What are the IRB Submission Requirements for Treatment Use Investigational Devices?
For Quorum, a treatment use investigational medical device protocol is either submitted as a central study (if submitted by the sponsor) or as a single site study (if submitted by the investigator). The submission forms will depend on the type of submission.
Please contact our Initial Study Support department for more information on submission requirements or access to our Regulatory Attorney Team. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.