Home
Proposal
Information
Sponsor Forms
& Applications
eRA:
Electronic
Research Administration
Continuing
Education
& Training
Office of Research and Project Administration
Industry Sponsored
Clinical Trials
Industry Sponsored Clinical Trials
The following documents have been made available to researchers and staff who conduct or administer industry funded clinical trials.
Clinical Trial Guidelines, Procedures, and Policies
-
Institutional Review of Investigator Initiated Externally Sponsored Clinical Trial Agreements (flowchart)
-
ORPA Guide PDF (Guidance for University Approval of Sponsored Clinical Trials)
- RSRB fee schedule (4/08)
- Office
of Research Accounting and Costing Standards Non-Federal
Clinical Trial Close Out Procedure - Incentive Payments in Clinical Trials (9/2002)
- Compensation for Injury (Provost's memo dated 1/29/08)
- UR
Institutional Risk Assessment Process for Principal Investigator
Initiated Externally Sponsored Clinical Studies - Other Support Information for Grant Applications (memo dated 5/27/03)
- Clinical Trial Registration Prior to Study Enrollment and Manuscript Publication (Individual UR clinical departments may have formulated additional guidance on clinical trial registration.)
- Policy on Support for Registration of Clinical Trials (link to URMC intranet site)
- Subject Payments Policy
Clinical Trial Forms
- University of Rochester Proposal Sign-Off - Industry-Sponsored Clinical Trials (includes Research Profile)
- Standard Clinical Trial Agreement
- sample
Proposal Development
- Basic Guidelines for Investigators (link to OHSP)
