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New Research Service Standard Operating Procedures

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  • 1. New Research Service StandardNew Research Service Standard Operating ProceduresOperating Procedures Kimberly Summers, PharmDKimberly Summers, PharmD Assistant Chief for Clinical ResearchAssistant Chief for Clinical Research South Texas Veterans Health Care SystemSouth Texas Veterans Health Care System Research & Development ServiceResearch & Development Service
  • 2. Standard Operating ProceduresStandard Operating Procedures • External Clinical Research MonitoringExternal Clinical Research Monitoring VisitsVisits • Subject Recruitment and AdvertisingSubject Recruitment and Advertising • Clinical Impact StatementsClinical Impact Statements
  • 3. Monitoring By External AgenciesMonitoring By External Agencies • Entities external to the facilityEntities external to the facility – Pharmaceutical companiesPharmaceutical companies – Study sponsorsStudy sponsors – Contract Research Organizations (CROs)Contract Research Organizations (CROs) – VA Cooperative Studies Program MonitorsVA Cooperative Studies Program Monitors • Site visitsSite visits – RoutineRoutine – Conducted for specific causeConducted for specific cause
  • 4. External Clinical ResearchExternal Clinical Research Monitoring VisitsMonitoring Visits • VHA Memorandum From Chief ResearchVHA Memorandum From Chief Research and Development Officerand Development Officer – Thru Deputy Under Secretary for HealthThru Deputy Under Secretary for Health – Subject: Reporting of All Study Site-Subject: Reporting of All Study Site- Monitoring Visit ResultsMonitoring Visit Results – Charge: Each research office must developCharge: Each research office must develop procedures that will ensure all serious findingsprocedures that will ensure all serious findings and concerns are appropriately addressedand concerns are appropriately addressed and the appropriate facility officials andand the appropriate facility officials and committees are notifiedcommittees are notified
  • 5. Research Office NotificationResearch Office Notification • Findings and issues of concern must beFindings and issues of concern must be forwarded to appropriate facility officials andforwarded to appropriate facility officials and committeescommittees – This is the responsibility of the Research officeThis is the responsibility of the Research office – Component of the STVHCS Human SubjectsComponent of the STVHCS Human Subjects Protection Program (HRPP)Protection Program (HRPP) • If no serious findings or concerns are identified,If no serious findings or concerns are identified, the Research office must be notified in writingthe Research office must be notified in writing that there were no such findingsthat there were no such findings
  • 6. Why is Compliance with this Memorandum Important?
  • 7. Office of Research Oversight (ORO) • Primary VHA office in advising the Under Secretary forPrimary VHA office in advising the Under Secretary for Health on all matters of compliance and assuranceHealth on all matters of compliance and assurance including:including: – Human subject protectionsHuman subject protections – Animal welfareAnimal welfare – Research safety and securityResearch safety and security – Research data securityResearch data security – Research misconductResearch misconduct • Oversight is enforced by:Oversight is enforced by: – Performing periodic prospective and for-cause reviewsPerforming periodic prospective and for-cause reviews – Conducting investigationsConducting investigations – Assuring compliance with the laws, regulations, and policiesAssuring compliance with the laws, regulations, and policies applicable to VHA research.applicable to VHA research.
