Data Safety and Monitoring

Principal investigator:

  • Audits the research process on a regular basis, and documents this audit
  • Reports adverse events to the IRB according to institutional policy and IRB procedures, and to DSMBs, sponsors and appropriate federal agencies as required

Other research personnel: N/A

Department/center/project financial officer: N/A

Department chair/center director:

  • Assures that project is in compliance with state, federal, sponsor and University of Utah policies and regulations regarding human subjects protection
  • Promotes University compliance efforts and programs regarding human subjects protection within department/center, as relevant

Deans office/designee:

  • Promotes University compliance efforts and programs regarding human subjects protection within college/school, as relevant

Executive administration:

  • Promotes University compliance efforts and programs regarding human subjects protection

Conflict of Interest committee: N/A

Environmental Health and Safety, Department: N/A

Governmental Accounting and Support Services: N/A

Institutional Animal Care and Use Committee / Animal Resource Center: N/A

Institutional Review Board:

  • Assures adequate protection for monitoring data collected
  • Receives and acts on reports of adverse events according to institutional policy and IRB procedures, and forwards relevant information to DSMBs, sponsors and appropriate federal agencies as required

Office of Internal Audit: N/A

Radiological Health, Department: N/A

Institutional BiosafetyCommittee : N/A

Office of Sponsored Projects: N/A

Technology Transfer Office: N/A