All changes will require IRB approval prior to the implementation of the change, unless the requested change is necessary to reduce immediate risks to human subjects. Amendment to Protocol, ICF, Investigator Brochure Miscellaneous Research Submission Form Report of an Unanticipated Problem Unanticipated problems must be reported within 5 days of site becoming aware of them If reporting an SAE please complete an SAE Report Form and submit with this report If filing a protocol deviation, a Protocol Deviation Form must be submitted SAE Reporting Form All SAEs must be reported to MWMC within 48 hours of site becoming aware of them Protocol Deviation Form IND Safety Report Additional Research Location Form Change to Investigative Site or Staff