The Regulatory Knowledge and Support Core of the Clinical and Translational Science Institute (CTSI) promotes good clinical practice and facilitates regulatory compliance in clinical and translational research. CTSI provides hands-on education, training, services, and resources for researchers, students, fellows, research staff, and health professionals.
CTSI works directly with researchers in collaboration with regulatory agencies to navigate all necessary regulatory pathways, at any stage of their research.
HRPO Submission Assistance:
CTSI assists with the HRPO application through OSIRIS (Online Submission for Institutional Reviews) for exempt, expedited and full board studies. CTSI may also assist researchers in the submission of applications to other levels of regulatory oversight.
IACUC Submission Assistance:
CTSI aids investigators in the submission of clinical research proposals involving animal models to IACUC. CTSI can provide guidance to investigators to ensure that their animal programs satisfy standards for appropriate care, use, and humane treatment of animals used for research.
The University of Pittsburgh Office for Investigator-Sponsored IND and IDE Support (O3IS):
Office of Clinical Research, Health Sciences and the Research Conduct and Compliance Office provides assistance to University researchers involved in the development and submission of investigator-sponsored Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs) for acceptance by the U.S. Food and Drug Administration (FDA) and the conduct of clinical research studies under such FDA-accepted applications and exemptions.
For more information or to schedule a consultation contact a Research Facilitator.