Electronic submission process for the irb：yale univer.ppt

Go-Live! Once it is clear that the electronic route is accurate and the potential users are trained, the route can be placed into Production. A good method for “testing” while in Production is to begin routing with a Pilot group first. This may require initial and subsequent refinements to the various components we’ve discussed so far. Keep in mind that as user groups grow, office procedures change, and system enhancements are released, routing should be viewed as a malleable process. Don’t assume that because your routes work now, they will work without tweaking for years on end. Thanks! Adam Schechter, PhD Coordinator for Systems, Compliance, Education Human Research Protection Program Yale University adam.schechter@yale.edu (203) 737-5564 * Adam Schechter, PhD Coordinator: Systems, Compliance, Education Human Research Protection Program Yale University Goals To identify the main elements of the electronic submission process as it applied to the IRB. To demonstrate the process for creating routing maps, business rules, and meta-rules. To show how an institution’s particular business practices can be designed in the Coeus system. To illustrate the Yale experience as an example throughout. Electronic Submission: The Basics The main purpose of electronic routing is to simulate an IRB’s business practice with paper submissions. Routing is the process of electronically moving a protocol submission through the various required review components of an institution. Rules are tests that determine how the submission will be routed. Initial Swimlanes At Yale, the established paper submission process involved not only approval from the HIC, but also approval from other committees and offices external to the HIC. As such, these needed to be incorporated into the electronic routing schema where appropriate: Example: Yale School of Nursing (Draft) Maps Unit Hierarchy Routing is dependent upon a well-structured hierarchy Maps Maps are tied to a unit Each unit can