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Introduction and Background

The University of Florida and College of Medicine are required to comply with all federal and state regulations associated with fiscal management of clinical trials. Risk management and auditing capabilities are needed to ensure clinical trials are conducted in a compliant, lawful and ethical way that benefits study participants, faculty, employees, the university and affiliated healthcare providers.

In December, 2005, the Clinical Trials Compliance Office (CTC) and Director position was established by the Dean of the College of Medicine; placed under the authority of the Senior Associate Dean, Research Administration and Compliance (COM), Associate Vice President for Research; and endorsed by the Senior Vice President, Health Affairs.  CTC was created to develop, coordinate, communicate, plan, implement, monitor, and report fiscal compliance policies, standards and processes for clinical trials research. CTC provides fiscal training, education and support to investigators and their designated staff to facilitate the successful conduct of clinical trials. 

The status of clinical trial fiscal compliance at UF and our clinical partners is often unclear and requires greater visibility, improved audit access, common business processes and effective information management systems to support risk management and protect our research enterprise.

There is an ever increasing effort from regulatory and law enforcement officials to focus on reducing fraud and abuse in research. For details regarding associated laws and regulations see (Gatorlink User Name & Password required): http://ctc.health.ufl.edu/starting/starting_out_Policy_Standards.shtml#Laws

Failure to comply with regulations associated with clinical research fiscal activities can include federal fines, withdraw of research funding, and other funding agency penalties limiting rights to engage in future clinical research or accepting further research funding.  Substantial penalties have been levied against institutions failing to meet Medicare requirements.  A 2006 study of 10 Academic Health Centers (AHCs) citied for improper, inappropriate or inaccurate clinical research billing and reporting reveals settlements ranging from $1 million to $35 million.  Recent settlements have involved both the research organization and the clinical service provider/hospital.

The Association of Academic Health Centers (AAHC), Forum on Regulations, Workgroup on Clinical Trials Billing/Budgeting includes representatives from 15 AHCs and Clinical Research Organizations.  The workgroup is addressing the challenges of fiscal compliance in clinical trials research. The purpose of the Forum on Regulations includes:

• To open a national dialogue on how regulatory processes impact the nation's academic health centers. 
• To examine ways to foster development of appropriate regulatory compliance frameworks for universities and the nation.

Engaging in active risk management is required to ensure clinical trial fiscal compliance. Availability of accurate, complete and timely information is needed to manage risk and ensure efficient audit capabilities. Effective information management processes and systems are needed to support risk management and auditing.

Fiscal compliance is a process that begins with the development of the study protocol, budget and contract and continues until the study closes and all clinical trial charges are settled. Clinical trial operations need to ensure that all payment sources are clearly identified and properly billed according to all federal and state regulations and sponsor contract specifications.

Clinical trial fiscal compliance information management needs include, for example, a comprehensive list of all clinical trials involving patients receiving care from covered organizations (Shands, UFP, etc.). Other requirements include support for investigators and their designees in providing the necessary information to hospital, professional and other outside service personnel that are required to support the execution of the study (Service Providers) to ensure proper billing procedures are followed for all concurrent payors. These concurrent payors may include the sponsor (contracting or granting agency), study participants and their 3rd party payors, including Medicare and other government payors.

Medicare is the largest insurance payer and has developed the most detailed policies and procedures regarding clinical trials. Many private payors have adapted Medicare policies for clinical trials. For this reason, we adhere to Medicare rules as our baseline practice for all clinical trials. Medicare is actively auditing Medicare Service Providers to ensure full compliance to clinical trial rules and regulations.

The Clinical Trials Compliance (CTC) Office has made tremendous progress in developing and implementing clinical trial compliance processes, tools and training. A comprehensive, uniform CTC information management (IM) solution is needed to augment this support for effective and efficient CT budgeting, billing and compliance auditing activities by all stakeholders.

The Director, CTC Office and Senior Associate Dean, Research Administration and Compliance (COM), Associate Vice President for Research, and the UF and Shands clinical research and billing community have requested information management systems and tools to support them in their work. In response to this request, we propose the ‘Clinical Trial Compliance Information Management (CTC IM) Project’ detailed below.

