HSPO Monitoring Visit/Audit

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HSPO Monitoring Visit/Audit

• Monika Haugstetter, RN, MHA, MSN
• Judy Gaffney, BA
• HSPO/IRB
• University of Connecticut Health Center

http//resadm.uchc.edu/hspo/index.html
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Audit Purpose

• Management tool to monitor conduct of research
  studies IRB review process
• Promote Education concerning policies
  regulations
• Promote Quality Research
• Monitor/improve compliance w/ policies
  regulations
• Optimize Protection for Subjects, PI UCHC

http//resadm.uchc.edu/hspo/index.html
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Types of Monitoring Visits/Audits

• Random (automatic system for selection
  scheduled)
• Unannounced
• IRB Mandated (unannounced or short-notice)
• For Cause (e.g. response to complaint
  unannounced or short-notice)
• Follow-up audit to assess implementation of
  corrective actions (scheduled)
• Pre-IRB approval IND audit (investigator-initiated
  INDs scheduled)
• Observation of Informed Consent Process

http//resadm.uchc.edu/hspo/index.html
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Random Audit Process

• Selection
• Audit Notification Scheduling Date/Time
  Arrangements
• Audit interview/material review
• Audit letter/report (may require PI response)
• Submission of corrective action plan if
  applicable
• Referral to IRB if necessary
• Audit final follow-up letter if applicable

http//resadm.uchc.edu/hspo/index.html
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Random Audit Notification

• Standard electronic letter/message to PI
• Arrangement of Date/Time Visit
• Thorough study review (Audit Intake Form)
• IRB File
• Adverse Events System
• IRB Minutes
• Proof of CITI Training

http//resadm.uchc.edu/hspo/index.html
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Audit

• Interview w/ studys PI/designee
• Advertisements/Recruitment
• Enrollment/Recruitment/Screening (eligibility,
  number, diversity, etc)
• Consent Process
• Payments, waivers, ICF copy for subjects
• Study Drug / Device Accountability
• Storage/maintenance of data

http//resadm.uchc.edu/hspo/index.html
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Audit

• Brief interview w/ Pharmacy, Laboratory,
  Radiology Departments if applicable
• Review of storage of study documents materials
  (samples, devices, specimens)

http//resadm.uchc.edu/hspo/index.html
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Audit

• Review of Study Drug/Device Procedure
  /Documentation
• Pharmacy arrangements if applicable
• Orders/prescriptions
• Administration/use
• Chart Notes
• Drug/Device accountability logs
• Storage labeling
• Return of drug or disposition

http//resadm.uchc.edu/hspo/index.html
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Audit

• Review of Consent Process
• Informed Consent Form (required optional
  elements)
• Subjects ICFs (3-6 records)
• Names of subjects consenter/witness/parent or
  legally authorized representative/assent
• Signatures dates, no blank fields
• Valid HIPPA Authorization form
• Re-consenting documented (if applicable)

http//resadm.uchc.edu/hspo/index.html
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Audit

• Review of all study related documents
• Regulatory/study binder
• All submissions (initial, continuations,
  modifications)
• Letters of Approval
• Protocols Amendments
• ICFs HIPPA Authorization Forms
• Recruitment materials/subject letters

http//resadm.uchc.edu/hspo/index.html
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Audit

• Review of all study related documents (cont.)
• Study Instruments/Surveys/Questionnaires
• Data Collection Forms (CRFs)
• Personnel responsibilities/delegation/signature
  logs (required if FDA oversees)
• FDA 1572 (if applicable)
• Advertisement/flyers
• Correspondence

http//resadm.uchc.edu/hspo/index.html
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Audit

• Review of all study related documents (cont.)
• DSMP/DSMB
• Charter
• Proof of training for research personnel
• SAE reports
• Deviation Log
• Problem Reports

http//resadm.uchc.edu/hspo/index.html
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Audit

• Review of all study related documents (cont.)
• Internal/External Visits/Audits Reports
• Sponsor/MedWatch reports
• Conflict of Interest (COI) Forms
• Copy of certificates licenses
• Form designating back-up PI if desired
• PI back-up PI professional CV/ NIH sketch

http//resadm.uchc.edu/hspo/index.html
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Audit

• Review of Subject Charts (3-6 records)
• ICF/HIPAA
• Eligibility
• Treatment
• Study Calendar/Visit schedule
• Deviations
• Data quality/source documentation
• AE/SAE
• Data Security (labeling, codes)
• Payments/Compensation

http//resadm.uchc.edu/hspo/index.html
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Audit letter/report

• Identifies describes deviations/non-compliance
  and/or substantive deficiencies
• Identifies areas of strength best practices
• Provides requirements for corrective action plans
  
• Presents educational points recommendations
• Usually issued 5-10 business days following audit
• Electronic Copy no hard copies sent out
• Letter cc to distribution list

http//resadm.uchc.edu/hspo/index.html
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Corrective Action Plan Follow-up

• Corrective action plans/modification requests if
  needed
• PIs written response due date stated in audit
  letter
• PIs response to DHSPO directly to Research
  Compliance Monitor (RCM)
• Final audit follow-up letter
• Electronic Copy no hard copies sent out

http//resadm.uchc.edu/hspo/index.html
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Serious and/or Continuing Non-Compliance

• Findings involving imminent risk to subjects
  immediately reported to DHSPO
• If Findings Suggest Possible Serious and/or
  Continuing Non-Compliance
• Referred to IRB for review, discussion
  determination after final PI response is received
  
• Findings may be reported out (e.g. institutional
  officials, FDA, funding agency, OHRP)

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Minimizing Non-Compliance

• Maintain Accurate Documentation
• Dates times
• Appropriate signatures
• Utilization of documents w/ valid-through dates
• No blank fields on forms (use N.P. or N/A )
• Appropriately filled-out forms
• Source Documentation/CRFs

http//resadm.uchc.edu/hspo/index.html
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Pointers

• Ensure Consistency between all study documents
  (protocol, IRB application, ICF, etc.)
• Ensure Consistency between regulatory documents
  at study site in IRB file
• Modifications must be approved by IRB prior to
  implementing any changes

http//resadm.uchc.edu/hspo/index.html
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Remember

• Follow protocol
• Conduct study as planned, described in IRB
  application explained/approved by IRB
• If changes needed, submit for modification
• Self-report deviations unanticipated problems
• Follow through on corrective action plans
• If in doubt, ask HSPO staff

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Contact Information

• IRB support
• Patty Gneiting (exempt/expedited) x4849
• Pam Colwell (panel 1 3) x1019
• Donna Horne (panel 2 3) x4851
• Marcy Chasse (outgoing approvals) x8729
• HSPO
• Deputy Director, Deb Gibb x3054
• Judy Gaffney, RCM x7555
• Monika Haugstetter, RCM x8802

http//resadm.uchc.edu/hspo/index.html