The Schema Review Memo, along with the reviewed protocol schema, is required prior to Banner and UA IRB review. The Memo provides documentation of the schema review process by the Principal Investigator and the Epic Charge Validator. If there is no Charge Validator because the study will not utilize Banner services, the Study Coordinator information should be provided instead. A blank Schema Review Memo is provided in this link along with three examples of reviewed protocol schemas.
Retrospective Chart Review projects using HSPP Form F203 do not require submission of this document.
1) Complete the Memo, including the required signatures.
2) Follow the instructions on the Memo to review the Protocol Schema, Schedule of Events, or Calendar of Events. If a schema is not included in your protocol, create a list of the research events in a Word document. Include a statement, "All circled protocol events are research-related and not part of routine care."
3) Circle services that are research-related and not considered routine care (standard of care).
4) The PI and the Epic Charge Validator must print their names, sign, and date the reviewed Schema or Calendar of Events.
4) Upload the Memo and reviewed Schema to the online submission form.