Regulatory Applications

Regulatory Submissions for Sites

It is the responsibility of the Site PI to submit the protocol and all accompanying documentation to the IRB and any other required entities for review. For all information regarding submissions, including what needs to be submitted, IRB forms, review or submission support, and IRB fees for certain studies, visit the Penn IRB website.

For some studies, an individual might be both the PI and the (Regulatory) Sponsor. In this case, both sets of responsibilities mentioned apply.

Regulatory Submissions for Sponsors

1. US Trial

Sponsors who are developing investigator-initiated protocols should follow the steps outlined here for studies to be conducted in the US.

2. International Trial

If you are conducting clinical trials outside of the US, trial requirements will differ by country. Reference Step 4 and contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.

For some studies, an individual might be both the PI and the (Regulatory) Sponsor. In this case, both sets of responsibilities mentioned apply.