Site qualification serves as a precursor to trial-specific credentialing through the establishment of contacts between IROC QA Centers and personnel at the participating research sites. Processes are developed with an emphasis on minimizing administrative burden. For example, a comprehensive database of facility-specific information, such as key personnel, imaging and radiotherapy (RT) equipment, and qualification steps completed, serves to track site qualification status efficiently. A Web-based “Facility Questionnaire” will facilitate capturing information for new sites and obtaining updates for existing sites.
IROC qualifies the full range of imaging and radiation oncology modalities at sites participating in NCI-sponsored research to ensure that each has the basic resources and capabilities needed for successful clinical trial participation. Through the site qualification process, incompatibilities in imaging or RT equipment performance or calibration will be identified and corrected before a site opens a trial with specific imaging or RT requirements.
Imaging Site Qualification Components
These may include:
- Basic cross-sectional modalities
- Advanced imaging morphologic, functional, and molecular techniques
RT Site Qualification Components
These may include:
- Web-based verification of a site’s reference beam output
- On-site and Web-based treatment planning dosimetry data verification
- Approval of proton radiation therapy centers for participation in NCI-funded trials