external site) must be completed in order to gain access to the Institutional Review Board (IRB) submission portal, Ideate. For access, email the Human Research Office or call (601) 984-2815.