The Education and Compliance Support for Human Subject Research (ECS-HSR) aims to protect the rights and safety of research participants and support investigators in the conduct of quality research at the University by providing regulatory education and assistance to the research community.
Provides support to Sponsor-Investigators involved in the development and submission of IND/IDE applications to the FDA.
Provides support for ClinicalTrials.gov submissions, sharing study documents and disclosing data sharing plans.
Provides local monitoring services for clinical studies, RISE Reviews, and educational presentations.
The Good Clinical Practice (GCP) Toolbox contains general guidance and study documentation tools.
Educational presentations are available to enhance the knowledge and application of Good Research Practice (GRP) principles.
Guidance and Formal Application to conduct a clinical trial under sponsor-investigator held IND/IDE at external sites.