Office of Regulatory Support

ORS offers services to support investigators with the navigation of and compliance with a range of governing requirements. In addition to general assistance with requirements as they arise, expertise is provided to support specific FDA-regulated processes, including research involving experimental drugs and devices, as well as pre-clinical laboratory studies.

                 Investigational Drugs

Guidance for FDA IND

                  Regulatory Science

Research and Education

            Informed Consent Process

See Available Support

                   Preclinical Studies

Guidance for FDA GLP

                Investigational Devices

Guidance for FDA IDE

                     ClinicalTrials.gov

Guidance for Required Reporting

           Data and Safety Monitoring

Support for Plan Development

                           Training

Requirements for FDA Regulatory Sponsors

Click here to email the Research Help Desk                    Click here to Request a Consultation

 

NIH Funding Acknowledgement ** Important ** All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH FUNDING ACKNOWLEDGEMENT and must comply with the NIH Public Access Policy.