Contract Negotiation Synopsis

Introduction

The negotiation and execution of contracts is a substantial component of the genesis of a clinical trial. Clinical trials at UConn Health cannot commence until a contract has been fully negotiated, approved, and executed and the clinical trial has received final IRB approval.

Historically, the negotiation of clinical trial agreements contributed to the delay in the opening of pharmaceutical/industry clinical trials. OCTR has alleviated many of these issues by redefining the contract procedure to include the following:

1. Parallel budget determination
2. Standardization of contract templates
3. Organization of contract negotiation procedures
4. Coordination with the Institutional Review Board (IRB)
5. Full execution of contracts after IRB contingent approval

Types of Contracts

The OCTR negotiates industry-sponsored or investigator initiated industry-supported contracts, university-to-university agreements, co-operative group contracts and foundation-supported contracts, which include the following:

• Clinical Trial Agreements (CTA)
• Confidentiality Disclosure Agreements (CDA)
• Contract Amendments
• Letters of Indemnification (LOI)

OCTR does not negotiate:

• Federally funded investigator initiated agreements* **
• Clinical trials or clinical research in which the Prime Award is in response to a public solicitation (e.g., Request for Information (RFI), Request for Application (RFA), Funding Opportunity Announcement (FOA))

* In this instance, the proposals will be negotiated by the staff in the Sponsored Programs Services (SPS). If you are pursuing a federally-funded agreement or a study in which the prime award is in response to a public solicitation, please contact SPS at 860-679-4040 or go to their website.

** Appendix I: The following represent the main types of federally funded grant awards and projects that will continue to be negotiated by the Sponsored Programs Services (SPS) at UConn Health. See listing of all NIH grant mechanisms.

Research Grants:

• R01 – NIH Research Project Grant Program
• R03 – NIH Small Grant Program
• R13/U13 – NIH Support for Conferences and Scientific Meetings
• R15 – AREA: NIH Academic Research Enhancement Award
• R21 – NIH Exploratory/Development Grant Award
• R34 – NIH Clinical Trial Planning Grant
• R41/R42 – STTR: Small Business Technology Transfer
• R43/R44 – SBIR: Small Business Innovative Research
• R56 – NIH High Priority, Short-Term Project Award
• U01 – Research Project Cooperative Agreement
• K99/R00 – NIH Pathway to Independence (PI) Award

Career Development Awards (K series)

Research Training and Fellowships (T & F series)

Program Project/Center Grants

• P01 – Research Program Project Grant
• P02 – Exploratory Grant
• P30 – Center Core Grants
• P50 – Specialized Center Grants

Resource Grants

• R24 – Resource-Related Research Projects
• R25 – Education Projects
• X01 – Resource Access Program

Trans-NIH Program

• BISTI: Biomedical Information Science and Technology Initiative
• Blueprint: NIH Blueprint for Neuroscience Research
• Diversity Supplements
• Administrative Supplements
• ES I: New and Early Stage Investigators Policies
• GWAS: Genome-Wide Association Studies
• NIH Common Fund: NIH Roadmap for Medical Research
• OppNet: NIH Basic Behavioral and Social Science Research Opportunity Network
• PECASE: Presidential Early Career Award for Scientists and Engineers
• Stem Cells

Contract Negotiation Process

Industry Sponsored Clinical Trial Agreements

If an industry sponsor is interested in conducting a clinical trial at UConn Health, the sponsor will initially send a non-disclosure agreement or a confidentiality disclosure agreement (CDA) to the researcher. Once received, the researcher should forward the CDA to the contract specialist in the OCTR. The CDA will then be reviewed, negotiated, approved, and executed. Thereafter, the researcher will review the data and the study components in order to determine whether to participate in the study.

After review of the sponsor’s data and proposed study, the researcher and the sponsor will make a mutual decision whether or not to engage in the study. If the researcher decides to engage in the study, the sponsor will send a clinical trial agreement (CTA) to the researcher or the researcher’s study coordinator. The clinical trial agreement is then forwarded to the contract specialist in the OCTR for review and negotiation. Once the CTA is negotiated, the contract specialist will obtain signatures from an authorized representative of UConn Health, the researcher, and the sponsor.

Another type of CTA is the “University to University” agreement. University to University agreements are subcontracts with a university that has a governing contract with a company sponsor. The negotiation procedure for University to University agreements is similar to the negotiation procedure for industry-sponsored clinical trial agreements.

Investigator-Initiated Clinical Trial Agreements

An investigator-initiated clinical trial is one that is authored by the investigator and financially supported by industry, a foundation, or another university. The funding agency may send its own company contract to OCTR for negotiation, or OCTR may send the funding agency a clinical trial agreement generated by UConn Health. Thereafter, the negotiation procedure is generally tantamount to the process described above for industry-sponsored studies.

Cooperative Group Studies

UConn Health has master agreements with cooperative groups which are designed to promote and support clinical trials. OCTR negotiates all agreements pertaining to the cooperative group studies or its corresponding master contract.

Budget and Institutional Review Board (IRB)

All clinical trials that incur JDH and/or UMG and/or Dental charges will need a completed Budget Workbook before IRB submission. During contract negotiations, OCTR staff reviews the protocol, informed consent, and contract to ascertain that patient costs and patient injury language are in agreement within all documents. At the time of review, the IRB will also assess concordance among the protocol, patient consent, and contract relative to patient costs and patient injury language. If the protocol is contingently approved by the IRB, the contract can be signed by the Director of Sponsored Program Services and sent back to the company while contingencies are being met.

A clinical trial agreement cannot be signed until the study has received contingent approval from the IRB. Thus, an executed contract is not required for IRB submission. However, if a clinical trial agreement contains subject injury language, said language may be required for submission. The subject injury language can be requested from the OCTR.

No clinical trials can open or begin accrual without final IRB approval.

1. Preliminary Report of Audit Findings
   Based on the Research Financial Compliance Audit, a preliminary report is sent to the principal investigator and s/he is given 30 days to review for accuracy
2. Violations
   Major billing financial violations, or substantive systematic deficiencies are reported immediately to the Associate Dean of Clinical Research Planning and Administration

Final Report of Audit Findings

1. A final audit summary is provided to the principal investigator, with copies to:
   • Associate Dean of Clinical Research Planning and Administration
   • Vice President for Research Finance
   • Vice President of Research Compliance
   • Director of Sponsored Program Services
   • Compliance Integrity/Privacy Officer
   • It includes:
     1. Comments on audit procedure and the findings
     2. Description of deficiencies or violations
     3. Recommendations for corrective action plan, including correcting billing errors
2. The researcher is given 21 days to respond with a corrective action plan
3. When the corrective action plan is accepted and implemented and no outstanding items remain
   • A letter of acknowledgement is sent to the PI and the audit is officially closed
   • The financial compliance summary form is completed and attached to the file

Notification

• Written notification of pending audit is sent from the OCTR Administrative Fiscal Assistant. It is the responsibility of the research compliance monitor to schedule the visit after notice has been received.

Timing

• Random audits will be scheduled two to four weeks in advance; however unscheduled “mini” audits may be performed within five days.
• For cause audits may be performed without prior notice.

Random Audit for Financial Compliance

Scheduled Audit

This type of review is considered a full audit. Focus of review includes:

• Budget determination
• Delineation of PIC and RC
• Adherence to the Medicare National Coverage Decision (NCD)
• Adherence to the UConn Health research financial policies and state laws and regulations
• Appropriate approval from Medicaid and other third party payers for payment of RC associated with a clinical trial.
• Review may also include:
  1. review of contract
  2. review of PIC paid by sponsor
  3. review of RC paid by third party payer or participant
  4. review of all patient charges/billing
  5. review of any charges/billing for adverse events
  6. review of charges billed to the study Banner account #
  7. changes in budget
  8. changes in contract

Unscheduled Audit

This type of audit is done to assess one or two elements of the full audit, such as

• Budget delineation, or
• Patient charges.

