Support Diagnostic Radiology Research at City of Hope

At City of Hope^®, we are passionately committed to transforming patient care — not in the distant future, but right now. As a leading hub for clinical trials and diagnostic imaging innovation, our mission is to bring leading-edge treatments and technologies directly to those who need them. 

Each year, we conduct over 730 clinical trials, enrolling more than 5,000 patients across a broad range of therapeutic areas. Our robust trial portfolio reflects a dedication to speed, precision and accessibility, making us a recognized leader in clinical research on a global scale. 

Our diagnostic radiology research team collaborates extensively with clinical investigators to support and enhance research across the City of Hope. We offer ancillary services for:

• Industry-sponsored trials
• Cooperative group studies
• Investigator-initiated protocols

Our capabilities span from conventional radiography to advanced modalities, including computed tomography, magnetic resonance imaging, X-ray, nuclear medicine and ultrasound, ensuring high-quality imaging support for both routine and complex trial designs.

Protocol Review Workflow for Radiology-Related Protocols Pre-Endorsement

*Please note, if we receive protocols after endorsement, the study team risks radiology being unable to provide the requested services.

Site Qualification - Prior to Endorsement

The PI, sponsor or funding entity will provide relevant study materials to the Systems Clinical Trials Office, which should include the COH Feasibility Form, a synopsis, proof of concept, site qualification questionnaires, imaging acquisition guidelines (if available) and the full protocol.

Upon receipt, the diagnostic radiology research team will perform an initial evaluation of the proposed procedures to determine which is considered standard of care (SOC) and which is not. If all procedures are deemed SOC, no further radiology review will be necessary. If any procedures are identified as non-SOC, a full protocol review will be initiated. The initial assessment will be completed within 3 to 5 business days.

Full Protocol Review Process (Pre-endorsement)

If required, the full protocol review will assess the following components: equipment and imaging requirements, physicist involvement, calibration needs, phantom or volunteer scans, radiologist time and effort, pharmaceutical use, interventional radiology (IR) procedures, and technologist time.

Initiation of Full Review (Pre-endorsement)

Following the initial assessment by the Radiology Research Office, the full protocol review will include the following components for non-standard of care (non-SOC) procedures:

• Research procedures: Detailed outline of all non-SOC procedures specified in the protocol.
• Personnel training: Identification of training needs for research assistants, nurses, technologists, and clinical research coordinators.
• Radiologist requirements: Evaluation of radiologist training and support needs.
• Resource availability: Assessment of required resources, including but not limited to technologists, nursing staff, physicists, clinical research coordinators and radiopharmacy support.

Imaging Manager Review (Pre-endorsement)

Imaging managers per modality will evaluate the feasibility of supporting the study based on:

• Equipment availability
• Imaging requirements (e.g., new, additional or routine sequences)
• Technologist availability
• Departmental capacity

If support is feasible, the protocol will proceed to the next level of review.

Section Chief Review (Pre-endorsement)

If needed, Section chiefs will conduct a final evaluation to determine whether the department can fully support the study. If approved, the protocol will move forward to the endorsement phase. If not, the study will not proceed. Additional review may be required depending on the complexity of the protocol. Radiologists' assignment to trials is dependent upon departmental review and approval and based on availability, capacity to support, coverage logistics, and allocated time and effort.

Site Selection Phase

If the study progresses to the site selection stage: 

• Feasibility questionnaires must be completed and submitted for endorsement.
• Any required imaging and equipment-specific questionnaires will be filled out and returned to the sponsor.
• The full protocol review will also include completion of the following:
  • City of Hope (COH) Feasibility Form (Radiology section thoroughly filled out)
  • Radiology Resource Assessment (to be included in the COH Feasibility Form)

Endorsement

During the endorsement phase, Clinical Trials Support Services (CTSS) will prepare a draft budget. The research team will include a Radiology Resource Assessment for CTSS consideration as the budgets are drafted. A budget review meeting will then be scheduled with the principal investigator, radiology research manager, and radiology division administrator.

The team will be notified once the study contract has been fully executed before the Site Initiation Visit.

Site Initiation Visit and Study Activation

Following contract execution:

• The approved budget and chart string will be issued to the Radiology department before study activation and final radiology approval.

Radiology Approval Memo

A formal Radiology Approval Memo will be distributed to the following stakeholders:

• Principal investigator
• Disease team
• Imaging managers
• Research finance team
• Radiology scheduling
• IT team
• Radiologists

This memo serves as official documentation of radiology approval and readiness to support the study.

Clinical Trial Billing Workflow

Budget Proposal 

• The Budget Administrator submits a proposed budget to the Diagnostic Radiology team.
• Radiology personnel will review the imaging requirements and provide finalized measurements if needed.
• Imaging services begin once designated radiologists perform trial procedures.

Study Endorsement

• Radiology services and cost analysis are included in budget discussions.
• All stakeholders agree on what constitutes standard-of-care versus non-standard procedures.
• Upon review by the imaging manager and the section chief, the study is endorsed by the radiologist voting member. 

Final Budget Distribution

• The approved budget is shared with the section chief, principal investigator, or sub-investigator before the Site Initiation Visit.
• This ensures all imaging-related costs are accurately documented and approved by both the institution and sponsor.

Budgeting Policies

Timely Protocol Review

• Radiology reviews any clinical trial that includes imaging procedures in its schedule.
• A response is provided to Clinical Trials Support Services within five business days, containing:
  • CPT codes for required imaging
  • Fees for startup and non-imaging tasks (phantom scans, CD creation, image transfers)
  • Time and effort costs for non-standard assessments

RECIST or Tumor Measurement

• Radiology confirms protocol-defined time points for reads based on RECIST or similar criteria
• A flat rate of $100 per occurrence applies across all trials

Reading Rates

Radiology Startup Fee Policy

Radiology does not receive reimbursement for startup services for trials that are:

• Internally initiated and funded at City of Hope
• Cooperative group or nationally funded

For other trials, a $1,000 startup fee applies (new fee proposed). CTSS will incorporate this fee into sponsor-facing budget communications, provided Radiology identified it during initial review.

If a sponsor declines reimbursement for these services, CTSS will remove the cost and notify Radiology that payment is not expected.

Site Initiation Visit and Study Activation

• Radiology must be notified once a trial contract has been executed.
• If the contract is not finalized by the Site Initiation Visit, a valid cost center or contract must be submitted before the trial opens for accrual.