Clinical Trial Office FAQs

The Office of Clinical Trials (OCT) was established to strengthen and support the clinical trials enterprise across CU Anschutz. By bringing together existing programs, leadership, and shared systems, the OCT will improve coordination, reduce administrative barriers, and create more consistent processes to increase efficiencies and better support investigators, research teams, sponsors, and patients.

The OCT does not replace, but rather complements,departmental operations by focusing on shared infrastructure, aligned processes, and campus-wide support across the clinical trial lifecycle.

As the OCT continues to develop, additional information, resources, and guidance will be added to this site. The FAQs below provide an initial overview of the office, its purpose, and what toexpect in the months ahead.

The Office of Clinical Trials (OCT) is a campus-wide coordination office created to improve how clinical trials start up and operate at CU Anschutz. The OCT brings together existing programs, leadership, and shared systems to ensure efficiencies, improve quality and consistency, and support growth in clinical trials across departments, and broaden our overall research portfolio.

The OCT does not replace departmental research teams. Instead, it focuses on coordination, standardization, and support across the clinical trial lifecycle so that studies can open faster; run more smoothly; and better serve patients, investigators, and sponsors.

CU Anschutz has strong clinical trial expertise across departments, but trials have faced common challenges such as:

Slow and inconsistent study start-up timelines.
Fragmented processes across offices and institutions.
Financial and regulatory risk from lack of standardization.
Increasing competition for industry-sponsored trials.

The OCT was created to address these challenges by centralizing coordination (not control), improving transparency, and strengthening partnerships while preserving what already works well.

The new office brings together clinical trials operations in the Office of the Vice Chancellor for Research and the School of Medicine Office of Research in partnership with UCHealth Research Administration, led by Jean Kutner, MD, MSPH, UCHealth Chief Academic Officer, and Laurie Blumberg-Romero, Vice President of Research Administration, to further enhance the efficiency and effectiveness of clinical trials execution at CU Anschutz and UCHealth.

Child health clinical trials will continue under the ongoing CU Anschutz partnership with Children’s Hospital Colorado (CHCO) through the Colorado Child Health Research Institute (CCHRI), led by Ronald Sokol, MD, Chief Scientific Officer – Child Health and Associate Dean for Child Health Research, and Jenae Neiman, CHCO Vice President for Research Operations.

The Clinical Research Administration Office (CRAO), led by Cat Sutherland, including team members who support OnCore and calendar building

Clinical Research Recruitment and Novel Clinical Trials Programs, led by Kiley Vander Wyst

Clinical Research Support Team (CReST), led by Erin McDonagh, including monitoring team members

Clinical Research Workforce Development Program, led by Haley Steinert

These teams will be joined by CU Anschutz School of Medicine team members from Accelerating Solutions for Cell and Gene Therapy Evaluation and Novel Delivery (ASCEND), strategic industry partnerships, and new programs (e.g., the new Clinical Trials Data Coordination Center and Clinical Trials Training program).

The Clinical Research Support Team (CReST) can help with start-up, budgeting, coordination, regulatory support, invoicing, and general study administration.
CReST can assist with clinical monitoring, Electronic Data Capture (EDC) electronic Case Report Form (eCRF) development, and Data Safety Monitoring Board (DSMB) support.
The Recruitment Program can help with recruitment planning and problem solving, development of recruitment materials, curation of social media ads, and community engagement planning.
The Workforce Development Program provides research staff education and networking.
Accelerating Solutions for Cell and Gene Therapy Evaluation and Novel Delivery (ASCEND) provides cell and gene therapy trial guidance, resources, and support.
The new Clinical Trials Data Coordination Center will provide support for data management and analysis for multi-site trials.
The new Clinical Trials Training program will train faculty on becoming effective site principal investigators in clinical trials.

For most departments, day-to-day responsibilities remain the same. Investigators and departmental teams continue to:

Develop scientific protocol.
Lead and conduct their studies.
Manage local research staff.

OCT will coordinate:

Departments will have a clearer entry point for trial support.
Start-up processes will become standardized and measurable.
Bottlenecks can be identified and addressed earlier and more consistently.

The goal is to reduce administrative burden over time, not add new layers.

No, the OCT does not remove departmental authority over investigators, staffing, or academic decisions.

The OCT works with:

Departments.
Existing research administration offices.
The Office of the Vice Chancellor for Research and CU Anschutz School of Medicine leadership. ;
UCHealth and partner institutions

Its role is to coordinate and standardize processes—especially for start-up, budgeting, coverage analysis, and system build—so that departments are not navigating these steps alone or inconsistently.

You should reach out to OCT at [email protected] when:

Planning or launching an industry-sponsored clinical trial.
Facing delays or uncertainty during start-up.
Considering participation in a strategic industry partnership.
Developing a complex, multi-site, or cell/gene therapy trial.
Needing help identifying the right support office.

Early engagement typically leads to faster and smoother start-up.

Some centralized fees are under development, primarily related to:

Industry-sponsored clinical trials.
Cell and gene therapy trials (ASCEND).
Strategic industry partnerships.

All fees are being designed to reflect true operating costs, support sustainability, and reduce downstream burden on departments. Detailed guidance will be shared before implementation.