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Project Description

Project Goal:

The goal of the Clinical Trials Compliance Information Management (CTC IM) Project is to investigate, develop and implement a CTC Information Management Solution to support the fiscal compliance requirements associated with risk management of UF Clinical Trials Research. 

Project Scope

The scope of the project is large and complex. Information, processes and systems in at least 3 separate legal entities are currently utilized in performing clinical trial research fiscal activities at the University of Florida. Over 100 research teams separately engage in the work of evaluating protocols, developing budgets, securing clinical services pricing, entering into contracts, tracking clinical services and billing, and reconciling study accounts. These teams partner with an equally large number of distinct clinical service departments at Shands Hospital and University of Florida Physicians (UFP), as well as other affiliated or outside clinical service providers in performing these clinical trial fiscal activities. In addition, at least 6 research units have purchased and attempted to implement stand-alone Clinical Trial Management software in recent years. All organizations, information/data, processes and information systems will need to come together in one uniform information management solution in order to be effective in managing risk and supporting fiscal compliance functions.

Systems, processes and tools will be developed to address the following: 

• Clinical Research Protocols: All research protocols, regardless of funding type, involving human subjects and clinical services.  Includes research studies performed exclusively within local research departments and units.  Also need to address non-UF researchers (ex: Community Physicians) performing research using Shands, UF and UFP clinical services.
• CTC Data: All data/information, documents, and processes associated with clinical trial budgeting, billing, contracting and associated auditing.
• Organizations: Includes all key stakeholder organizations including UF colleges, centers and institutes engaged in clinical research as defined above.  Currently the College of Medicine is required to utilize CTC processes, and CTC services/processes are available to all UF clinical investigators.  The scope of colleges required to utilize a uniform CTC processes will expand to the entire university.
• Clinical Trials Planning & Fiscal Processes: All processes will be addressed by the project:
  • Protocol Evaluation and Scientific Feasibility
  • Service Provider Operational Readiness including:
    • Budget Development
    • Clinical Trials Agreement and/or Award
    • IRB Approval
  • Patient Management Phase including:
    • Patient Screening/Enrollment/ Registration
    • Scheduling Services
    • Service Provided/ Charge Generated
  • Study Close Out Phase including:
    • Payment Reconciliation
    • Study Close

Project Objectives:

• Help ensure university-wide fiscal integrity in the conduct of clinical trials including billing, time and effort reporting, audit functions and patient services tracking. 
• Establish an effective and efficient information management (IM) solution in support of clinical trials budgeting, billing and auditing with built-in tracking abilities to decrease overall risk. 
• Adopt accepted and uniform CTC IM policies and processes utilized by all stakeholder groups for clinical trials fiscal activities (budgeting and billing cycles). 
• Determine the need for improvements to associated clinical research and clinical services billing administrative processes. 
• Clarify the relationship of the CTC IM solution to other clinical research and clinical services billing administrative, operational and work processes and tools.
• Meet the IM needs of the following key stakeholder support organizations and their functions:
  • UF Clinical Trials Compliance Office (CTC), Research Administration & Compliance (RAC), and Division of Sponsored Research (DSR):
    • Fiscal compliance functions, processes and reporting
    • Monitoring and auditing CT financial status of expenses, charges and payments including actual services versus budgeted
• UF Departmental Clinical Research Teams:
  • Proposal evaluation, routing, submission and approval including CT agreement, protocol, informed consent 
  • Development of fiscally compliant CT Study Budgets
  • CT billing, account and fiscal management including reconciliation and closure of account
  • Tracking of study participants and clinical tests/procedures 
• Hospital, Professional and other Outside Clinical Service Providers:
  • Pricing of clinical services 
  • CT billing, account and fiscal management including reconciliation and closure of accounts
  • Tracking clinical tests/procedures 

Project Deliverables:

The primary purpose of the project is to investigate, design, recommend, select, approve, implement and evaluate a CTC Information Management (IM) Solution including:

