If you’re an investigator who writes your own IND or IDE protocols — or you work with an investigator who does — here’s a new resource you’ll want to note. The NIH and FDA have jointly released a protocol template for phase 2 and 3 IND/IDE clinical trials.
The link above takes you to a news release that will guide you to the template, and also to a secure, web-based e-protocol writing tool allowing investigators to generate a new protocol using the template. Per the news release, the protocol writing tool will allow several writers and reviewers “to participate in the protocol development process.” We strongly encourage you to click around to see if this is something your team could use.