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  • Interventional Research
    • There are two templates to be used for interventional research: the Interventional Drug/Device Trial template and the Behavioral and Social Science Research Template both follow the format of the NIH/FDA template and are ICH GCP compliant.  
  • Observational Research
    • There are three templates to be used for observational research: the Natural History/Observational Protocol template, the Repository Protocol template, and the Secondary Research Protocol template.
  • Exempt Research
    • There are two templates (and accompanying instructions for each) to be used for exempt research, one for prospective data collection and the second for retrospective data collection/biospecimen review. 
  • There is a template for the Study Personnel Page.
  • Additional Protocol Guidance

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