If a study will be conducted at multiple sites, the IRB-HSR requires a common protocol that is used by all sites. A common protocol is required even if the overall PI is not from UVa. If a common protocol does not exist, templates for a common protocol found on the IRB-HSR Website at http://www.virginia.edu/vpr/irb/hsr/writingassistance.html may be used. Templates exist for different types of studies such as a minimal risk study requiring expedited review, a study with more than minimal risk requiring full board review. Templates are also available for studies involving an investigational drug, device or biologic.
In addition, if the protocol requires full board review, the protocol must also be submitted to the School of Medicine Clinical Trials office for their review.