Regulatory Knowledge & Support

Navigation of the regulatory requirements for study approval can be complicated. At the University-level alone, required research oversight reviews can include multiple institutional offices (e.g. HRPO, IACUC, Conflict of Interest, IND/IDE). The CTSI Regulatory Knowledge and Support Core helps facilitate regulatory compliance and promotes good clinical practice in research by providing study teams with proactive regulatory guidance. CTSI Research Facilitators work directly with researchers in collaboration with regulatory agencies to navigate all necessary regulatory pathways, at any stage of their research. They provide personalized education, training, services, and resources for investigators, students, fellows, research staff, and health professionals.

Regulatory Knowledge & Support Services

CTSI Research Facilitators provide assistance with:

  • Grant applications
  • HRPO/IRB process
  • PittPRO pre-submission review
  • Consent form development
  • Institutional Data & Safety Monitoring Boards (IDSMBs)
  • IACUC submissions
  • Quality Assurance/Quality Improvement (QA/QI) projects

Team & Contact Info

Shannon Valenti

Co-director, Regulatory Knowledge and Support
Phone: 412-648-4252

Laurel Yasko

Co-director, Regulatory Knowledge and Support
Phone: 412-383-0749