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UUSOP-13-A: Clinical Research Institutional Fee Schedule

Supplement A - Cost Structure Rationale

Version Date: September 27, 2023

  1. Introduction and Purpose
  2. Definitions and Acronyms
  3. Rationale
  4. References

 

The scope and purpose of this SOP is to set forth requirements for the conduct of industry sponsored clinical trials within the University of Utah. This SOP may be used to guide the conduct of other types of clinical research studies to promote standardization and proper clinical research billing compliance practices.

 

Introduction and Purpose 

The Clinical Research Institutional Fee Schedule (UUSOP-13) is set forth as a standardized cost structure to be utilized when participating in industry sponsored research. Fee standardization within the University of Utah promotes consistency and assists in adhering to proper research billing compliance. Information in this document outlines the rationale for the cost structure to allow proper oversight of research at the University of Utah.

 

Definitions and Acronyms 

Clinical Research: Clinical research includes all research involving human participants. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available.

Clinical Trial: Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.

CMS: Centers for Medicare & Medicaid Services
CRF: Case Report Form
CTO: Clinical Trials Office
CTSI: Clinical & Translational Science Institute
eCRF: Electronic Case Report Form
GCP: Good Clinical Practice
HIPAA:        Health Insurance Portability and Accountability Act
IB: Investigator’s Brochure
ICF: Informed Consent Form
IDDF: Investigational Drug Data Form
IDE: Investigational Device Exemption
IDS: Investigational Drug Services
IND: Investigational New Drug
IRB: Institutional Review Board
PI: Principal Investigator
SAE: Serious Adverse Event
SIV: Site Initiation Visit
SOP: Standard Operating Procedure
SUSAR: Suspected Unexpected Serious Adverse Reaction

 

 

  1. Administrative Start-up: Fee will be assessed based upon the specifics of the protocol and will include, but is not limited to the following (as applicable):
    1. Internal Study Review
      • Meeting with research staff: Principal Investigator, Sub-investigators, study coordinators, lab personnel, finance personnel, contract personnel and Investigational pharmacy
      • Familiarization with the study protocol and review IB
      • Determine logistics of study execution (working with ancillary services in additional to outpatient/inpatient locations)
      • Preparation for Sponsor visit (site initiation)
    2. Study Preparation
      • Training on sponsor specific Data Capture Systems (eCRF)
      • Training on sponsor protocol
      • Training on sponsor specific equipment, rating scales, GCP
      • Creation of source templates based on the study protocol
      • Creation of subject charts, logs, trackers
      • Provide training to support staff on study procedures as applicable: back-up study coordinator, lab, investigational pharmacy, clinic/floor nurses
      • Investigator Meeting (travel time & attendance)
    3. Imaging/Testing Preparation
      • Determine scope of service and requisite space
      • Staff training on the study protocol and lab manual
      • Inventory and store adequate supplies and ensure receipt of necessary items
      • Local Equipment accountability and calibration logs (i.e., BP monitors, ECG’s, etc.)
    4. Investigational Pharmacy Preparation
      • Determine supplies required for study drug administration
      • Logistics of study drug dispensing
      • Accountability documentation/CRF requirements
      • Collecting previous and current temperature logs
      • Planning for study drug retrieval/disposal
      • Associated fees will be passed on to sponsor via line-item costs
    5. Research Location Assessment and Procurement
      • Evaluation of trial needs in terms of space and personnel
      • Application for use of space and personnel as indicated
      • Completing physician order templates, laboratory order forms, etc.
  2. Clinical Trials Office Fee & Quarterly Department Maintenance. Clinical Trials Office Fee charged to all studies, irrespective of sponsor to allow adequate regulatory oversight and compliance with GCP, Human Subject Protection, and University requirements. Some of the CTO activities conducted at our site that are included in the fee for this and all trials:
    1. Internal Feasibility Assessment
      • Addressing pre-trial questionnaires
      • Providing required documents to sponsor (site information sheet, GCP, etc.)
      • Assessing eligible study population resources
      • Preparing for Sponsor visit (site selection)
      • Completing Sponsor visit (site selection)
    2. Providing streamlined and consistent contracting and budgeting processes to decrease startup and amendment timelines.
    3. Providing quality assurance and improvement to the proposed clinical research project.
            •  Protocol review to:
      1. Streamline any potential IRB conflicts
      2. Address protocol issues that would potentially be misinterpreted by the Principal Investigator (leading to study decline)
    4. Data queries to determine feasibility of recruitment efforts and the adequate population specific to the protocol.
    5. Determining the extent and duration of regulatory requirements relating to the population being studied, especially crucial due to working with special population participants.
    6. Providing recruitment planning and retention assistance
    7. Continuing quality assurance and improvement to the proposed clinical research project throughout life of trial
    8. Ensure protocol adherence by:
      1. Reviewing informed consent process in real time
      2. Identifying areas of local risk (i.e., protocol training, staffing, study procedures, etc.)
      3. Training on protocol amendments
      4. Revising documentation to maintain consistency with protocol amendments
    9. Managing audit prep of subject charts and regulatory documents when notified of submission of NDA, FDA, or sponsor audits
    10. Providing additional quality control on case-by-case basis to ensure data integrity and subject safety. Examples that necessitate internal quality control could include:
      1. Sponsor monitor turnover
      2. High enrollment (high risk for audit)
      3. Complexity of trial (phase I, study endpoints)
  3. IRB Preparation and Review
    1. Regulatory Preparation
    2. Regulatory document collection, copying and submission (mailing)
    3. Create and maintain the Investigator Site File
    4. Maintain correspondence with the Sponsor and all institutional departments regarding the status of the study
    5. Prepare ICFs per IRB specifications
    6. Prepare IRB submission
    7. Track submission progress and facilitate revision resolution, if applicable
    8. See https://irb.utah.edu/fees.php for local IRB Fee Schedule
  4. CMS Coverage Analysis. Fee associated with ensuring clinical trial billing compliance. Activities include but are not limited to:
    1. Performing comprehensive and independent review of all documents related to clinical trial research study funding, including the research study budget, protocol, contract, informed consent, and other supporting core documents.
    2. Completing coverage analysis by reviewing and documenting CMS guidelines and policies for national and local coverage determinations.
  5. Sponsor monitoring
    1. Scheduling and coordinating with research staff; Principal investigator, Sub-investigators, Study coordinators, Lab personnel, and Investigational pharmacy
