Presentation on theme: "Briefing on MHRA routine inspection of non-commercial clinical trials"— Presentation transcript:
1Briefing on MHRA routine inspection of non-commercial clinical trials Routine Good Clinical Practice (GCP) MHRA Inspection, University of Aberdeen 2011
2Aims MHRA inspections MHRA inspection at University of Aberdeen How should staff prepare?Advice for staff on key areas of weaknessSo that:You can identify and address any actions requiredYou can participate in the interviews with confidenceUniversity of Aberdeen can demonstrate that clinical trials are following current legislation and are conducted to high safety and quality standards.
3Why do the MHRA Inspect?EU directive 2001/20/EC transposed into UK law May 2004 as Medicines for Human Use (Clinical Trials) Regulations 2004Legal obligation to conduct Clinical Trials of Investigational Medical Products (CTIMPs) to Good Clinical Practice (GCP).MHRA is statutory body responsible for compliance with UK regulationsMHRA inspect (CTIMPs) on humans covered by the regulations
43 Types of MHRA Inspection RoutineTriggeredRequestedUniversity of Aberdeen inspection is routineProvisionally 4 days week of 20 June 2011
5Who do the MHRA inspect?Legally able to inspect all organisations ‘sponsoring’ or ‘hosting’ clinical trials in the UKIncludes commercial and non-commercial organisationsAdapt inspection to organisation typeRoutine inspections focus on systems
6What do the MHRA inspect? University has systems in place to support conduct of CTIMPs in compliance with regulations (and GCP).Specific examples of CTIMPs to demonstrate those systemsAreas of interest include:Approval processes and regulatory submissionsContract ManagementTrial file and data managementQuality assurance and monitoringTrainingIT systemsPharmacovigilanceArchivingLaboratoriesPharmacy
7What happens before the inspection? University notified by MHRA of inspection 4th February 2011Dossier sent to MHRA on 4th March Including a list of CTIMPs (live and complete) to give an overview of clinical trial activity.MHRA provide draft agenda approx 6 weeks prior to the inspectionTeleconference to finalise agenda approx 2 weeks prior to inspectionUniversity will coordinate the inspection
9What are we doing to prepare? MHRA Inspection Internal Working GroupGap analysis and action planMonitoring and AuditInforming staff of the inspectionStaff training – GCP
10What are the key areas of weakness? Qualifications and trainingCommunicationDelegation of dutiesStandard Operating ProceduresEvidencing of informationStudy file and filingPharmacovigilanceInformed ConsentEquipmentStudy closure and archiving
11PharmacovigilanceSponsor responsibility to ensure events are reported in accordance with regulations.Currently have central reporting (documented in CI delegation letter) .New SOP to be issued with updated process
12Monitoring/AuditSponsored studies will be audited to ensure that essential documents are present in the Trial Maser File.Training record will be required for trial personnel on a study delegation log.
13What can you do to prepare? Handout available with recommendations for addressing key areas of weakness.SOPs for maintaining a Trial Master File, Investigator Site File, Pharmacovigilance will be available soon
14What happens during the inspection? Opening meeting – inspectors present inspection planDocument review – including medical notesInterviews with selected staffTour of facilitiesAdditional requestsClosing meeting – summary of findings and provisional grading
15Interviews with study personnel on study conduct These assess knowledge of GCP and regulatory requirements, and probe for evidence of robust processes for ensuring compliance with GCPYou should read through the example questions and answers provided.
16Common Themes During Interview: TrainingCommunicationSafety reportingProtocol procedures & adherenceInvestigational medicinal product handlingInformed consentApproval process including amendmentsAnnual reports to ethics/MHRAStatistics and data handlingOut of hours/leave coverRandomisation & un-blinding proceduresEnd of trial & archiving procedures
17Dos and Don’ts during Interview Be honest - we know we have some gaps and are addressing them - failure to recognize the gaps is more problematic than acknowledging the gapsAvoid being confrontational - esp. avoid giving the impression that this is ‘bureaucratic detail’Be ‘alert’ to areas of improvementAvoid being defensive.
18Dos and Don’ts during Interview Only answer the question askedIf mistakes are made or wrong answers given, correct them at an appropriate time, or ensure somebody else does so.Try your best to correct any deficiencies noted by the inspectors before they leaveDemonstrate confidence in your trial systems and data – you know it best.Be positive.
19Dos and Don’ts during Interview Should inspection findings be made, make sure that you understand them completely – it is easier to ask the inspector for clarification during the inspection rather than after the report is issued.Don’t volunteer informationIt is appropriate to challenge a finding made by an inspector if you are certain they are incorrect, but do not persist in your objection.
20What happens after the inspection? MHRA to report issues within 30 days of the inspection, summarising findings.University response will include an action plan, timelines to address any findings.MHRA receive response - will issue a closing letter and GCP Inspection Statement.Future inspections will be performed at a frequency determined by the MHRA.Possible routine GCP inspection of NHS Grampian
21Summary Review your trial documentation and training files for staff. Have evidence of training (GCP certificate, CV)Ensure you can explain your role in the trialReview the typical questions and answers providedFamiliarise yourself with new SOPs when availableBe confident of your trial and processes. Remember that you know your trial better than anyone else.
22Any Questions? Main Contacts: Prof Phil Hannaford –Prof Alison MacLeod –Dr Gail Holland –Tel:Lynda Sime –Tel: