We are in the process of developing Sponsor SOPs for Investigator Studies.
These studies will take at multiple locations. Our organization is a non-profit
research organization and is not a covered entity. Sites that we are working
with provide both health care and are involved in research. We are unsure
about our responsibilities as the study sponsor to HIPAA and need some
guidance.

All study procedures required by the protocol are funded so none of the tests
are done standard of care.

The sites are paid per subject visit.

Is the determination regarding covered entity occur at the overall level or can
the determination be made per study?

Any advice that you can provide will be greatly appreciated.

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