Site Qualification & Training

MMI verifies the ability of each potential study site to support the imaging requirements of the trial. Based on the study-specific imaging protocol, we comprehensively evaluate each site’s imaging equipment, infrastructure, and personnel to verify that the site can reliably acquire the required imaging and ensure smooth transfer of images to our facility for centralized review. We provide detailed guidance and hands-on training to guarantee the highest level of image quality and processing. All training materials are comprehensive, user-friendly, and professional.

Our procedures for site qualification and training include:

• Comprehensive equipment testing and calibration.
• Detailed inspection and verification of the acquisition and storage systems.
• Distribution of the study-specific imaging protocol and verification of receipt.
• Didactic training on the imaging protocol and frequently asked questions.
• Evaluation and verification of test images produced per the imaging protocol.
• Development of site-specific and/or equipment-specific quality assurance (QA) procedures, including procedures for daily, weekly and monthly quality control and inspection.
• Instruction on QA phantom setup, scan acquisition, and analysis of QA scans.
• Distribution of printed materials and supplies with instructions for use.
• Verification of image transfer procedures and data query process.

Compliance Monitoring and Site Maintenance

Following initial site training, we perform ongoing monitoring to ensure compliance with the imaging protocol. Each shipment of images is carefully inspected for adherence to documented standards for subject preparation, image acquisition, image quality, image labeling, transfer, management, and completion of transmittal information. Where appropriate, sites are promptly notified of protocol deviations and corrective action is implemented. As needed, we travel to sites to verify equipment calibration, processes, and training. Additionally, we provide on-demand technical and logistical support for study-related questions.

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