High-Quality Imaging and Site Compliance
During study start-up, we verify that each site can reliably support the imaging requirements of the trial. We assess retrospective imaging collected per site standard-of-care (SOC) protocols and/or review completed screening questionnaires regarding each site’s capabilities. Our goal is to identify sites that may be unable to consistently acquire and transfer high-quality imaging to MMI for further processing.
After screening, our experienced technical staff will train sites on the image acquisition and transfer requirements, including the Image Acquisition Protocol (IAP) and Image Transfer Protocol (ITP). Depending on the scope and complexity of the trial, we will administer the training via web conferencing, delivery of electronic content for self-paced review, and/or onsite instruction.
Our site training program includes:
- Distributing the IAP, ITP, and support material in professional site training kits.
- Scheduling training sessions with enough lead time to assure attendance by all required personnel.
- Emphasizing similarities and differences in the image acquisition requirements relative to SOC protocols.
- Providing practical tips and guidance on best practices for IAP compliance.
- Discussing the purpose and use of specialized calibration and positioning devices, when applicable.
- Training on QA phantom setup, scan acquisition, and QA scan analysis, as needed.
- Performing uploads of test images to check for IT constraints and proper transfer.
- Collecting test images of phantoms or volunteers for QA reviews, if appropriate.
- Providing site feedback on acquisition technique, when indicated.
- Verifying the effectiveness of training and creating a site training record.
Site Compliance Monitoring and Maintenance
After training, we monitor sites for ongoing compliance to the IAP and ITP. As images are received, we promptly notify sites of discrepancies in image labeling and quality. Corrective actions are proposed when appropriate. All queries are electronically documented and tracked to assure timely follow-up and close-out. Cumulative discrepancy reports may also be generated to identify sites with systematic deviations requiring further training.