• Unified Governance Structure for compliance that supports the alignment of clinical research components of key stakeholder organizations including UF, UFP, and Shands Healthcare; establishing ongoing decision making authority, policy management, and funding.
• Organizational Structures
• Architectural Structures 
• Policies
• Business and IT Processes
• Develop, purchase and provide ongoing support for information systems, tools, hardware, software, and feeds/interfaces to enable connecting of current functions and information including, but not limited to finance and accounting (PeopleSoft), billing (BAR, others), budget development (Research Units), pricing and scheduling (Hospital and Clinics). 
• Metrics and indicators for tracking, quality management and auditing of processes, study document information and billing data.
• Improved or new clinical research and clinical services billing, administrative, operational and work processes and tools necessary to successfully utilize the CTC IM solution. 
  • Including digital availability of accurate and timely operational/organizational information, electronic document sharing and forms transmittal. 
• Cost distribution metrics/ongoing funding support models for the CTC IM solution
• Commitment to and implementation of ongoing support and resources for the approved CTC IM solution.

Initial Requirements of the CTC IM Solution:

• Facilitation of the management of administrative, financial and regulatory requirements associated with the non-clinical aspects of conducting clinical research.
• Scalability and flexibility for future changes in federal or funding agency regulations, growth, operations and infrastructure changes impacting clinical trials.
• Provision of electronic and digital functionality reflecting the business requirements that:
  • Ensure accurate charging and billing, promote compliance, and reduce the number of internal charging and billing inaccuracies.
  • Ensure accurate time and effort reporting
  • Properly allocate charges to awarded projects
  • Report financial support from other sources
  • Support operational work processes of key stakeholders, including document sharing, forms, operational communications and transactions.
• Provide the capacity to track clinical trial activity to ensure:
  • Contracts include financial terms that are consistent with the protocol and informed consent.
  • Budgets prospectively distinguish sponsor and routine care expenses.
  • Informed consent fully explains any potential out-of-pocket liability.
  • Billing reflects competitively discounted prices.
  • Audit controls of individual studies indicate compliance.
  • Coordination of activities occurs between all key stakeholders.

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Project Phases/Activities

Phase 1:

• Project Planning and Initiation:
  • Finalize and approve project charter/scope, justification, interfaces with other stakeholder groups and projects, schedule and preliminary project budget
  • Determine, convene and train Project Organization
  • Develop a Communications Plan
  • Develop a Quality Assurance Plan
  • Develop a Risk Management Plan
  • Develop a Change Management Plan and Exceptions Process
  • Maintain and manage an “Issues Log”
  • Implement project document management processes and tools
• Evaluate Current State: Investigate and understand current CTC fiscal:
  • Business processes
  • Data flows and relationships
  • Supporting clinical research administrative and fiscal information management and technology systems
• Determine desired clinical trials fiscal management operating model.
• Determine desired clinical research enterprise ‘architectures’ including:
  • Organizational
  • Business
  • Data
  • Information Technology
• Determine and rank IT Business Requirements: Identify clearly defined requirements that reflect the needs of the clinical research community; establish a methodology for the design, assessment and evaluation process for CTC IM solutions.  Organize requirements first by subject area and then by specific requirement:
  • Organizational Requirements (ORG) – Requirements related to how research is organized, roles and responsibility of various departments, and overall functional requirements for the system
  • Proposal Development (PD) – Requirements directly related to the creation, routing and submission of proposals
  • Budget Development (BD) – Requirements related to budget development, versioning, and re-budgeting
  • Feeds/Interfaces (INTF) – Requirements related to instances where systems will have to communicate with another system such as Hospital or Practice billing and registration, PeopleSoft, IRB
  • Reporting (RPT) – Requirements related to using data that is captured entirely or partially within the solution
• Re-evaluate and modify as needed the Project Organization and required resources.

