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Preparing For A VA Compliance Audit. Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas Veterans Health Care System, San Antonio, TX. An Active Monitoring and Auditing Program is Important for…. Maintaining participant and staff safety

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preparing for a va compliance audit

Preparing For A VA Compliance Audit

Kimberly Summers, PharmD

Assistant Chief for Clinical Research

South Texas Veterans Health Care System,

San Antonio, TX

an active monitoring and auditing program is important for
An Active Monitoring and Auditing Program is Important for…
  • Maintaining participant and staff safety
  • Protecting the reputation of the PI, staff, sponsor, and institution
  • Maintaining data quality
  • Protecting funding
  • Measuring compliance with regulatory requirements
components of a monitoring program
Components of a Monitoring Program
  • Investigators and their staff
  • Research Compliance Office
    • STVHCS
  • IRB
  • Research Pharmacy
  • External Monitors
  • R&D Committee
layers of the local monitoring program
Layers of the Local Monitoring Program

R&D Committee

Specialized Monitoring

Compliance Office



Research Subject

Data Security

Privacy Office

Research staff

Sponsor Monitors

Research Pharmacy

QA/QI Subcommittee

components of a local monitoring program
Components of a Local Monitoring Program

The PI has primary responsibility for the proper conduct of the study; this includes appropriate monitoring by the research team

Provides first and most important level of local research monitoring

Closest to the action; can respond to issues earlier and more quickly

Can identify and correct problems before they harm participants or reach institutional visibility

Investigator Responsibilities

role of external monitors in local monitoring
Role of External Monitors in local Monitoring
  • VHA Directive From Chief Research and Development Officer:
    • Each research office must develop procedures that will ensure all serious findings and concerns are appropriately addressed and the appropriate facility officials and committees are notified
  • Types of External monitoring visitors
    • Pharmaceutical companies
    • Study sponsors
    • Contract Research Organizations (CROs)
    • VA Cooperative Studies Program
    • UTHSCSA Compliance Office
auditing vs monitoring
Auditing vs Monitoring
  • Audits are in addition to the more detailed monitoring of studies by the research team and sponsor
  • Audits are an independent evaluation by someone who is not directly associated with the research
research is concerned with discovering the right thing to do audit with ensuring it is done right

‘Research is concerned with discovering the right thing to do; audit with ensuring it is done right’

Smith, 1992; editor of the BMJ

vha directive 2008 064
VHA Directive 2008-064

Research Compliance Officers And The Auditing of VHA Human Subjects Research To Determine Compliance With Applicable Laws, Regulations, and Policies

“An active auditing program should provide reasonable assurance of the integrity of the research program and that adequate protections for research subjects are in place.”

The Director must “ensure that the local HRPP conducts periodic audits of VA-approved research to assess compliance with all applicable laws, statutes, regulations. . .”

research compliance office
Functions independently and objectively in the monitoring of research activities

Reviews research activities from both a regulatory and human subject protection perspective

Reports to the Medical Center Director

Findings reported to IRB and R&D Committee for appropriate action

Research Compliance Office
how does the compliance office monitor research
How Does the Compliance Office Monitor Research
  • Investigator Site Audits
    • Routine
    • For Cause
  • Monitoring the Informed Consent Process
  • Quality Assurance Audits
    • IRB files and processes
    • R&D files and processes
    • Research Pharmacy files and processes

For-Cause or Targeted Audits

  • Problem identified by a bad outcome
  • Potential problem identified by a component of the HRPP
    • Clinical, pharmacy, or other institutional staff
    • IRB
    • R&D Office
    • Sponsor
    • Research subject
  • Increased potential for research non-compliance
    • Evidence of a poorly educated investigator
    • “Flying under the radar” investigator
routine investigator audits
Routine Investigator Audits
  • Check documents and procedures at the project level
  • Each VA-approved human research protocol is completely audited at a minimum of once every 3 years
  • Compliance with regulations for informed consent is audited at a minimum once a year
the audit process is designed to be support rather than punitive

The audit process is designed to be support rather than punitive

The process is meant to be useful in helping investigators and staff to achieve best practice in their research

