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Common Mistakes & Audits. Summary of audit findings by category. Common Mistakes. Delegating responsibility rather than authority The PI is always responsible for all study activity and for all personnel performance Lesson to be learned.PI - PowerPoint PPT Presentation

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Division of Clinical Research

Common Mistakes & Audits05/21/2014

Summary of audit findings by categoryCommon MistakesDelegating responsibility rather than authorityThe PI is always responsible for all study activity and for all personnel performance

Lesson to be learned.PIPick your sub-investigators and coordinators carefully!Common MistakesInformed ConsentThis is the Achilles heel of research and is the most commonly cited in litigationCommon MistakesNot keeping the IRB informed of study changes and updates Especially in sponsored research we have a sponsor that continually monitors study activity- it is a common mistake to notify the sponsor of problems and forget to notify the IRBCommon TTUHSC Audit FindingsDiscrepancies in executed Informed Consent Documents, such as:Person signing as PI/Authorized Representative is not authorized to signPI/Authorized Representative fails to datePI/Authorized Representative signature date different than Subject signature dateMost recent IRB-approved Informed Consent Document not utilized (old form is used)Common TTUHSC Audit Findings

Common TTUHSC Audit FindingsSerious Adverse Events not reported to the IRB promptly (for example, SAE reporting to the IRB done months later at the request of the sponsor)No source documentation available to verify that the subjects received a copy of the Informed Consent DocumentSigned original Informed Consent Documents not consistently stored in the same location (for example, a majority of originals are found in the individual subject binders and a few originals are found in the medical record)Investigators and/or research staff lacking TTUHSC human research protection training and/or HIPAA for Researchers trainingFailure to submit amendments to the IRB regarding protocol modifications or changes in investigators and research staff

Common TTUHSC Audit FindingsSubject reimbursement procedures.Non-research staff involved in the research process.

Sponsor AuditsPurpose: to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and applicable regulationsA sponsors audit is independent and separate from routine monitoring or quality control functionsShould be done by individuals who are independent of the clinical trials/systems-regular Monitor cant do them.

FDA AuditsPurpose: To ensure compliance

Type of AuditsStudy-directed auditsInvestigator-directed auditsFor cause auditsNot for cause audits-routine surveillanceWhat FDA Looks ForWho did whatDegree of delegationWhere study was performedHow/ where data were recordedDrug accountabilityMonitor contact & follow-up lettersData audit

FIRST binder they ask for may be correspondence! Recent FDA FindingsInclusion of individuals that did not meet the inclusion criteria.Continuing of individuals that should have been removed from the study.Study procedure errors (not following the study roadmap)Errors in dosingCommunication errors

What if the FDA shows up?Do NOT panic!Ask for their ID and Form 482Give them ONLY what they specifically ask forTry never to leave them alonePut them in a room that has no other study materialsBe honest and helpfulNotify the Human Research Protection Office (HRPO) at TTUHSC-In advance if possibleNotify the study sponsor-in advance if possible

FDA AuditsFDA 482-Notice of Inspection (theyre coming)FDA 483-Audit findings (BAD! Issued if they note some kind of problem, you may or may not get a warning (action) letter with it) Establishment Inspection Report (EIR). This is an overall report of their visit-youll always get this. Action Letters: NAI-No Action IndicatedVAI-Voluntary action indicatedOAI-Other action indicated

The Corrective Action PlanPI MUST take responsibilityDo not play the Pass the Blame Game!Address each issue directly Enlist the help of your sponsor and local compliance team

FDA Regulatory SanctionsFormal disqualificationClinical holdVoluntary restrictionsCriminal prosecution

Long-term consequencesAudit results are publicly accessible on the FDA websiteOnly bad conduct makes the news-front pageMost pre-study questionnaires from sponsors ask if youve ever been audited, received a 483. If you have they want a copy.Effects your reputation in the clinical research arenaYour commitment & ethics may be questionedPoints to RememberAudit Findings/Common Mistakes The Informed Consent is most commonly cited in research litigation

The PI is always responsible for all study activity and for all personnel performance

Keep the IRB informed of all study changes and updates

QUESTIONS?Chart31171591310640

OtherDisrepancies in Subject DataDeviations from Good Clinical PracticeLack of Required TrainingErrors made by IRBDiscrepancies in Reporting Adverse Events to IRBPersonnel Changes Not Reflected in Study DocumentationProtocol DeviationsDiscrepancies in Documentation of Informed Consent

