More about the audit process
The audit process will include confirmation of the following key elements:
- The study was registered in OnCore and submitted for coverage analysis as required;
- Applicable protocol amendment documents were provided to the Office of Clinical Research (OCR) for the purposes of study calendar and billing grid updates;
- Unit and OCR sign off were completed prior to enrollment of the first subject;
- Subjects were registered in OnCore as consented within one day of consent being obtained;
- Subject visit dates were accurately recorded on the OnCore protocol calendar within one day of visit occurrence; and
- Other subject statuses, specifically withdrawn, not eligible, and off study, were entered in OnCore within one day of occurrence.
Only studies that are subject to the OCR/IU Health research billing policies, and for which initial IRB approval was granted December 1, 2020 or later, will be reviewed for compliance