Resources for teams who manage human subject research:
- Clinical Material Services Unit (CMSU) provides distribution of investigational drugs, devices and overall supply chain management for multi-center studies and large University studies.
- Investigational Drug Services provides support to research teams regarding supply chain management for local, single-site studies.
- Office of Regulatory Support offers services to support the navigation of and compliance with governing requirements and provides assistance with the development of an informed-consent process through the Research Subject Advocacy (RSA) Program.
- Office of Research & Project Administration (ORPA) provides many resources including:
- University Forms to support continuing education and training for research faculty and staff.
- Clinical Trial Resources to access training for clinical trial finances and Clinical Research/Clinical Trial Policies, Procedures, Forms, Templates, Practice Aids and Standard Operating Procedures.
- Office for Human Subject Protection (OHSP) resources include educational programs to assist researchers in protecting the rights, welfare, and safety of human subjects.
- Complete the Human Subject Research Certification
- OHSP also provides guidance and templates for Protocol, Documents (logs, source documents, notes to file and regulatory files) and Consent Forms.
- Research Subjects Review Board (RSRB) Office manages the University IRB-review processes, whether reviewed within the University or by an outside IRB.
- Log in to Research Subjects Review Board Online Submission System (ROSS).
- Phlebotomy Training Resource for Study Team Members is a for-fee service provided by UR Medicine Lab. This in-person program is designed to orient the study team member to standardized phlebotomy techniques and best practices and to apply knowledge through a structured practicum, which, when successfully completed, will result in the study team member's readiness for performing phlebotomy at the University of Rochester and its affiliates. It is the responsibility of the phlebotomist to meet maintenance requirements (6-month post-orientation and annual training an competency demonstration) per NYS Department of Health regulations.
- Research Subject Recruitment and Retention tools, resources and databases.
- Resources and Services links researchers to relevant resources, tools and collaborators, and assists with required regulatory processes. To request personalized assistance, email ResearchHelp@urmc.rochester.edu.
- UR Connected is a web-based application that connects research coordinators with projects for which expertise is needed.
- URMC Central Lab Services provides clinical laboratory assays and support for researcher studies.