Regulatory Support Office
The Regulatory Support Office (RSO) of the Human Research Protection Program (HRPP) provides assistance to investigators and study teams with navigating complex regulatory requirements.
Targeted support is available to investigators with the following:
The RSO's ClinicalTrials.gov (CT.gov) team offers support to research teams with navigating and complying with the complex requirements of ClinicalTrials.gov. ClinicalTrials.gov is a database of clinical research trials conducted in the United States and around the world.
The RSO provides guidance in determining whether a clinical trial must be registered, who is responsible for the registration, when the registration must be updated, and whether study results must be reported. In addition, the RSO will assist with understanding the deadlines and requirements for registration, updates, and results reporting.
The RSO's SI Support team provides a comprehensive, centralized resource for FDA submission of Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs), with staff members who provide full IND/IDE support.