PRESENTED BY: Cherron Payne, Esq., Office of

Transcript:PRESENTED BY: Cherron Payne, Esq., Office of:
PRESENTED BY: Cherron Payne, Esq., Office of Clinical and Translational Research Dowling North, Second Floor Ext. 2037 chpayne@uchc.edu CONTRACT PROCEDURE AND NEGOTIATION FOR CLINICAL TRIALS AT THE UNIVERSITY OF CONNECTICUT HEALTH CENTER INTRODUCTION TO THE ROLE OF CONTRACTS IN CLINICAL TRIALS The administration of a clinical trial commences in the Office of Clinical and Translational Research “OCTR” Contract negotiation is the first step in the administration of a clinical trial THE OFFICE OF CLINICAL AND TRANSLATIONAL RESEARCH “OCTR” The role of OCTR is to ensure research, financial, and legal compliance in the administration of clinical trials at the University of Connecticut Health Center “UCHC” OCTR CONSISTS OF THE FOLLOWING POSITIONS: Executive Administrator Administrative and Clinical Research Coordinator Reimbursement Analyst Administrative Fiscal Assistant Contract Specialist EXECUTIVE ADMINISTRATOR: Judi Kulko, MS, MSN Oversees the management of the OCTR Ensures that clinical trials are in compliance with federal law and UCHC policy ADMINISTRATIVE AND CLINICAL RESEARCH COORDINATOR: Judy Kulakofsky Analyzes and negotiates the budgets for clinical trials Completes budget workbooks for each clinical trial (medical and/or dental) that has JDH, UMG and/or dental charges Completes Medicare review relevant to payment for clinical trials REIMBURSEMENT ANALYST: BARBARA JONES Manages the “Banner” accounts Reconciles accounts after first subject is accrued Conducts audits of research accounts Reconciles the account at time of account closure ADMINISTRATIVE FISCAL ASSISTANT: DIANE CLAVETTE Provides administrative support to the OCTR Issues case numbers for clinical trials subjects CONTRACT SPECIALIST: ATTORNEY CHERRON PAYNE Reviews the clinical trial contract Revises contract language Drafts and/or proposes new contract language Negotiates proposed contract revisions with the sponsor or clinical research organization “CRO” Seeks opinion from the Assistant Attorney General (if necessary) Confirms budget approval with the Administrative and Clinical Research Coordinator Obtains necessary signatures CONTRACT SPECIALIST Contract Specialist in the OCTR negotiates ALL clinical trial contracts except: Investigator-Initiated Federally-Funded Clinical Trial Contracts Investigator-Initiated Federally Funded Clinical Trial Contracts are negotiated by the Office of Research and Sponsored Programs “ORSP” CONFIDENTIALITY AGREEMENTS Confidentiality Disclosure Agreement “CDA” (or Non-Disclosure Agreement “NDA”) is a contract designed to protect information that is confidential or proprietary. CDA The CDA is sent to the Principal Investigator/Study Coordinator in order for the sponsor to protect its confidential information such as trade secrets, patents, drawings, etc. If a PI receives a CDA, the contract should be forwarded to the Contract Specialist in the OCTR for negotiation CDA The CDA is a precursor to