On this page:

• Introduction
• Contact Information
• Staff
• Services
  • Research
  • Systems Management
  • Regulatory Oversight/Monitoring

The Masonic Cancer Center Clinical Trials Office (CTO) at the University of Minnesota provides the infrastructure necessary to assist investigators in performing high-quality clinical research, insure the validity and integrity of data, and fulfill all National Cancer Institute (NCI) and regulatory requirements.

This infrastructure includes state-of-the-art information systems and database facilities, expertise in the development and management of clinical trials, and development of IND/IDE applications and monitoring plans.

The Clinical Trials Office provides a centralized location for all cancer protocols and associated correspondence with regulatory agencies including the University of Minnesota Institutional Review Board (IRB), National Institutes of Health, FDA, and Cancer Center investigator IND/IDE files.

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Contact Information

For general information and Cancer Protocol Review Committee (CPRC):
Charleen Pagel Jue
612-624-1959
juexx002@umn.edu

Clinical Trials Office
Masonic Cancer Center, University of Minnesota
Mayo Mail Code 806
420 Delaware St. S.E.
Minneapolis, MN 55455
612-625-3650
cto@umn.edu

Staff

Clinical Trials Office Director:
Scott Baker, M.D.,
612-625-4952
baker084@umn.edu

CTO Program Manager:
Charleen Jue
612-624-1959
juexx002@umn.edu

Budgets and contracts:
Susan Collins
612-624-0659
colli017@umn.edu

Audits:
Carol Letourneau
612-624-3191
letou003@umn.edu

Solid tumor studies:
Katie Mellskog
612-624-6490
mells003@umn.edu

BMT and leukemia studies:
Roby Nicklow
612-624-9452
rnicklo1@fairview.org

Monitoring:
Janet Sauers
612-624-3238
sauer090@umn.edu

Regulatory Affairs:
Janet Sauers
612-624-3238
sauer090@umn.edu

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Services

1. Research

Protocol Development:

• Site-Specific Team interface
• Protocol writing, editing and review
• Development of checklist
• Resource needs assessment
• Development of CRF's

Protocol Implementation:

• Staff assignments
• Site-Specific Team faculty and staff education
• Subject screening/recruitment
• Subject consent/eligibility verification
• Subject registration/randomization
• Protocol specific data collection/assessments
• HQOL measurements
• SAE reporting

Data Editing and Entry:

• Data editing
• Data entry/internal checking

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2. Systems Management

Nucleus/Protocol Database:

• Subject registration
• Subject tracking
• Assignment of database access

Central Filing:

• Protocol submission, amendments, and correspondence
• IND/IDE applications, amendments and correspondence
• CPRC reports, actions
• DSMC reports, actions

Finance:

• Protocol budget development
• Cost recovery program

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3. Regulatory/Oversight Monitoring:

• CTO manual of operations
• Protocol-specific SOPs
• Internal audits

Specialized Reporting:

• Site Specific Team reports
• Regulatory reports
• Administrative reports
• Sponsor reports
• CPRC DSMC audit reports

IND/IDE Registration:

• Protocol and IND/IDE writing assistance
• IND/IDE templates
• Administrative oversight

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