  • 8. Local Example • Research office unaware of serious issues identified by external study monitors for a VA- approved research protocol • Corrective actions were not put into place • Serious consequences for the institution and investigator resulted
  • 9. Upon Notice of Monitoring VisitUpon Notice of Monitoring Visit • Research staff scheduling or confirming theResearch staff scheduling or confirming the monitoring visit must notify the Research officemonitoring visit must notify the Research office – For scheduled monitoring visits notification should beFor scheduled monitoring visits notification should be by email toby email to KimberlyK.Summers@va.govKimberlyK.Summers@va.gov – For unscheduled monitoring visits notification may beFor unscheduled monitoring visits notification may be by phone (210) 617-5123 directed to Kimberlyby phone (210) 617-5123 directed to Kimberly Summers, Assistant Chief for Clinical ResearchSummers, Assistant Chief for Clinical Research • Notification should be made as soon as studyNotification should be made as soon as study personnel are aware of the visitpersonnel are aware of the visit
  • 10. At The Time Of The Monitoring VisitAt The Time Of The Monitoring Visit • Study monitor must sign in at the ResearchStudy monitor must sign in at the Research Office and receive a visitor badgeOffice and receive a visitor badge – Check-in at Room Q202.1Check-in at Room Q202.1 – A Research Monitor Log will be maintained by theA Research Monitor Log will be maintained by the Research OfficeResearch Office • Study monitor will be providedStudy monitor will be provided – External Monitor Agreement FormExternal Monitor Agreement Form • Must be reviewed and signed at the time of check inMust be reviewed and signed at the time of check in – STVHCS Report of Clinical Research Monitoring VisitSTVHCS Report of Clinical Research Monitoring Visit • Must be returned to the Research officeMust be returned to the Research office
  • 11. External Research Monitor Log
  • 12. Visitor Badges • Badges will be issued in exchange for a picture ID • Badge must be worn at all times • Badges must be returned to the Research office by 4:30pm – If monitors will be conducting business past 4:30pm they should return to the Research office prior to 4:30 for their state issued ID and the responsible investigator or study staff must ensure the badge is returned the next business day • Lost or stolen badges will be assessed a $25 fee to the responsible investigator • Monitors assigned the visitor badge must be accompanied by a VA employee (paid or WOC)
  • 13. • CompletionCompletion is requiredis required independentindependent of theof the findingsfindings associatedassociated with the visitwith the visit
  • 14. Findings That Require an Exit InterviewFindings That Require an Exit Interview • Suspicions or concerns that serious non-Suspicions or concerns that serious non- compliance may existcompliance may exist • All findings of serious non-compliance withAll findings of serious non-compliance with study protocol, IRB requirements orstudy protocol, IRB requirements or applicable regulations and policiesapplicable regulations and policies • Monitoring visits conducted by regulatoryMonitoring visits conducted by regulatory agencies (FDA, OHRP)agencies (FDA, OHRP)
  • 15. Compliance With External ClinicalCompliance With External Clinical Research Monitoring Policies and SOPsResearch Monitoring Policies and SOPs • STVHCS Compliance OfficeSTVHCS Compliance Office – Will verify results of external clinical research monitoring visitsWill verify results of external clinical research monitoring visits were reported to the R&D Officewere reported to the R&D Office – Component of routine monitoring of investigator recordsComponent of routine monitoring of investigator records • Office of Research Oversight (ORO)Office of Research Oversight (ORO) – May perform periodic prospective and for-cause reviews toMay perform periodic prospective and for-cause reviews to assure compliance with the laws, regulations, and policiesassure compliance with the laws, regulations, and policies applicable to VHA researchapplicable to VHA research • STVHCS PoliceSTVHCS Police – Will audit appropriate security measures are in place for allWill audit appropriate security measures are in place for all visitors related to researchvisitors related to research – Will audit check-in and assignment of badgesWill audit check-in and assignment of badges
  • 16. Human Subjects ClinicalHuman Subjects Clinical Research Recruitment andResearch Recruitment and AdvertisingAdvertising
  • 17. Recruitment • “Researcher Contact with Veterans” – VHA Memorandum 7/10/06 • IRB-approved mechanisms – Physician referral – Posting of IRB-approved advertisements • “Preparatory to Research” by HIPAA Privacy Rule – VA guidelines are more restrictive
  • 18. Researcher Contacts with Veterans • All non-essential contact of veterans must stop – Clinically essential contact that cannot be deferred is allowed – Contact shall not solicit sensitive information • Contact by researchers and study staff must be limited to procedures and data elements outlined in IRB and R&D approved protocols • During recruitment – Initial contact must be in person and/or by letter – A telephone number must be provided for the veteran to verify the validity of the study – http://www.clinicaltrials.gov/ website may be provided • Following recruitment and during follow-up – All telephone calls should begin by referring to previous contacts and information provided in the informed consent document 7/10/06 Principal Deputy Under Secretary for Health Memorandum
