1ffe Protocol Development | Penn Medicine Clinical Research | Perelman School of Medicine at the University of Pennsylvania

Protocol Development

When conducting clinical research with an industry sponsor or partner, a clinical trial protocol will be provided to you. However, in some cases, you may decide to write your own protocol and serve as the PI and sponsor of a study. These are called investigator-initiated studies.

There are several protocol templates to help you if you choose to write your own protocol:  

  • Clinical Trial template 

  • Social Behavioral template 

  • Humanitarian Use Device template  

  • Retrospective Study template  

  • Observational and Natural History template  

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