    2. Preparing necessary documents for visit
      1. Uploading documents to shared platform
      2. Redacting and emailing/mailing documents
    3. Meeting between sponsor and research staff; Principal investigator, Sub-investigators, Study coordinators, Lab personnel, and Investigational pharmacy
    4. Over the shoulder electronic medical record review (study coordinator must be present – in person or remote)
    5. Monitor change (additional effort for research staff to acquaint new monitor with facilities and site procedures)
    6. See UUSOP-10 Monitoring Visits for Externally Sponsored Clinical Trials
  6. Pre-screening/Recruitment. Fee will be assessed based upon the specifics of the protocol and will include, but is not limited to the following (as applicable):
    1. Implementing recruitment strategies in accordance with IRB requirements and approvals
    2. Screening and determining subject eligibility based on inclusion/exclusion criteria and document each potential participant’s eligibility or exclusion by:
      1. Running internal queries
      2. Performing extensive medical chart review
      3. Communicating with treating physicians and additional clinical staff
      4. Screening clinic schedule for eligible participants daily
      5. Completing screening Log and ongoing submission to sponsor.
  7. Outside Agency Audit (not for cause) 
    1. Preparing for and hosting outside agency (sponsor, FDA, other external party) for site audit
    2. Providing required documentation
    3. See UUSOP-02 FDA Inspections
  8. Research Facility Fee
    1. Utilizing dedicated research space to complete protocol required visits
  9. Foreign Language Translation & Interpretation
    1. Onsite interpretation services
    2. Coordinating and scheduling with interpreter
    3. Translating study documents – i.e., Informed Consent Form, Assent, Parental Permission Forms, etc.
    4. See “Inclusion of People Who Speak Spanish in Research” Policy
  10. Document Archival and Storage
    1. Storing of study documents to comply with HIPAA regulations
    2. Compiling and organizing study documents at study closeout to prepare for archival
    3. Purchase of archival boxes
    4. Length of storage is per contract or protocol, whichever is longer
    5. In the event the contract or protocol does not clearly state the required length of storage, site will invoice sponsor 15 years’ worth of annual fees at closeout
    6. See UUSOP-06 Study Records Management
  11. Site Closeout. Fee encompasses all study close out activities, which include but are not limited to:
    1. Conducting study close out visit with sponsor
    2. Communicating with sponsor and additional research staff regarding close out activities
    3. Completing and reporting final queries
    4. Coordinating closeout with investigational pharmacy, laboratory, etc.
    5. Performing financial audit of all study related payments
    6. Preparing and submitting administrative forms necessary to close out account
  12. CTMS Fees. This covers the software license fee for access to the University of Utah’s Clinical Trial Management System (CTMS), OnCore, which supports the following activities over the lifetime of the study:
    1. Reconciliation of financial management, invoicing, and compliance monitoring
    2. Tracking and payment of clinical research study billing
    3. Participant tracking and payment (compensation/reimbursement)
    4. Creation and maintenance of e-binders for regulatory documents
    5. Reporting of clinical trial management and financial milestones
  13. IDS Pharmacy. Fees will be assessed based upon the specifics of the protocol and will include, but is not limited to the following (as applicable):
    1. Setup
      1. Reviewing protocol
      2. Preparing forms
      3. Meeting with PI and study team
      4. Developing dispensing guidelines and IDDF
      5. Inservicing pharmacy staff
    2. IDS Pharmacy Drug Destruction
      1. Ensuring destruction and/or return handling
      2. Fee is charged at study initiation
    3. IDS Pharmacy Protocol Amendment
      1. Tier 1
        1. All protocol amendments
      2. Tier 2 
        1. Redesigning Epic scheduling/ordering system & adding additional arms
        2. Completing additional inventory
        3. Updating study binders
    4. Maintenance
      1. Ordering & receiving investigational product
      2. Completing monthly inventory
      3. Documenting record maintenance
      4. Fee begins after Site Initiation Visit, or after Investigational Product is received (whichever occurs first)
    5. IDS Pharmacy Special Monitoring
      1. Creating manual logs
      2. Documenting monthly temperatures
      3. Additional monitoring of study drug
    6. IDS Pharmacy Additional Paperwork
      1. Manually completing and/or signing protocol required form/worksheet
    7. IDS Pharmacy Closeout
    8. Quote provided by IDS Pharmacy
  14. Laboratory Setup
    1. Determine scope of service and requisite space for specimen acquisition, processing, and storage
    2. Staff training on the study protocol and lab manual
    3. Inventory and store adequate supplies and ensure receipt of necessary items
    4. Collecting lab normal ranges
    5. Collecting Equipment temperature logs monthly (i.e., freezer/ refrigerator)
  15. Specimen processing management fee
    1. Receiving and storing sponsor provided laboratory kits and supplies
    2. Tracking and maintaining sponsor provided laboratory kits and supplies
    3. Disposing of expired sponsor provided laboratory kits and supplies
    4. Rates vary depending upon the following:
      1. Number of central labs
      2. Total kits
      3. Kits per time point
