The University of Arizona Health Sciences Center requires source documentation that shows details for all required study procedures and a determination of whom is paying for activities, upfront and before the clinical trial starts. The basis for this requirement is to complete a Payor Coverage Analysis and use the designation of procedures to ensure that the informed consent, external budget/billing grid, and clinical care expenses related to an active study all concur to this assessment.
A completed Schedule of Events Review Memo and Reviewed Schema are required to be submitted through our online Research Intake Form prior to Banner and UA IRB review.
- Schedule of Events Review Memo: The cover memo for the Principal Investigator (PI) Reviewed Schedule of Events explains how to differentiate between conventional (routine) care and research-related items. It also documents other budgetary information, such as any facility fees, professional fees, subject compensation, etc.
- Schedule of Events or Schema: A list or table of the sequence of protocol-specified events. This is generally included in the study protocol.
- Reviewed Schedule of Events: The Schedule of Events (Schema) in which the PI has designated services as either: 1) Medically necessary (conventional/routine care) that are part of subject's care regardless of his or her participation in a clinical trial; or 2) Research related that are only done as part of subject's participation in the clinical trial.
The original completed Reviewed Schedule of Events is to be stored and maintained by the PI.
Who completes the schedule of events review?
- Only the PI is authorized to complete, sign, and date the schedule of events
Reading a reviewed schedule of events
- CIRCLED items - to be paid for by the Sponsor because they are research-related.
- UNCIRCLED items - determined by the PI to be medically necessary (i.e. conventional care/routine) and billable to insurance.
Note: Retrospective chart review projects using HSPP Form 203 do not require submission of a schedule of events.
- Complete the memo, including required signatures.
- Follow the instructions on the memo to review the Protocol 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.
- Circle services that are research-related and not considered conventional care or medically necessary (standard of care).
- The PI must print their names, sign, and date the reviewed Schedule of Events.
- Upload the Memo and completed/reviewed Schedule of Events to the online Research Intake Form.