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    • Other subject statuses, specifically withdrawn, not eligible, and off study, were entered in OnCore within one day of occurrence.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