For Cause Audit for Financial Compliance

This type of audit is performed when concerns regarding research financial compliance are brought to the attention of the Office of Clinical and Translational Research (OCTR), the Human Subjects Protection Office (HSPO), Institutional Review Board (IRB) or Research Compliance.

First Subject Reconciliation

A first subject reconciliation is completed early in the trial to establish that study related transactions are happening according to plan or that problems are found early and corrective action may be taken. Areas of focus are listed below.

• Research related charges for UMG and JDH are correct, complete and reflect the proper CPT/Procedure code in accordance with the Budget Workbook.
• All start-up fees were received from the sponsor and allocated to the study Banner fund. Regular study payments are correctly recorded (if yet received).
• Study personnel have allocated proper Time & Effort via payroll distribution or through cost sharing.
• Study related charges are paid to UMG or JDH at the proper rate and discount.

Investigators and study personnel are responsible for being knowledgeable of the following policies and procedures of the Human Subjects Protection Program (HSPP).

• 2009-001.0 – Reporting Unanticipated Problems to the Institutional Review Board (6/29/2018)
• 2009-002.0 – Reporting Non-Compliance to the Institutional Review Board (6/9/2023)
• 2009-003.0 – Imposing and Lifting Suspensions of IRB Approval or Imposing Terminations of IRB approval – (6/5/2023)
• 2009-004.0 – Required Reporting to Institutional Officials and External Agencies (12/30/2021)
• 2009-005.0 – Monitoring of IRB Approved Studies (6/5/2023)
• 2011-006.0 – Additional Protections – General (2/5/2018)
• 2011-006.1 – Additional Protections – Pregnant Women, Fetuses or Neonates (6/9/2023)
• 2011-006.2 – Additional Protections – Prisoners (3/16/2023)
• 2011-006.3 – Additional Protections – Children (6/15/2017)
• 2011-006.4 – Additional Protections – Other Vulnerable Groups (6/5/2023)
• 2011-006.5 – Additional Protections – Fetal Tissue Transplants (6/5/2023)
• 2011-007.0 – Definitions Applied to Policies (11/20/2023)
• 2011-008.0– Informed Consent – Forms (3/16/2023)
• 2011-008.1 – Informed Consent – Process (6/9/2023)
• 2011-008.2 – Informed Consent – Waivers and Alterations (1/22/2024)
• 2011-008.3 – Informed Consent – Assent (5/1/2017)
• 2011-008.4 – Informed Consent – Short Form (11/20/2023)
• 2011-008.5 – Informed Consent – Providing and Obtaining Informed Consent (6/5/2023)
• 2011-009.0– Institutional Review Board – Membership (6/5/2023)
• 2011-009.1 – Institutional Review Board – Submission of Materials (5/1/2017)
• 2011-009.2 – Institutional Review Board – Exemptions (6/9/2023)
• 2011-009.3 – Institutional Review Board – Expedited Reviews (4/25/2025)
• 2011-009.4 – Institutional Review Board – Convened Meeting Operations (11/20/2023)
• 2011-009.5 – Institutional Review Board – Review by Convened Board (11/20/2023)
• 2011-009.6 – Institutional Review Board – Consultants (5/1/2017)
• 2011-009.7 – Institutional Review Board – Assignment of Status Codes (6/9/2023)
• 2011-009.8 – Institutional Review Board – Appeals Process (6/9/2023)
• 2011-009.9 – Institutional Review Board – Verification of No Material Changes  (5/1/2017)
• 2011-009.10 – Institutional Review Board – More Frequent Review (7/20/2023)
• 2011-009.11 – Institutional Review Board – Studies Conducted in Foreign Locations (11/20/2023)
• 2011-009.12 – Institutional Review Board – Criteria for Approval (6/9/2023)
• 2011-009.13 – Institutional Review Board – Lapse in IRB Approval (6/9/2023)
• 2011-009.14 – Institutional Review Board – Human Subject Research Determinations (6/5/2023)
• 2011-009.15.a – Institutional Review Board – Reliance on UConn Health as IRB of Record (11/20/2023)
• 2011-009.15.b – Institutional Review Board – Reliance on External IRB (11/20/2023)
• 2011-009.16 – Institutional Review Board – Undue Influence  (8/17/2017)
• 2011-010.0 – VACANT
• 2011-011.0 – Research Personnel (6/9/2023)
• 2011-012.0 – Conflict of Interest – Research Personnel (6/5/2023)
• 2011-012.1 – Conflict of Interest – IRB Members (6/5/2023)
• 2011-013.0 – Translation Policy (8/17/2017)
• 2011-014.0– Health Insurance Portability and Accountability Act (HIPAA) in Research (10/29/2019)
• 2011-015.0 – Recruitment and Payment (6/9/2023)
• 2011-016.0 – Scientific Review (6/9/2023)
• 2011-017.0 – UConn Health as Statistical, Operational or Coordinating Center (8/17/2017)
• 2011-018.0 – Complaints, Concerns, Suggestions (8/17/2017)
• 2011-019.0 – Research Registries and Repositories (3/25/2022)
• 2011-020.0 – Humanitarian Use Device (6/5/2023)
• 2011-021.0 – Investigational Device Studies (9/26/2017)
• 2011-021.1 – Investigational Device – Single Emergency Use (9/26/2017)
• 2011-022.0 – Study Drug – General (6/5/2023)
• 2011-022.1 – Investigational Drug Studies (9/26/2017)
• 2011-022.2 – Investigational Drug/Biologic – Expanded Access for Treatment Use, Including Single Emergency Use (6/5/2023)
• 2011-023.0 – Educational Requirements (6/5/2023)
• 2011-024.0 – File Requirements & Record Retention Requirements (9/26/2017)
• 2015-024.1 – Record Retention Format (12/29/2015)
  
• 2011-025.0 – HSPP Evaluation / Institutional Support (11/20/2023)
• 2011-026.0– Planned Emergency Research (6/15/2017)
• 2013-027.0 – Additional Requirements – Department of Defense (11/20/2023)
• 2014-028.0 – Additional Requirements – National Institute of Justice (11/20/2023)
• 2014-031.0– Additional Requirements – Department of Energy (11/20/2023)
• 2014-032.0 – Additional Requirements – Environmental Protection Agency (11/20/2023)
• 2014-033.0– Additional Requirements – Federal Bureau of Prisons (11/20/2023)
• 2014-034.0 – Additional Requirements – Department of Education (Federal) (6/9/2023)
• 2023-035.0 –  HSPP Emergency Preparedness Plan (6/12/2023)
• Combined Policy Manual (pdf) (4/25/2025)

Roles and Responsibilities

The following items will be reviewed to understand the roles and responsibilities of the research team as they relate to financial compliance and clinical research:

• Budget workbook
• Delineation of PIC and RC
• Adherence to UConn Health policies
  1. Opening a clinical trial
  2. Identifying research patients
  3. Verirification of Continuous Monitoring Process (CMP) by study staff

Compliance/Case Review

1. Assessment of compliance with (UConn Health) policies:
   • Research patient billing policies and procedures
   • Identification of inpatient and outpatient services
   • Designation of PIC and RC
   • Opening a clinical trial
   • Correct billing procedure for charges
   • Identification of errors and corrective plan of action
   • Review may also include
     1. Documentation of research intervention
     2. Subject accrual
     3. Review of research records
     4. Review of clinic/medical records
2. Assessment of compliance with State of Connecticut regulations and laws relevant to billing of patients on clinical trials.
3. Assessment of compliance with federal regulations and laws relevant to billing of patients on clinical trials.

