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Briefing on MHRA routine inspection of non- commercial clinical trials Routine Good Clinical Practice (GCP) MHRA Inspection, University of Aberdeen 2011.

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Presentation on theme: "Briefing on MHRA routine inspection of non- commercial clinical trials Routine Good Clinical Practice (GCP) MHRA Inspection, University of Aberdeen 2011."— Presentation transcript:

1 Briefing on MHRA routine inspection of non- commercial clinical trials Routine Good Clinical Practice (GCP) MHRA Inspection, University of Aberdeen 2011

2 Aims MHRA inspections MHRA inspections MHRA inspection at University of Aberdeen MHRA inspection at University of Aberdeen How should staff prepare? How should staff prepare? Advice for staff on key areas of weakness Advice for staff on key areas of weakness So that: You can identify and address any actions required You can identify and address any actions required You can participate in the interviews with confidence You can participate in the interviews with confidence University of Aberdeen can demonstrate that clinical trials are following current legislation and are conducted to high safety and quality standards. University of Aberdeen can demonstrate that clinical trials are following current legislation and are conducted to high safety and quality standards.

3 Why do the MHRA Inspect? EU directive 2001/20/EC transposed into UK law May 2004 as Medicines for Human Use (Clinical Trials) Regulations 2004 EU directive 2001/20/EC transposed into UK law May 2004 as Medicines for Human Use (Clinical Trials) Regulations 2004 Legal obligation to conduct Clinical Trials of Investigational Medical Products (CTIMPs) to Good Clinical Practice (GCP). Legal obligation to conduct Clinical Trials of Investigational Medical Products (CTIMPs) to Good Clinical Practice (GCP). MHRA is statutory body responsible for compliance with UK regulations MHRA is statutory body responsible for compliance with UK regulations MHRA inspect (CTIMPs) on humans covered by the regulations MHRA inspect (CTIMPs) on humans covered by the regulations

4 3 Types of MHRA Inspection Routine Routine Triggered Triggered Requested Requested University of Aberdeen inspection is routine University of Aberdeen inspection is routine Provisionally 4 days week of 20 June 2011 Provisionally 4 days week of 20 June 2011

5 Who do the MHRA inspect? Legally able to inspect all organisationssponsoring or hosting clinical trials in the UK Includes commercial and non-commercial organisations Adapt inspection to organisation type Routine inspections focus on systems

6 What do the MHRA inspect? University has systems in place to support conduct of CTIMPs in compliance with regulations (and GCP). University has systems in place to support conduct of CTIMPs in compliance with regulations (and GCP). Specific examples of CTIMPs to demonstrate those systems Specific examples of CTIMPs to demonstrate those systems Areas of interest include: Areas of interest include: Approval processes and regulatory submissions Approval processes and regulatory submissions Contract Management Contract Management Trial file and data management Trial file and data management Quality assurance and monitoring Quality assurance and monitoring Training Training IT systems IT systems Pharmacovigilance Pharmacovigilance Archiving Archiving Laboratories Laboratories Pharmacy Pharmacy

7 What happens before the inspection? University notified by MHRA of inspection 4 th February 2011University notified by MHRA of inspection 4 th February 2011 Dossier sent to MHRA on 4 th March Including a list of CTIMPs (live and complete) to give an overview of clinical trial activity.Dossier sent to MHRA on 4 th 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 inspection MHRA provide draft agenda approx 6 weeks prior to the inspection Teleconference to finalise agenda approx 2 weeks prior to inspection Teleconference to finalise agenda approx 2 weeks prior to inspection University will coordinate the inspection University will coordinate the inspection

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9 What are we doing to prepare? MHRA Inspection Internal Working Group MHRA Inspection Internal Working Group Gap analysis and action plan Gap analysis and action plan Monitoring and Audit Monitoring and Audit Informing staff of the inspection Informing staff of the inspection Staff training – GCP Staff training – GCP

10 What are the key areas of weakness? 1. Qualifications and training 2. Communication 3. Delegation of duties 4. Standard Operating Procedures 5. Evidencing of information 6. Study file and filing 7. Pharmacovigilance 8. Informed Consent 9. Equipment 10. Study closure and archiving