Sheet1DateIRB No.PI Last NameFirst NameDepartment/Org.CampusRisk# Subjects EnrolledType of AuditStudy TitleCommentsF/UClose DateICDDataGCPTrainingOtherFormsIRB errorsAE reportingPersonnelProt. Dev.5/15/031852Desai, MDPrakashAmarillo Heart GroupAmarilloHigh24SpecialGuidant (COMPANION) Comparison of Medical Therapy, Pacing & Defibrillation in Heart FailureIRB request - wrong ICF signed6/11/036/11/03115/21/03L03-115Zumwalt, MDMimiOrthopaedic SurgeryLubbockMinimal0SpecialStrength and Conditioning Program in Junior High and High School AthletesChaffin request; IRB approved 6/11/036/11/036/11/0315/29/0301044Schiffer, MDRandolphNeuropsychiatryLubbockModerate7SpecialEfficacy and safety of a flexible dose of Risperidone versus placebo in the treatment of Psychosis of Alzheimers DiseaseAllegations received, no significant findingsNone6/13/0325/29/0399169Schiffer, MDRandolphNeuropsychiatryLubbockExpedited98SpecialNeuropsychiatric Research DatabaseAllegations received, no significant findingsNone6/13/035/30/031022Schiffer, MDRandolphNeuropsychiatryLubbockExempt40SpecialExperiment II: A Prevalence Study of Neuropsychiatric Disease in Two ColoniasAllegations received, all ICFs invalid, must re-consent8/30/0310/8/03316/3/03E02014Guerrero, MDMartinNeuropsychiatryEl PasoMinimal21RoutineAlzheimers Disease in El Pasos Residential Elderly Population7/11/037/11/0316/4/0300190Jumper, MDCynthiaInternal MedicineLubbockModerate7RoutineClinical trial of low dose oral interferon alpha in Idiopathic Pulmonary Fibrosis7/11/037/11/03216/20/031973Paullus, MDWayneSouthwest Neuroscience and Spine CenterAmarilloMinimal18SpecialClinical Outcome of Lumbar Degenerative Disc Disease Treated with PLIF Allograft SpacerCITI and corrective action plan due 7/31/03 to lift suspension7/31/038/7/03131117/2/031145Oud, MDLaviInternal MedicineOdessaHigh6SpecialA Double-Blind, Placebo-Controlled, Study of E5564, A Lipid A Antagonist Administered by Twice Daily Intravenous Infusions in Patients with Severe SepsisEisai closed enrollment Sept 2003; Waiting for final closure from sponsor as of 1/7/20042/15/049/12/03118/6/03L03-001Oud, MDLaviInternal MedicineOdessaModerate3SpecialEfficacy and Safety of Drotecogin Alfa (Activated) in Adult Patients with Early Stage Severe SepsisNone8/7/03118/6/03L03-061Oud, MDLaviInternal MedicineOdessaExempt62SpecialEliciting patients advance directives for life-sustaining interventions: education and practice of Internal Medicine post-graduate trainees in the state of TexasNone8/7/038/6/03L03-075Oud, MDLaviInternal MedicineOdessaExempt0SpecialEvaluating the Achievement of Target Blood Pressure in Diabetic Patients in the Primary Care SettingStudy needs to be closed. Still not closed as of 1/7/20042/15/048/6/03L03-130Oud, MDLaviInternal MedicineOdessaExempt0SpecialAppropriateness of Intra-thoracic position of Central Venous Catheter Tips: Impact of Different Radiological Reference MethodsNone8/7/038/22/0395134ACobos, MDEverardoInternal MedicineLubbockModerate11RoutineTotal Body Irradiation, Etoposide, Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation Followed by Randomization to Therapy with Interleukin-2 Versus Observation for Patients with Non-Hodkins Lymphoma, A BMT Study, Phase IIIRequested changes made to ICD1/7/041/7/04218/29/032018Naqvi, MDMubarizPediatricsAmarilloModerate4RoutineA phase III, double-blind, randomized, comparative, multicenter study of the immunogenicity and safety of the three doses of GlaxoSmithKline Biologicals thimerosal-free hepatitis B vaccine compared to the US-licensed GlaxoSmithKline Biologicals preservReceived and accepted Corrective Action Plan dated 11/5/200312/19/0312/19/0314129/11/03E03008Zevallos, MDJuanCenter for Border HealthEl PasoMinimal221RoutineChronic Disease Risk Assessment and Intervention Among El Paso Farm WorkersReceived and accepted Corrective Action Plan dated 10/1/200310/16/0310/16/03119/23/03L03-041Ho, MDMatthewOB/GYNOdessaMinimal2SpecialA Multi-centered, Randomized, Parallel-group, Investigator-blinded Study to Compare the Safety and Efficacy of MONISTAT 1 Combination Pack in Nighttime versus Daytime AdministrationNone10/16/031119/23/0399095Ho, MDMatthewOB/GYNOdessaMinimal65SpecialUltrasonic Assessment of Residual Urine Volume to Postvaginal Surgery PatientsEdward Ofori is not listed as Co-investigator & Carrie Relyea needs to be removed as of 1/16/2004. CR was due 1/14/2004. Check Feb IRB meeting2/15/04119/23/03L03-113Baldwin, PhDDavidResearch AdministrationOdessaMinimal274SpecialA prospective study of osteoporosis screening in postmenopausal women in West TexasReceived and accepted Corrective Action Plan dated 10/30/200311/12/0311/12/03119/23/031093Baldwin, PhDDavidResearch AdministrationOdessaExpedited271SpecialBone Density in a Select Premenopausal Mexican-American PopulationReceived and accepted Corrective Action Plan dated 10/30/200311/12/0311/12/0311110/14/032196TsikourisJamesPharmacyLubbockModerate19Routine"ACE INHIBITORS VERSUS