why has my study been chosen
Why Has My Study Been Chosen?
  • Studies for routine auditing are chosen at random
  • The STVHCS and UTHSCSA Compliance offices coordinate auditing visits to avoid duplication
what will happen at the auditing visit
What Will Happen at the Auditing Visit?
  • The auditor will use an auditing tool consisting of a checklist for determining compliance with GCP and local policies and procedures
  • STVHCS and UTHSCSA use the same auditing tool
  • The auditors will visit the study staff work area to review study documents
    • A study staff member must be on hand to facilitate the review
elements of the auditing tool
Elements of the Auditing Tool
  • Regulatory documents
  • IRB submissions
  • Informed consent
  • Subject and/or data use
  • Banking of specimens
  • Inclusion / exclusion elements
  • Serious adverse events
  • Investigational drug
  • Study site
  • Confidentiality / data security
additional elements of the auditing tool
Additional Elements of the Auditing Tool
  • Participant review
    • Consent form
    • Inclusion / exclusion criteria
    • CRF / source documents
    • UPIRSO reporting
    • Exceptions / deviations
    • VA documentation
  • Investigational devices
  • Principal investigator initiated / sponsored trials
participant and regulatory file reviews your record keeping
Participant and Regulatory File Reviews – Your Record Keeping
  • Purpose of record keeping
    • To keep an orderly account of progress
    • To facilitate the detection of errors
    • To meet legal requirements
    • To supply information required for taking certain actions
      • Deviations, exemptions, etc.
      • Notes to file
participant review portion of audit
Participant Review Portion of Audit
  • Research records and source documentation
  • Adherence to IRB-approved research protocol
    • Inclusion/exclusion criteria
    • Screening procedures
    • Study procedures
    • Follow-up procedures
  • Documentation of informed consent
    • Consent enrollment note in CPRS
    • Informed consent document scanned in CPRS
preparing for the participant review portion of the audit
Preparing For The Participant Review Portion of the Audit
  • Treat each patient as if he/she will be audited
  • Make the research interventions an obvious portion of the patient’s chart
  • Use documentation templates for enrollment, progress notes, and termination
  • Provide complete documentation of clinical care and the rationale for protocol deviations or exemptions
  • Document assessment of AEs and reporting of UPIRSOs
audit of regulatory files
Audit of Regulatory Files
  • IRB correspondence
    • Initial and continuing review approval letters
    • Waivers and authorizations
  • R&D correspondence
    • Initial and continuing review approval letters
    • Clinical impact statements
    • Data security checklist
    • Research protocol safety survey
  • Sponsor correspondence
    • Exemptions
    • Queries
    • Changes in conduct of the study

List in not intended to be all inclusive

audit of regulatory files cont
Audit of Regulatory Files (cont)
  • Protocol
    • Approved versions of the protocol
    • Protocol amendments
    • Investigator brochures
  • Continuing review
    • Progress reports
    • DSMB minutes and reports
  • Informed consent
    • All versions of IRB approved informed consent documents

List in not intended to be all inclusive

audit of regulatory files cont26
Audit of Regulatory Files (cont)
  • Participant enrollment
    • Screening log
      • Reason not enrolled if screen failure
    • Enrollment log
      • Name
      • Last four
      • Assigned study number
      • Date informed consent was signed
      • Enrollment date
      • Termination date
    • Must be able to account for each signed informed consent

List in not intended to be all inclusive

audit of regulatory files cont27
Audit of Regulatory Files (cont)
  • Patient safety and monitoring
    • Data Safety and Monitoring Plan
      • Adverse event monitoring and summaries
      • Notes to file
    • Reported UPIRSOs
    • IND safety reports
    • PBM alerts
      • Note to file for the PIs assessment and actions

List in not intended to be all inclusive

audit of regulatory files cont28
Audit of Regulatory Files (cont)
  • Drug/device accountability
    • All versions of 1572 if applicable
    • Shipment receipts
    • Inventory logs
    • Dispensing log if not maintained by pharmacy
    • 10-9012 Investigational Drug Information forms
    • Contract if drugs are stored outside research pharmacy (rare instances)
  • Laboratory
    • Certifications
    • Normal values
    • Lab director CVs

List in not intended to be all inclusive

audit of regulatory files cont29
Audit of Regulatory Files (cont)
  • Investigators and study staff
    • CVs signed and updated within 2 years
    • Medical / professional licenses
    • Certificates of training
    • Scopes of practice
    • Responsibility and signature logs
    • COI disclosure forms
  • Monitoring
    • Monitor sign in log
    • External monitor reports

List in not intended to be all inclusive

hierarchy of audit problems
Hierarchy of Audit Problems
  • I-words
    • Informed consent
    • Ineligibility
    • IRB
    • IND
  • D-words
    • Drugs
    • Documentation
    • Diagnostic studies
  • F-words
    • Follow-up
    • Forms
    • pro Forma (practices that seek to satisfy the minimum requirements)
standard operating procedures sops
Standard Operating Procedures (SOPs)
  • Informed consent process
  • Handling of body fluids / tissue samples
  • Protocol coverage when PI is unavailable
  • Maintaining participant confidentiality
  • Handling participants’ comments, complaints, or concerns
  • Unblinding procedures

List in not intended to be all inclusive

investigator audit report
Investigator Audit Report
  • Summary of visit
    • Recommendations for improving practice
    • Action plan if necessary
    • Timelines for achieving compliance
    • Follow-up if required

AuditReports Should Provide

  • A process for Principal Investigators to respond
  • Communication with responsible administrator
  • Confidentiality
  • Triggering of educational process as needed
  • Appropriate committee reporting, review and action if needed
following the audit
Following The Audit
  • Re-examine strengths and weaknesses in your individual program
  • Address any issues in a written response to the audit findings
    • Including findings that may have been erroneous or require clarification
  • Use this as a time to improve your research program

VA Compliance Office

    • Kari Williams, Research Compliance Officer
    • Pam Cervantez, Research Compliance Coordinator
    • Joanne Gonzales, Research Compliance Auditor
  • UTHSCSA Compliance Office
    • Gayle Knight, Assistant Vice President for Regulatory Affairs and Compliance
    • Anna Taranova, Manager of Clinical Study Monitors