Phase 2:

• Evaluate & Select CTC IM Solution
  • Finalize methodology for the design, assessment and evaluation process for the CTC IM solution
  • Involve and confer with all appropriate UF compliance organizations to ensure the CTC IM solution is in compliance with necessary privacy, security, IRB, VA and other regulatory and legal requirements
  • Determine desired business processes/work flow in response to operating model
  • Determine desired data flow, relationships and resulting data architecture
  • Evaluate all requirements and design information architecture
  • Identify and evaluate CTC IM solution options
  • Recommend and select the final CTC IM solution
• Implementation
  • Develop an Implementation Plan
  • Acquire CTC IM solution components (hardware, software, etc.)
  • Integrate systems and build interfaces
  • Test the CTC IM solution
  • Train research, administrative and IT staff
  • Complete execution of the CTC IM Implementation Plan
  • Investigate and recommend cost distribution metrics/ongoing funding support model(s)
  • Investigate and recommend unified governance model

Phase 3:

• Evaluation & Finalize Ongoing Support
  • Evaluate the implemented CTC IM solution
  • Finalize the implementation of ongoing support mechanisms and resources
  • Finalize the implementation of cost distribution metrics/approved funding model for ongoing support
  • Finalize the implementation of Unified Governance Structure
  • Remediation as needed
• Project Closure

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Measures of Success

The following standards will be used to determine the project’s success:

• Audits of clinical research studies reveal all studies appropriately bill to patients, third party payors, federal health care programs and other Clinical Service Providers.  Bills were paid from the right payment sources to the right clinical service provider.  Audits show no variances in the following:
  • Correct services and costs are identified
  • Correct amount is invoiced for services
  • Correct amount is paid to invoices
• Investigators, study coordinators, research administrators and billing staff (key stakeholders) experience full availability and desired functionality when using the CTC IM solution, based on pre- and post-project surveys.
• The combined time and effort required by investigators and study coordinators to perform clinical trial fiscal activities, from the initial budget building stage to study closure is reduced, based on pre- and post-project surveys.
• All key stakeholders receive training in the use of, and reliable customer support for the CTC IM solution.
• All key stakeholders uniformly use the CTC IM solution.
• Unified governance structure is established and functioning.

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Key Stakeholder Organizations:

The key to clinical trials compliance is coordination.  However, adapting to the operational aspects of the clinical research environment means overcoming multiple barriers including the fact that the major participating organizations (UF, Shands, and UFP) are legally separate. 

The current environment across organizations involved in clinical trials fiscal and billing operations poses challenges to our ability to engage in sound fiscal clinical research practices.  Close collaboration and involvement is required by all key stakeholder organizations including, but not limited to:

• College of Medicine and other HSC and UF colleges, research centers and institutes engaged in clinical research in any and all locations
• Shands HealthCare
• University Florida Physicians (UFP)
• UF Division of Sponsored Research (DSR)
• College of Medicine, Research Administration and Compliance (RAC)
• Clinical Trial Compliance Office
• UF Bridges (PeopleSoft)

(See Project Organization ‘Oversight Team’ for additional representative organizations)

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Key Stakeholder Groups:

Coordination is required among all key stakeholder groups including, but not limited to:

• Principal Investigators and Research Teams
• Research Administration (CTC, RAC, DSR)
• Research Departments and Divisions within the COM and all HSC colleges
• Contracts and Grants
• All IRBs
• Hospital, Professional and other Outside Clinical Service Providers
• Sponsors
• Physicians and Nurses caring for study participants
• General Counsel (COM, UF and Shands Healthcare, and possibly others)
• Compliance (UF and Shands HealthCare) 
• Study Participants
• IT Service Providers

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Impact Analysis

Impact on Stakeholders

• Key stakeholders will have the support of effective, uniform, electronic information management systems, tools and processes for fiscal research activities.  Needed fiscal and administrative data will be stored and available in one location ensuring completeness, accuracy and ready access. This central repository for clinical research activity (i.e. paperwork and administrative control) and important information concerning the trials will be available at anytime to all stakeholders.
• Online access to operational information, forms, services and fees data, and web-based transmittal/communications capabilities will be available to all stakeholder groups.
• Key stakeholder groups will experience a reduction in the time and number of interactions required to obtain and manage clinical trial fiscal data and information. 
• The risk to Investigators and the university of non-compliance with associated regulations will be significantly reduced.

