Protocol Development Principal Investigators of accepted Full Applications are assigned a Protocol Development Team, consisting of ITN staff - a Medical Monitor, Clinical Project Manager, Medical Writer, Biostatistician, Tolerance Assay Project Manager and others. This team assists the investigators with planning the study, coordinating sites, writing the protocol, navigating regulatory issues and more. The ITN aims for quick turnaround on all new projects forwarded to protocol development. However, applicants should note that occasionally, the number of incoming studies can overwhelm ITN resources, in which case protocol development will be prioritized among all new studies. |