Step 4: Sponsor Registration
If it has been determined that your clinical trial requires an IND or IDE application, or an international clinical trial application, please complete the Sponsor Registration Survey, as indicated in PSOM SOP006.
Additionally, many trials will require posting on ClinicalTrials.gov. Please reference additional guidance here.
For further guidance, please contact OCR Regulatory via email at psom-ind-ide@pobox.upenn.edu.