In partnership with the Institutional Review Board, the Office of Clinical Research has developed four protocol templates to assist investigators and research teams in the protocol development process. It is our intention that the use of the templates will provide helpful guidance and reduce the length of time it takes to write investigator initiated protocols. The template can be found on the OCR website in the Forms, Tools and Templates Library under protocol templates: https://www.med.upenn.edu/ocr/secure/forms-tools-templates.html
- Clinical Trial Template: This protocol template is designed to help research teams develop a clinical trial protocol that includes an investigational intervention (drug, biologic, vaccine or device).
- Retrospective Study Template: This protocol template is designed to facilitate the creation of a retrospective clinical research protocol.
- Social Behavioral Study Template: This protocol template is designed to assist in the process of creating a social and behavioral sciences human research protocol.
- Prospective study design with no Investigational Product Template: This protocol template is designed to facilitate the process of developing a clinical research protocol that does not involve an investigational product. E.g. Comparative effectiveness study, a cohort design, case control study, etc.