The Office of Clinical Research assists with IDE and IND submissions and with protocol development, generally from inception through the life of the study. The protocol development project manager will assist investigators with development of the protocol and consent documents from concept phase, including facilitating discussion with key institutional players and preparing grantor submission. The IIT regulatory specialist will submit to the FDA for the IDE (or IND) once the protocol is RRC-approved, and will facilitate any correspondence and work with the project manager until the FDA grants approval. The specialist then registers the study with clinicaltrials.gov and CTRP, and will submit any amendments and all continuing reviews to the FDA and the websites until the study is terminated.
To study an investigational device, the sponsor must receive approval from:
- FDA – You must provide FDA with the protocol at the time of IDE application.
- IRB – You must provide IRB with the protocol, an FDA approval letter and a draft consent document at the time of IRB submission.
- CMS – You must provide Medicare with the protocol, an FDA approval letter and IRB approval, plus IRB approved consent and the executed contract with budget at the time of CMS submission.