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Elements of an Audit

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. Establishing a unique research billing number
  • Verification 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
    • Attainment of Billing Employer Account Number (BEAN)
    • Identification of research subject by obtaining an individual Case Number for each research subject
    • 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