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 the clinical trial, but it does not ensure

that a clinical trial will open (commencement of a clinical trial is determined by the clinical trial agreement)

The CDA does not have to be reviewed by the contract specialist, but it is HIGHLY recommended.

If the CDA is not reviewed by the contract specialist, then UCHC will not support the PI if there is any ensuing liability.

The CDA needs to be signed by an approved representative of UCHC to receive support from the Institution.

CLINICAL TRIAL AGREEMENTSThe clinical trial agreement sets forth all of the

applicable terms and conditions for a clinical trial.

Types of Clinical Trial Contracts:Clinical Trial Agreement (CTA) SubcontractsUniversity to University AgreementsAmendments

CLINICAL TRIAL CONTRACTS

Types of Clinical Trial Contracts:

A Clinical Trial Agreement (CTA) or Clinical Study Agreement (CSA) is a direct agreement between the sponsor or the CRO and it establishes the terms and conditions of the clinical trial.

A Subcontract is an agreement between a party to an original contract and a third party (i.e. UCHC has a contract with an entity and that entity has a primary agreement with a sponsor).

CLINICAL TRIAL CONTRACTS

A University to University Agreement is a subcontract with another university.

An Amendment is a document that alters an existing contract (i.e. extends the study, changes the payment information).

GENERAL COMPONENTS OF A CLINICAL TRIAL CONTRACTThe contract generally establishes the following:

Scope of Work (i.e. protocol) * Budget and Payment Information* Termination* Publication* Confidentiality* Liability Indemnification Debarment Intellectual Property* Subject Injury AAHRPP (Accreditation of Human Research Protection Programs)

*Areas to be reviewed by the Principal Investigator/Study Coordinator

STATE OF CONNECTICUT CONTRACT LANGUAGE UCHC is an agency of the state of Connecticut.

Therefore, the following provisions must be addressed in every industry -sponsored clinical trial contract with the state of Connecticut:

Indemnification- Because UCHC is a state entity, it cannot indemnify.

Arbitration or Alternative Dispute Resolution (ADR)- UCHC cannot agree to binding arbitration.

STATE OF CONNECTICUT CONTRACT LANGUAGE

 Governing Law: The governing law for all agreements must be Connecticut law. If the sponsor cannot accept Connecticut law, then the parties will remain silent regarding governing law.

Claims Against the State: The sole and exclusive means for the presentation of any claim against the state of Connecticut shall be in accordance with Chapter 53 of the Connecticut General Statutes.

Insurance: UCHC is self-insured and cannot agree to insurance under a private policy.

CONTRACT LANGUAGE MANDATED BY UCHC AND THE INSTITUTIONAL REVIEW BOARD “IRB”

Subject Injury: There must be subject injury language in all industry-sponsored agreements. Subject injury language addresses reimbursement for a subject that is injured during a clinical trial. Exceptions are made for phase IV clinical trials and registry agreements. The subject injury language in the CTA must be congruent with the language in the Protocol and the patient consent form.

CONTRACT LANGUAGE MANDATED BY UCHC AND THE INSTITUTIONAL REVIEW BOARD “IRB”

Medicare Second Payer Rule: Medicare does not render payment for expenses related to subject injury if the payment has already been made or can reasonably be made by various primary sources, such as private insurance.

CONTRACT LANGUAGE MANDATED BY UCHC AND IRB The Association for the Accreditation of Human

Research Protection (AAHRPP): This language must be in all clinical trial agreements since UCHC is an AAHRPP-accredited institution. The language must indicate that the sponsor will render proper notice to the UCHC regarding any findings that may affect the safety and welfare of the study subjects even after the study ends. It also states that the sponsor will comply with its Data Safety Monitoring Board (DSMB) and render DSMB reports.

PRINCIPAL INVESTIGATOR SHOULD:

Forward the original agreement to the contract specialist in the OCTR

Direct questions regarding the contract to the contract specialist

Sign the contract AFTER it has been negotiated (if PI finds terms agreeable)

PRINCIPAL INVESTIGATOR SHOULD NOT:

Attempt to negotiate the contract (whether written or verbal)

Sign the contract before it has been negotiated by the contract specialist

Send the contract to the Sponsor/CRO

REQUIREMENTS FOR CONTRACT SIGNATURE

In order for the contract to be signed, the following requirements must be met:

Contingent approval from the IRB Complete negotiation of the budget Complete negotiation of all ancillary agreements,

(such as a letter of indemnification)

CONTRACT SIGNATURE

The agreement must be signed by an authorized representative of the institution, such as the Associate Vice President of Research and Finance Administration.

Typically, the agreement must also be signed by the Principal Investigator.

COMMUNICATION The PI should communicate with the contract

specialist if there is a provision in the contract that is questionable or not agreeable.

The Contract Specialist will communicate with the PI or study coordinator if there are abhorrent provisions in the contract such as (a PI cannot have other competing studies, PI must enroll first subject within first month of trial opening, etc.).

TOP REASONS FOR DELAYS IN CONTRACT NEGOTIATION

Letter of Indemnification Resistance to State Mandates Turnover of Employees at CROs Lost Contract Lack of Communication Budget

CONTRACT PROCEDURE IN A NUTSHELL1. PI or Study Coordinator receives CDA or Contract.

2. Contract or CDA is forwarded to Contract Specialist.

3. Contract Specialist directly negotiates the agreement with the sponsor or CRO.

4. Contract Specialist will contact PI or Assistant Attorney General if there is a question or concern.

5. Contract Specialist will finalize negotiations of the contract and ensure all other contract components have been approved (i.e. budget, letter of indemnification).

6. Contract Specialist will obtain signatures from a UCHC representative and the PI.

7. PI will answer IRB contingencies (if any).

8. Clinical Trial will commence once contingencies have been met and the IRB has issued final approval.

THANK YOU FOR ATTENDING!