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HSPO Monitoring Visit/Audit

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. Audit Purpose. Management tool to monitor: conduct of research studies & IRB review process

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HSPO Monitoring Visit/Audit

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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Audit • Interview w/ study’s 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. Corrective Action Plan & Follow-up • Corrective action plans/modification requests if needed • PI’s written response due date stated in audit letter • PI’s 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

  17. 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)

  18. 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

  19. 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

  20. 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

  21. 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

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