  • 19. Physician Referral • Veteran patients may be formally referred from VA staff for a VA-approved research protocol • Veteran patients may NOT be formally referred from VA staff to off-site locations for non-VA approved research protocols – Veteran patients have a right to seek care from and enroll in research studies outside the VA – Informing veteran patients of the availability of an outside research study is not considered a referral, if the referring physician will not have ongoing participation in the care of the patient
  • 20. Informing Veterans About Off-site Non-VA Research Studies • Veterans must be informed that VA will not be responsible for any costs related to their care as part of the off-site research • Enrollment should occur through the veterans’ own initiative in contacting the study personnel at the off-site institution • Provision of information to a veteran regarding off-site research and their associated responsibility for cost should be documented by the VA physician in a progress note in CPRS • VA records may not be accessed to obtain information for research purposes of a non-VA off-site study
  • 21. Recruitment AdvertisementsRecruitment Advertisements Posted at the STVHCSPosted at the STVHCS • Steps requiredSteps required – Approved and stamped by UTHSCSA IRBApproved and stamped by UTHSCSA IRB – Verification of active protocol and stamped by VAVerification of active protocol and stamped by VA Research OfficeResearch Office – Posting approval by VA Public Affairs OfficePosting approval by VA Public Affairs Office • Recruitment of VA patients into non-VA studiesRecruitment of VA patients into non-VA studies through posted advertisements in NOT allowedthrough posted advertisements in NOT allowed
  • 22. Expedited PostingExpedited Posting • Following IRB approval Investigator or studyFollowing IRB approval Investigator or study staff may hand deliver advertisementstaff may hand deliver advertisement – R&D officeR&D office • RM Q202RM Q202 • Will verify study approval and stampWill verify study approval and stamp – Public Affairs officePublic Affairs office • RM 118RM 118 • Will approve and stamp for postingWill approve and stamp for posting – May be posted same dayMay be posted same day
  • 23. “Preparatory to Research” • Review of individually-identifiable information by a VA investigator to prepare a research protocol does not require IRB or R&D approval • Examples: to generate a hypothesis, determine feasibility to conduct a study, determine the number of eligible patients • In the VA, using individually-identifiable information to contact potential research subjects as part of recruitment into a research protocol is NOT considered “preparatory to research” – VA regulations differ from those described in the HIPAA Privacy Rule – IRB and R&D Committee review and approval required – IRB approved waiver of authorization and waiver of informed consent required • Pilot studies are NOT considered part of the activities “preparatory to research” – IRB and R&D Committee review and approval required
  • 24. Statement of Clinical ImpactStatement of Clinical Impact FormsForms
  • 25. R&D Committee Review of Research • The R&D Committee must evaluate the availability of adequate resources to conduct and complete the research – Clinical hospital services must be notified if their services are required in order to conduct a research project – Each affected service must verify resources within their respective service are adequate to conduct and complete the research project
  • 26. Statement of Clinical ImpactStatement of Clinical Impact • Radiology Service • Nuclear Medicine Service • Nursing Service • Pharmacy Service • Pathology and Laboratory Service • Other Hospital Service
  • 27. • Electronic formElectronic form available onavailable on Research websiteResearch website • Items 1-7Items 1-7. All fields. All fields are required.are required. InformationInformation entered on page 1entered on page 1 will be auto filledwill be auto filled on pages 2 throughon pages 2 through 6.6. • Item 8Item 8. Complete. Complete the applicable tablethe applicable table for each VAfor each VA Service that will beService that will be utilized as part ofutilized as part of your project.your project.
  • 28. Routing Statement of ClinicalRouting Statement of Clinical Impact FormsImpact Forms • Submit completed forms via email toSubmit completed forms via email to stxresearch@va.govstxresearch@va.gov • If you have any questions completing the formIf you have any questions completing the form – Contact Angela Casas in the Research office at (210)617-5300Contact Angela Casas in the Research office at (210)617-5300 x 15523x 15523 • The Research office will forward completed forms toThe Research office will forward completed forms to the appropriate VA Services for signaturesthe appropriate VA Services for signatures • An electronic signed copy will be provided for yourAn electronic signed copy will be provided for your recordsrecords • If project requirements change for any VA Service, aIf project requirements change for any VA Service, a revised form must be submitted to the Research officerevised form must be submitted to the Research office
  • 29. Questions?Questions? Kimberly Summers, PharmDKimberly Summers, PharmD Office: (210) 617-5300 ext 15969Office: (210) 617-5300 ext 15969 Email: kimberlyk.Summers@va.govEmail: kimberlyk.Summers@va.gov