Informed Consent

1. Confirm consistency between contract, protocol and approved informed consent as it relates to financial compliance.
2. Confirm consistency between informed consent and actual patient charges as it relates to financial compliance.
3. Review may also include:
   1. Dates of approval and start of research
   2. Changes in protocol

The field of human subjects research is governed by several sets of regulations. Links to relevant sections of the code of federal regulations (CFR) and a brief description of the purpose of the regulation are provided below. The IRB forms and checklists are designed to address the requirements of these regulations and aid investigators and study personnel in ensuring compliance.

45 CFR  46 – Protection of Human Subjects (Office for Human Research Protections)
Subpart A of this regulation is often referred to as The Common Rule because several agencies abide by it. Subpart A is titled Basic HHS Policy for Protection of Human Research Subjects. Some of the key elements addressed within 45 CFR 46 include the following:

• IRB membership
• IRB functions and operations
• IRB review of research
• Expedited review procedures
• Criteria for IRB approval
• General requirements for informed consent
• Documentation of informed consent

Subparts B, C and D address the additional protections required for vulnerable populations. Subpart B addresses additional protections for pregnant women, human fetuses and neonates. Subpart C addresses additional protections for prisoners. Subpart D addresses additional protections for children.  The requirements of this regulation apply to all non-exempt federally funded human subject research.  At UConn Health this regulation is also the guiding premise for approval of non-exempt, non-federally funded research that is not subject to FDA regulations.

21 CFR 50 – Protection of Human Subjects (Food and Drug Administration (FDA))
This regulation applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, Drug and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for humans use, biological products for human use and electronic products. This regulation consists of Subparts A, B and D. Subpart A addresses general provisions of the regulation, e.g. scope and definitions. Subpart B addresses informed consent of human subjects. Subpart D address the additional protections for children. Some of the key elements addressed within Subpart B include the following:

• General requirements of informed consent
• Exceptions from the general requirements
• Exceptions from informed consent requirements for emergency research
• Elements of informed consent
• Documentation of informed consent

21 CFR 56 – Institutional Review Boards (FDA)
This regulation addresses several of the same key elements as 45 CFR 46, including:

• IRB membership
• IRB functions and operations
• IRB review of research
• Expedited review procedures
• Criteria for IRB approval

21 CFR 54 – Financial Disclosure by Clinical Investigators (FDA)
The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for making the appropriate certification or disclosure statement where the applicant either contracted with one or more clinical investigators to conduct the studies or submitted studies conducted by others not under contract to the applicant. Some of the key elements addressed include:

• Certification and disclosure requirements
• Agency evaluation of financial interests
• Recordkeeping and record retention

21 CFR 210 and -211 – Good Manufacturing Practices (FDA)
These regulations set forth the minimum standard for manufacturing, processing, packing or holding of drugs.

21 CFR 312 – Investigational New Drug Application (FDA)
This regulation applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act. Key elements addressed within the regulation include:

• Subpart A – General Provision (e.g. Scope, Applicability, Definitions, Labeling etc.)
• Subpart B – Investigational New Drug Applications
• Subpart C – Administrative Actions
• Subpart D – Responsibilities of Sponsors and Investigators
• Subpart E – Drugs Intended to Treat Life-threatening or Severely Debilitating Illnesses
• Subpart I – Expanded Access to Investigational Drugs

21 CFR 314 – Application for FDA Approval to Market a New Drug (FDA)
This part of the regulations sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them

21 CFR 812– Investigational Device Exemptions (FDA)
This regulation applies to clinical investigations of devices to determine safety and effectiveness. Key elements addressed within the regulation include:

• Subpart A – General Provision (e.g. Scope, Applicability, Definitions, Labeling etc.)
• Subpart B – Application and Administrative Action
• Subpart C – Responsibilities of Sponsors
• Subpart D – IRB Review and Approval
• Subpart E – Responsibilities of Investigators
• Subpart G – Records and Reports

21 CFR 803 – Medical Device Reporting (FDA)
This part establishes requirements for medical device reporting. Under this part, device user facilities, importers, and manufacturers, as defined in § 803.3, must report deaths and serious injuries to which a device has or may have caused or contributed, must establish and maintain adverse event files, and must submit to FDA specified followup and summary reports.

