A draft clinical trial template tool might help investigators design and submit better protocols.

“It’s a tool for investigators that allows them to prepare protocols for Phase II and Phase III trials in a way that is efficient and will result in timely review,” says Carrie Wolinetz, PhD, associate director for science policy and director of the Office of Science Policy at the National Institutes of Health (NIH) in Bethesda, MD.

The draft protocol template, published March 17, 2016, arose out of discussions between NIH and the FDA. Changes will be made after comments are reviewed, and it could be made final later this year, Wolinetz says.

“We wanted to streamline IRB reviews and help investigators more easily get through the FDA regulatory process,” Wolinetz says.

There’s a high turnover rate in the clinical trial industry, with as many as 85% of investigators who submitted a new drug application in 2007 having only participated in a single clinical trial.1

Standardized templates can help first-time investigators write protocols that can make it through the IRB review process more easily, Wolinetz suggests.

The National Cancer Institute provides a template for studies it funds and its template can serve as one example, but researchers in other fields may not have access to protocol templates, she notes.

This is why there is a great variation in terms of what investigators are submitting to the FDA, and that’s the problem NIH and FDA wanted to solve, Wolinetz says.

The 47-page protocol template suggests the following main sections:

  • key roles, introduction, objectives and purpose,
  • study design and endpoints, study enrollment and withdrawal, study agent, study procedures, and schedule,
  • assessment of safety,
  • clinical monitoring,
  • statistical considerations,
  • source documents and access to source data/documents,
  • quality assurance and quality control,
  • ethics/protection of human subjects,
  • data handling and recordkeeping,
  • study administration,
  • conflict of interest policy, and
  • literature references.

The protocol template provides definitions, sample charts, diagrams, and graphs, as well as explanations and examples.

For example, the template includes a sample flow diagram of a randomized controlled trial. The top box lists activities that are done prior to enrollment, such as obtaining informed consent and screening potential subjects by inclusion and exclusion criteria, as well as obtaining history. Then a triangle represents randomization with one oval for Arm 1 and another oval for Arm 2. Both arms of the study are linked to a box for performing baseline assessments, which links to a box for repeating study intervention, if applicable, and links to two boxes for following up assessments of study endpoints and safety. The last part is a parallelogram for final assessments.

“One thing we are in the process of doing is making an electronic version of this template, which is a PDF,” Wolinetz says. “It could be something easily utilized in submitting and entering information.”

An electronic version would be useful across different systems. For example, NIH-funded investigators could pull up information from their grant applications and use the electronic data to populate some fields of the electronic protocol, she explains.

“We’d love to see interoperability of all these things so investigators won’t have to enter the information over and over again,” Wolinetz says.

The protocol template will be made available at no charge for all Phase II and III investigational drug or device trials, regardless of the trial’s funding source, she adds.

“One thing we’d like to do is think about whether there would be utility in making other templates, as well,” she says. “This is our starting place, and we’ll move from there.”

The draft protocol template is available online at: http://1.usa.gov/1S3t5CG.


  1. Transforming Clinical Research in the United States, Challenges and Opportunities: Workshop Summary. National Academies Press (US). 2010. Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation.