Protocol Templates and Forms

This page includes seven different protocol templates for developing a variety of different new research protocols.  None of the templates are likely to be perfect for a given study without some modification. It is expected that the investigator will adapt the template to suit their needs. Sections that are not applicable should be marked as not applicable and if necessary, additional sections may need to be added.

• 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. 
• Additional Protocol Guidance

Interventional Research Protocol Templates

Observational Research Protocol Templates

Guidance/Guidelines

Additional Protocol Guidance