Impact on Operations

• Operational interactions between research teams, research administration, Shands and UFP fiscal and clinical staff will become more effective, efficient and timely.  Reductions in errors and miscommunications will result from utilization of common shared processes, systems and tools.
• The time required to evaluate study proposals from sponsors will be reduced.  Investigators, departments, colleges and UF will be better able to ensure all study costs are covered. 
• Policies and standardized fee schedules will reduce complexity and increase the accuracy of costing activities.
• Clinical Service Providers will be assured the costs of procedures are appropriately invoiced and paid in a timely manner.
• Research administrative personnel will be able to close and reconcile study accounts more quickly and efficiently.
• Auditing functions will require less time and produce more accurate and complete results.
• Process redesign and improvements together with adoption of a uniform CTC IM solution requires a commitment by all stakeholder groups to effective change management and a willingness to adopt new ways of doing work.  Involvement of all stakeholders in all phases of the project is essential to a successful outcome.

Impact on existing systems

• Many research groups utilize manual and paper processes to manage clinical research and fiscal data. An electronic information management system will help to improve efficiency and streamline processes.
• Several organizations maintain information systems that support clinical trial research activities including:
  • UF Bridges (grant accounting)
  • UFP and Shands Healthcare (billing and patient scheduling/tracking)
  • Research Administration (DSR, RAC)
  • IRBs
  • Research Departments/Programs (a variety of Clinical Trial Management Software - CTMS).  However, most departments using a CTMS do not utilize the ‘billing’ or ‘fiscal’ modules, if they exist. 
• The CTC IM solution is likely to separate into "oversight" and "execution".  Oversight systems will coordinate compliance data into comprehensive views for risk management, while execution systems will gather and integrate research subject data and perform billing functions.  Appropriate interfaces will be needed for cross-system information flow. 

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Relationship to Other Projects

Existing Clinical Trial Management Software

The Center for Clinical Trials Research, Department of Cardiology and other Clinical Research Departments/Programs have implemented a variety of Clinical Trial Management software in recent years.  Consideration will need to be given to these existing information systems when determining requirements and selecting/building the CTC IM solution.

CTSI-CTRIP

UF is pursuing an NIH Institutional Clinical and Translational Science Award (CTSA). UF CTSI Regulatory Support for research teams will promote the protection of human subjects and facilitate regulatory compliance, and assist investigators in their documentation requirements.

A component of the UF CTSI is the Clinical and Translational Research Informatics Program (CTRIP).  The program includes a Clinical Trials Management Work Group that is examining options for a commercial clinical trials management software package. Their aim is to implement a user-focused approach to providing investigators with state-of-the-art systems and services to facilitate participant recruitment and scheduling, task management, electronic data collection (EDC) and budgeting functions through the use of commercially available clinical data management systems (CDMS) and locally developed systems.  The group is evaluating different systems for broader implementation, in collaboration with the Clinical Trials Compliance Office.  Options include free-standing systems such as Study Manager and clinical trials management modules associated with the ambulatory care electronic medical record (a-EMR) (see below). 

The CTC IM Project organization includes representatives from the CTSI program.  Collaborative and parallel efforts will be undertaken to determine ‘requirements’ for both research administration/fiscal compliance and for clinical research data management needs of investigators.  The two efforts will converge for the ‘evaluation and selection’ stage of the CTC IM Project to ensure the implemented IM solution meets all clinical research information management needs of investigators, avoids redundancy and reflects sound use of funding/resources.

a-Electronic Medical Record System

The UF College of Medicine University of Florida Physicians (UFP) is implementing an ambulatory care electronic medical record (a-EMR) in Gainesville. The system may include CTC compliance support modules and will also need to be included in the ‘evaluation and selection’ stage of the project. Participants in the a-EMR initiative are included in the CTC IM Project organization.  

(Back to CTC IM Project Homepage)

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