Human Research Protection Program

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:

ClinicalTrials.gov Support

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.  

IND/IDE Sponsor-Investigator (SI) Support

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.

This team provides guidance on whether an IND is required; answers questions about the submission process; and assists researchers in complying with the regulatory requirements associated with IND and IDE applications. The ideal time to contact the IND/IDE service is before a research study is ready to move into human trials; consulting with the SI Support team while still in the preclinical phase will ensure that investigators obtain the appropriate data needed for an IND application.
 
In addition to assisting with collecting and compiling documents and submitting applications to the FDA, the SI Support team can help reduce the administrative burden on investigators by maintaining, managing, and monitoring INDs and IDEs; assist with the development of data and safety monitoring plans; assisting with the renewal of applications; and writing and submitting annual progress reports.