11 Pharmacovigilance Sponsor responsibility to ensure events are reported in accordance with regulations. Sponsor responsibility to ensure events are reported in accordance with regulations. Currently have central reporting (documented in CI delegation letter). Currently have central reporting (documented in CI delegation letter). New SOP to be issued with updated process New SOP to be issued with updated process

12 Monitoring/Audit Sponsored studies will be audited to ensure that essential documents are present in the Trial Maser File. Sponsored 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. Training record will be required for trial personnel on a study delegation log.

13 What 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

14 What happens during the inspection? Opening meeting – inspectors present inspection plan Opening meeting – inspectors present inspection plan Document review – including medical notes Document review – including medical notes Interviews with selected staff Interviews with selected staff Tour of facilities Tour of facilities Additional requests Additional requests Closing meeting – summary of findings and provisional grading Closing meeting – summary of findings and provisional grading

15 Interviews 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 GCP These assess knowledge of GCP and regulatory requirements, and probe for evidence of robust processes for ensuring compliance with GCP You should read through the example questions and answers provided. You should read through the example questions and answers provided.

16 Common Themes During Interview: Training Training Communication Communication Safety reporting Safety reporting Protocol procedures & adherence Protocol procedures & adherence Investigational medicinal product handling Investigational medicinal product handling Informed consent Informed consent Approval process including amendments Approval process including amendments Annual reports to ethics/MHRA Statistics and data handling Out of hours/leave cover Randomisation & un- blinding procedures End of trial & archiving procedures

17 Dos and Donts 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 gaps Be honest - we know we have some gaps and are addressing them - failure to recognize the gaps is more problematic than acknowledging the gaps Avoid being confrontational - esp. avoid giving the impression that this is bureaucratic detail Avoid being confrontational - esp. avoid giving the impression that this is bureaucratic detail Be alert to areas of improvement Be alert to areas of improvement Avoid being defensive. Avoid being defensive.

18 Dos and Donts during Interview Only answer the question asked Only answer the question asked If mistakes are made or wrong answers given, correct them at an appropriate time, or ensure somebody else does so. If 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 leave Try your best to correct any deficiencies noted by the inspectors before they leave Demonstrate confidence in your trial systems and data – you know it best. Demonstrate confidence in your trial systems and data – you know it best. Be positive.

19 Dos and Donts 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. 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. Dont volunteer information Dont volunteer information It is appropriate to challenge a finding made by an inspector if you are certain they are incorrect, but do not persist in your objection. It is appropriate to challenge a finding made by an inspector if you are certain they are incorrect, but do not persist in your objection.

20 What happens after the inspection? MHRA to report issues within 30 days of the inspection, summarising findings. MHRA to report issues within 30 days of the inspection, summarising findings. University response will include an action plan, timelines to address any 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. MHRA receive response - will issue a closing letter and GCP Inspection Statement. Future inspections will be performed at a frequency determined by the MHRA. Future inspections will be performed at a frequency determined by the MHRA. Possible routine GCP inspection of NHS Grampian Possible routine GCP inspection of NHS Grampian

21 Summary Review your trial documentation and training files for staff.Review your trial documentation and training files for staff. Have evidence of training (GCP certificate, CV)Have evidence of training (GCP certificate, CV) Ensure you can explain your role in the trialEnsure you can explain your role in the trial Review the typical questions and answers providedReview the typical questions and answers provided Familiarise yourself with new SOPs when availableFamiliarise yourself with new SOPs when available Be confident of your trial and processes. Remember that you know your trial better than anyone else.Be confident of your trial and processes. Remember that you know your trial better than anyone else.

22 Any Questions? Main Contacts: Prof Phil Hannaford – Prof Phil Hannaford – Prof Alison MacLeod – Prof Alison MacLeod – Dr Gail Holland – Dr Gail Holland – Tel: Tel: Lynda Sime – Lynda Sime – Tel: Tel:


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