21 CFR 814 – PreMarket Approval of Medical Devices (FDA)
This part provides procedures for the premarket approval of medical devices intended for human use.

21 CFR 600 – Biological Products General (FDA)

21 CFR 601 – Licensing (FDA)

45 CFR 160 and 164 – Health Insurance Portability and Accountability Act (Office of Civil Rights)
The Privacy Rule establishes a foundation of Federal protections for the privacy of protected health information.

Protection of Pupil Rights Amendment, (U.S. Dept., of Education)
The Protection of Pupil Rights Amendment ((PPRA) (20 U.S.C. § 1232h; 34 CFR Part 98) applies to programs that receive funding from the U.S. Department of Education (ED). PPRA is intended to protect the rights of parents and students by ensuring that 1) schools and contractors make instructional materials available for inspection by parents if those materials will be used in connection with an ED-funded survey, analysis, or evaluation in which their children participate and 2) schools and contractors obtain written parental consent before minor students are required to participate in any ED-funded survey, analysis, or evaluation that reveals sensitive and/or private information.

Telephone & Fax:

Phone: 860.679.4040
Fax: 860.679.4014

Name	Role	Phone	Email
Victor Hesselbrock, Ph.D.	Senior Associate Dean for Research	860.679.8961	hesselbrock@uchc.edu
Ella Sun	Director	860.679.8961	elsun@uchc.edu
Rebecca Plocher	Admin Fiscal Assistant	860.679.1579	plocher@uchc.edu
Amanda Poirier	Budget & Financial Specialist	860.679.7816	ampoirier@uchc.edu
Barbara Jones	Reimbursement Analyst	860.679.4369	bjones@uchc.edu
Patricia Olsen	Admin Program Coordinator/Coding Reimbursement Specialist	860.679.3155	olsen@uchc.edu
Donald Deyo	Contracts Specialist		deyo@uchc.edu
General Email			octrclinicaltrial@uchc.edu

 

Per institutional policy 2006-07, staff in OCTR complete a Budget Workbook for any clinical trial performed at UConn Health which accrues John Dempsey Hospital (JDH) and/or UConn Medical Group (UMG) charges. A Budget Workbook must be completed prior to a study being submitted to the Institutional Review Board (IRB) for initial review, though a study may be submitted if the Budget Workbook is complete and budget negotiations are ongoing with the sponsor.

School of Medicine

• Medicare Review
• Budget Workbook
• Budget Negotiation

School of Dental Medicine

• Dental Budget Introduction
• Dental Budget Workbook
• Dental Budget Negotiation

Questions and Answers

Read questions and answers >

Human Subjects Protection Program (HSPP)
UConn Health
263 Farmington Avenue
Farmington, CT 06030-1511

Fax: 860-679-1005

Send questions, comments, concerns, or suggestions to:  irb@uchc.edu

Institutional Review Board (IRB)
L Building, 5th floor
UConn Health
263 Farmington Avenue
Farmington, CT 06030-1511

Questions regarding new study submissions & active approved research:

• Stephen MacKinnon – 860-679-8729
• Galina Prpich – 860-679-4849

Questions regarding IRB Reliance:

• Kate Hayden Ames – 860-679-8802

Request IRB Submission Education / Training or General iRIS Support:

• irb@uchc.edu

Questions regarding policy, regulations, post-approval monitoring Function:

• Rebecca Burke – 860-679-3054

Administrative Manager

• Julia Blair – 860-679-7555

Office Fax: 860-679-1005