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Education and Compliance Support for Human Subject Research (ECS-HSR)

The Education and Compliance Support for Human Subject Research (ECS-HSR), a Division within the Office of Research Protections, assists the research community with understanding the federal regulations as they navigate the complex regulatory requirements for conducting clinical research studies. 

Our experienced research professionals facilitate the submission and maintenance of investigational drug and device applications to the FDA, clinical study disclosure activities (including submission to ClinicalTrials.gov), local monitoring services for clinical studies, and the application of Good Clinical Research Practices.  

The ECS-HSR Division also supports the bio-medical and psycho-social research community with educational presentations, training, and Research Investigator Startup Education (RISE) reviews

We hope you will have an opportunity to get to know us, our professional staff is available to assist investigators and their research teams with the following support services.

IND & IDE Support

Provides support to Sponsor-Investigators involved in the development and submission of IND/IDE applications to the FDA and the conduct of clinical studies under such FDA-accepted applications and exemptions.

Clinical Trial Registration & Transparency Support

Provides training and resources concerning disclosure of information, documents, and data for clinical studies initiated by University Investigators. This includes submitting and maintaining clinical study registration and summary results information on ClinicalTrials.gov, disclosing study documents, and plans for sharing (de-identified) individual participant data for further research. 

Monitoring & Compliance Support

Provides local monitoring services for clinical studies, Research Investigator Startup Education (RISE) Reviews, educational presentations and source documentation templates to support the research community.