Clinical Research Support Office (CRSO)

University Wide Standard Operating Procedures (SOPs)

The Clinical Research Support Office (CRSO) supports investigators and research teams in departments, centers, and colleges across campus to conduct clinical research. The office aims to reduce administrative burdens, develop a “one-stop” experience that offers efficient, affordable support for all faculty, enhances compliance, and removes barriers to enable efficiency, collaboration, cost recovery, and growth of clinical trials at the university. Operate according to common standards, practices, and policies across the University that minimizes duplication and maximizes value.

IND/IDE Support

Provides high-level expertise, guidance, and support to investigators, reviewing, developing, and submitting applications to the FDA to support sponsor-investigator INDs and IDEs.

Monitoring and QA

Provides independent monitoring support & QA guidance to for investigators and study teams, and to ensure studies are conducted in compliance with the protocol, ICH-GCP guidelines, and applicable Federal, State, and University policies and procedures.

CTSI Liaison Team

Serves as the front-line of a multidisciplinary team which leads scientific, training, and implementation aspects of the Trial Innovation Network.

OnCore

OnCore CTMS (along with its imbedded modules: Insights, eReg, Payments, and EDC) will provide a centralized electronic infrastructure to support the management of budgets, study participants, financial processes, and regulatory documentation. In addition, it will enhance research billing capabilities, transparency and planning opportunities.