Steps For New Investigators
Getting Started on Your Clinical Research Trial
In order to conduct clinical research at URMC new investigators must complete the following steps. The PCRO can assist with many aspects of this process.
1. Ethics Certification
All investigators require ethics certification before conducting clinical research at URMC. Depending on the nature of the research, either an Ethical Principles in Research Practice (EPRP) or, a Human Subjects Protection Program (HSPP) certification is required.
Certification requires reading, “Protecting Study Volunteers, A Manual for Investigative Sites,” which can be obtained from the Office for Human Subject Protection (OHSP), and passing a 52 question exam.
Contact: Bill Kelvie, Director, Research Education - Office for Human Subject Protection
2. Apply for an Account in the ROSS Submission System
After an investigator has obtained either EPRP or HSPP certification, they can request an account in the ROSS submission system which will allow submission of new studies and for the on-going regulatory maintenance of existing studies.
Complete an application with the RSRB for an on-line account in the ROSS submission system by visiting the Office for Human Subject Protection (OHSP).
3. Complete the Clinical Trial Billing Compliance Course
Investigators are required to complete the on-line Clinical Trial Billing Compliance Course per University policy.
Contact: Michael Ritz, Research Compliance Officer
Role of the Pediatric Clinical Research Office (PCRO)
The Pediatric Clinical Research Office (PCRO) is a valuable resource to pediatric investigators and can provide assistance with the following:
Scientific review of all studies either prior to Research Subjects Review Board (RSRB) submission or, as part of the RSRB Application and departmental sign-off process
RSRB preparation and submission
Budget development and negotiation for sponsored clinical trials
Mentorship for investigators and/or study coordination staff
Study Coordinator - If an investigator has the funding to support a Study Coordinator, the PCRO can assist with: writing a job description, screening applicants and participating in the interview process.
Contact: Nicholas L. Ferraio, M.S., M.P.A.
Director, Operations & Regulatory Affairs