      4. Specimen schedules
      5. Timed collections
      6. Timed ECGs
      7. After hours and weekend collections
  16. Radiology Setup & Maintenance
    1. Quote provided Radiology and Imaging Sciences
  17. Radiological Drug Research Committee and Human Use Subcommittee
    1. Providing regulatory support to prepare the Protocol Radiation Use Sheet (PRUS). Review is mandatory for all studies requiring imaging that uses radiation, radiation therapy, and any kind of radioactive agent.
  18. Shared Investigator Platform Setup & Maintenance
    1. Registering and creating profiles in system
    2. Uploading applicable documents
    3. Maintaining and updating profiles as needed
  19. Ancillary Services Sponsor Required Protocol Training
    1. See UUSOP-03 Protocol Training for Investigators and Study Staff
  20. Sponsor specific equipment maintenance & storage
    1. Receiving and storing sponsor provided equipment
    2. Tracking and maintaining sponsor provided equipment
    3. Exchanging malfunctioning/damaged equipment
    4. Returning sponsor provided equipment
  21. Safety Event Reporting and Follow-up
    1. Notifying sponsor of SAE as outlined in protocol (typically 24 hours)
    2. Completing SAE report form as outlined in protocol
    3. Following resolution/permanent outcome as outlined in protocol
    4. Obtaining medical records from external facilities/hospitals
    5. Redacting and emailing/mailing source to sponsor
    6. Other reportable events may include:
      1. Adverse events of Special Interest
      2. Unanticipated Problems
      3. Unanticipated Device Effects
      4. Immune-mediated Events
  22. Pregnancy Follow-up
    1. Following pregnancy to term as outlined in protocol
  23. IND/SUSAR External Safety Reports
    1. Reviewing and acknowledging sponsor provided safety reports
      1. Event is unforeseen in terms of nature, severity, or frequency
      2. Event is related or likely related to participation in research
      3. Event likely affects the safety, rights and welfare of current participants or suggest that the research places subjects or others at a greater risk of harm
    2. Managing sponsor safety reporting portal
  24. Participant Payments
    1. Directly administering stipends and/or reimbursements to clinical trial participants
    2. Debit cards are valid for three years after activation. At the expense of the project, expired cards should be replaced as necessary.
  25. Budget Translation Fee
    1. Translating site budget to sponsor template
    2. Amending sponsor template to remedy errors and identify unmarked updates
  26. Institutional Oversight Fee
    1. Preparing study to present to various committees for review and prioritization
    2. Overseeing protocol trainings and study coordination
    3. Reviewing adverse events and protocol deviations
    4. Reconsenting and overseeing participant education
    5. Engaging in sponsor correspondence, signoffs, study teleconferences, etc.
    6. PI effort is removed from the per-patient costs since this covers all PI oversight.
    7. See UUSOP-04 Investigator Responsibilities
  27. Primary Children’s Hospital Board Review
    1. Fee associated with performing research at Primary Children’s Hospital location (Intermountain Healthcare)
  28. Center for Quantitative Cancer Imaging (CQCI)
    1. Setup
      1. Reviewing protocol and related documents including imaging manuals and CRFs to valuate participant eligibility requirements, image acquisition specifications, image analysis requirements, response assessment criteria, and determination of routine versus research imaging requirements.
    2. Analysis and response assessment
      1. Image analysis and response assessment incurred for each participant time-point resulting for disease assessments; additional fees assessed for multiple response criteria. Response criteria includes: RECIST, WHO, IWRC, Cheson, Choi, irRC, IMWG, RANO, EORTC, PERCIST, etc.
    3. See HCI Policy 005-19
  29. CTSI Application Submission and Startup
    1. Fee associated with review and approval of new protocol applications
    2. Quote provided by CTSI
  30. Cell Therapy and Regenerative Medicine Startup
    1. Fee associated with protocol review, budget development, completion of site visit, and protocol required training
    2. Quote provided by Cell Therapy and Regenerative Medicine
  31. CTSI Biomedical Informatics Core 21 CFR Part 11 Compliance Maintenance
    1. Fee is associated with use of CTSI REDCap instance where a project is instantiated for electronic data capture and/or electronic informed consent.
    2. Overseeing REDCap project implementation, procedures, and access.
      1. Reviewing project workflow
      2. Following validated procedures
      3. Implementing and reviewing roles and privileges assigned to project
      4. Verifying training module completion for all study team members
    3. Electronic Data Capture project implementation and build adherence by:
      1. Enabling enhanced features for document control, record locking and file repository storage features for 21 CFR Part 11 compliance
      2. Reviewing and approving implementation changes for the REDCap project for the lifecycle of the study
    4. Electronic Informed Consent Review
      1. Reviewing IRB approved consent documents to ensure implementation is following validated procedures.
      2. Ensuring REDCap electronic consent framework is accurately implemented following the validated procedures for the CTSI REDCap instance and approved project templates.
      3. Reviewing and approving implementation changes for the REDCap project for the lifecycle of the study.

 

References 

Last Updated: 3/22/24