STEPS TO STUDY ACTIVATION
Submit to Office of Research Imaging (ORI) for Imaging and Radiation Safety Review
Research that involves radiology imaging must be submitted to the Office of Research Imaging (ORI) for review and registration. The office is dedicated to supporting IU School of Medicine and IU Health investigators and their staff through biomedical imaging in research and clinical trials. Registration with the ORI must be done prior to submission to the IRB. Imaging X-ray, IR/Fluoroscopy, Mammogram, CT scan, PET Scan, MRI, Dexa Scan, Ultrasound, Nuclear Medicine, Image-guided Biopsies.
Submission and Start-up Process
Access the online portal for ORI Registration
- The main study protocol and any imaging manuals should be included in the submission.
Review, sign, and send radiation safety application documents provided to you by ORI (if applicable) to radsafe@iu.edu.
- ORI will provide general risk wording that should be included in the informed consent documents.
- Add supplied wording to informed consent. If applicable, send it to the sponsor for approval.
- If the sponsor/IRB request a change in the general risk wording, this will need to be reviewed and approved by the Radiation Safety Office.
- Resubmit consent to Radiation Safety with added language to obtain preliminary approval. Include preliminary approval in your IRB submission.
Forward all imaging questionnaires to ORI for completion. ORI will provide a budget for services, assist with scanner qualification, tech training, and transfer all study images to the central lab, if applicable.
- Provide IRB Approval Letter and IU Account Number or IU Health invoicing information
Schedule a Startup Meeting with ORI prior to scheduling the first patient. Start-up meetings are required for studies with nonstandard imaging protocols. Startup meetings are encouraged for all studies to ensure a smooth and successful study.
Remember to send all protocol amendments to ORI throughout the study.
Important Scheduling Information
- All research imaging exams should be scheduled with ORI. Scheduling specifics and logistics will be provided during the study start-up meeting.
- ORI schedulers will be utilized when the study requires specific research guidelines to be followed.
- Cerner orders must be placed prior to scheduling with a note stating it will be scheduled by ORI.
Resources and Contacts
- For additional information on services, rates, policies, etc. visit the Office of Research Imaging website.
- ORI Registration and Start-up Checklist
- If you have any questions, please email ori@iu.edu.
- Note on Scanners:
- IU Health clinical scanners will import imaging and reports into the Electronic Medical Record (EMR) and IU Health Picture Archiving and Communication System (PACS). Billing will occur through the IU Health Revenue Cycle Services (RCS) billing systems and processes.
- IU Research Scanners (MRI, PET-CT) will import imaging and reports into the research PACS. These visits will not be sent to the EMR. Billing will occur internally, and RCS will not be involved.
IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information
For Cancer Center Trials (studies involving cancer patients):
- If your study needs specialized central reads (such as RECIST reads or other disease assessment reads), please reach out to ORI directly for more information about the RECIST room read scheduling process.
Submit to Office of Research Imaging for Imaging (ORI) and Radiation Safety Review is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.