This checklist describes the elements that must be included in a protocol submitted to WIC. Protocols that do not address the elements will be returned to the study team for revision.
Please note the following: *WIC will accept protocols that us a different format ONLY if they address the elements within the checklist. A project summary may be substituted for a formal protocol for studies that will not be enrolling subjects at any WIC site (e.g., chart reviews, specimen analysis). A project summary may be brief and should describe what study activities will be conducted at each site and who will be involved in conducting those activities at each site. The project summary must provide sufficient detail for the involved IRBs to determine whether deferral of IRB oversight to a single IRB is appropriate.