Useful Definitions

Standard of Care Imaging
Standard of Care (SOC) imaging refers to imaging exams that would normally occur in the course of the patient’s clinical management.  SOC imaging defines the imaging modality(ies), anatomy imaged, and frequency of exams that would normally occur if thepatient were not a participant in a clinical trial.

Non-Standard of Care Imaging
Imaging which is not standard of care (SOC) includes imaging exams that would not normally be performed if the patient were not a participant in the clinical trial. Non-SOC imaging may refer to an exam not normally performed, an imaging modality not normally utilized, an area of anatomy not normally covered, or an otherwise SOC imaging exam performed at a time or frequency that differs from that of normal SOC.  Repeating examinations that have already occurred in order to comply with protocol specifications of image acquisition or machine type is also considered non-SOC imaging.

Clinical Imaging Personnel
Clinical imaging personnel include receptionists, patients aides, nurses, technologists, and radiologists who staff the clinical imaging centers within UPHS. These personnel provide the array of services required for the operations of a busy in-patient and out-patient imaging center.  While subjects in clinical trials may frequently be seen in the clinical imaging center, clinical imaging personnel are not able to identify these patients as research subjects, and cannot provide specialized protocol-directed services for these patients.

Research Imaging Personnel
Research imaging personnel include imaging technologists who staff the research imaging centers within UPHS.  The research centers do not have ancillary support staff, nor on-call physicians.  The research personnel are equipped to provide research imaging services to patients on clinical studies (include IV placement and contrastadministration), and are fully trained to provide emergency care when necessary duringthe course of research imaging studies.  However, research imaging personnel cannot provide ancillary patient services to study patients.  As such clinical research coordinators are required to provide necessary services to ensure patient access to the research centers.  The CIC can provide coordinators to perform these services in the course of protocol support.

Incidental Findings
Incidental radiology findings are definite or potential radiologic abnormalities incidentally discovered during a radiologist review of an imaging exam performed for other reasons.  Incidental findings are extremely common in medical imaging, and can lead to additional imaging or other laboratory tests, or even biopsy or surgery.  Costs for such follow-up care is usually not covered by the research study budget.  As such, while an incidental radiology findings may possibly benefit a research subject, it may also entail risks and costs to the subject.