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Introduction: Evaluating and Implementing Clinical Trial/Research Study Imaging Requirements

The Human Imaging Research Office is intended to be the facilitator for clinical trials and research protocols that require radiology and imaging exams for their subjects. In this regard, the HIRO’s goal is to make this process more efficient and accurate and to provide University of Chicago investigators with a wide selection of human research imaging services.

Clinical Trial Imaging

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One of our goals is to ensure that imaging exams (x-ray, CT, MRI, ultrasound, nuclear medicine, etc) for research subjects and clinical trial patients are performed in a manner consistent with the trial's protocol. Clinical trial sponsors will often require that all sites follow specific imaging guidelines, even if trial-related imaging exams are standard-of-care, and they will often forward imaging manuals and materials to principal investigators and coordinators. This includes any specialized imaging sequences or paperwork that must be completed during an exam.

To this end, the HIRO's Image Acquisition Team is responsible for coordinating any issues related to the planning and execution of research-related human imaging at the University of Chicago. This includes protocol preparation and review with the local principal investigator and their team, imaging protocol coordination with clinical and research radiology staff, scan scheduling and billing coordination, resource and data management, and quality assurance. You may utilize these services even if the imaging for your study is considered standard-of-care.

The HIRO can assist you with:

Site SurveysThe completion of site survey forms and questionnaires regarding imaging equipment and capabilities.
PersonnelIdentifying key imaging personnel, including radiologists and technologists, for your study.
Sponsor TrainingArranging sponsor-mandated tele-training sessions with imaging personnel.
Test ScansArranging and performing sponsor-mandated test scans, including scans on calibration devices (also called "phantoms") or human volunteers.
Site VisitsArranging the participation of the Department of Radiology (or other relevant departments or centers) in sponsor site visits where required.
Acquisition GuidelinesSetting up specialized workflows and programming scan parameters.
De-identified Copies of ExamsDe-identifying and submitting copies of trial scans to the sponsor. The HIRO is very familiar with industry-standard image transfer tools like AG Mednet, Ambra (formerly DICOM Grid), BioClinica Smart Portal (formerly MyWebSend), etc.
Transmittal Forms The completion of data transmittal forms and other scan-related paperwork.

Getting Started

If you are in the process of planning or starting a new clinical trial or research study that will require imaging, or if you would like assistance with the imaging required for an on-going study, please contact the HIRO.

For a more detailed description of our services, please see the Services section of our website. You can view the HIRO's Frequently Asked Questions list by clicking here. We have also created a Site Visit Packet/Information Packet that you may find helpful when discussing our imaging capabilities with your trial's sponsor.