This new clinical trial template (See IRB Toolkit for Investigators) will assist NIH-funded investigators with preparing protocols conducted under Food and Drug Administration’s Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application. This tool will help both IRBs and the FDA perform speedy reviews. NIH has also released a web-based Electronic Protocol Writing Tool that investigators can use to form a “protocol writing team” composed of different individuals to write and review documents. Call Research Protection Programs at x44531 if you have any questions.
July 5, 2017
IRB: New Protocol Template for NIH-FDA Phase 2 and 3 IND/IDE Clinical Trials
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