NIH-FDA protocol template for investigators

NIH-FDA protocol template for investigators

On 2.May.2017

The National Institues of Health (NIH) and FDA Joint Leadership Council has issued a final version of the protocol template for clinical trial investigators.

The NIH-FDA protocol template is primarily intended for clinical investigators who are writing protocols for phase 2 and phase 3 NIH-funded studies requiring investigational new drug or investigational device exemption applications.

It could also be helpful to other investigators conducting studies of medical products that are not regulated by FDA.

Importantly, it has also been harmonized with a separate protocol template that was recently developed by the private sector organisation, Transcelerate Biopharma, for industry-sponsored research.

The protocol template with the standard format will:

  • Faciliate protocol review by regulatory authorities and Institutional Review Board/Ethics Committee
  • Ensure compliance with ICH GCP.
  • Support the investigators to prepare protocols that are consistent and well organised.
  • Make the protocol development process more effective and hereby saving money and time.


Link to the final protocol template:

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