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Department of Radiology

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Regulatory Resources for C-TRIC Studies


Use the tabs below to help develop the regulatory aspects of imaging studies at C-TRIC.

 
Helpful Links:
  • COMIRB Homepage

  • ​UC Denver Radiation Safety website

  • Duke has a radiation risk consent form "calculator" that is very helpful in assessing the risks of radiation. The site will give consent language based on the radiation data entered into the "calculator"

  • Click here to view a user friendly radiation risk guide 

 

 Timeline:

Begin with Radiation Safety approvals before your initial submission to COMIRB.

Study staff must be up-to-date on Radiation Safety Training. If your study uses the PET/CT or Radiochemistry Lab at C-TRIC, it must be reviewed by one or both of the Radiation Safety oversight committees below:

 

 

CIR - Committee on Ionizing Radiation
  • Reviews and provides oversight over studies involving radioactive drugs or biological product
  • CIR does NOT apply if your study only involves CT imaging exams

 

RDRC - Radioactive Drug Research Committee
  • The Radioactive Drug Research Committee reviews and approves basic science human research studies involving radioactive drug or biological product
  • RDRC does NOT apply if the radiopharmaceutical is under oversight from the FDA through an IND

 

Radiation Safety Forms
  • Access the forms page to get the most up-to-date applications and guidance documents
  •  TIP: Right-click and download the word documents. It is much faster than simply "opening" the document

 

If you are not sure of the radiation compliance needs of your study contact Riad Safadi, the Radiation Safety Officer for the University of Colorado.