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Research Governance Non-commercial Clinical Trials

Research Governance Non-commercial Clinical Trials. The Inspectors are coming. MHRA GCP Inspection. Background: The Clinical Trial Directive 2001/20/EC Medicines for Human Use Act (CT) 2004 Mandates regulatory GCP and GMP inspections to cover Investigator sites Manufacturing sites

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Research Governance Non-commercial Clinical Trials

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  1. Research Governance Non-commercial Clinical Trials The Inspectors are coming

  2. MHRA GCP Inspection • Background: • The Clinical Trial Directive 2001/20/EC • Medicines for Human Use Act (CT) 2004 • Mandates regulatory GCP and GMP inspections to cover • Investigator sites • Manufacturing sites • Laboratory • Sponsor premises

  3. MHRA Approach • Overall aim is to establish whether a Sponsor has adequate Quality systems in place that are: • Effective • Adequately resourced • Complied with • Continually improved

  4. MHRA Approach • Documentation, consent, site file, notes,delegation records, training records etc. • Site monitoring and study conduct to GCP standards • Key management and approval processes • Relevant SOP’s and logs • Evidence of process compliance audit and monitoring • IT support

  5. MHRA Approach • Activities that be inspected • Project management / Reporting • Protocol adherence / appropriate delegation (log) • Training (evidenced) • Documentation / Archiving • Site conduct to regulatory standards • Pharmacovigilance. SAE reporting & action • Monitoring and audit

  6. Inspection conduct • Tours of the facility: • R&D and R&D Support • Research facility and offices • Pharmacy • IT • Radiology • Laboratories • Records

  7. Inspection Conduct • Notification of inspection • Provide dossier identifying non-commercial clinical trial activity within the Trust • Receive inspection plan • Introductory meeting • Staff interviews: looking into giving 6 weeks notice to cancel clinics. All staff must attend when asked

  8. After the Inspection • Urgent action will be notified immediately • Initial report • Responses to non-compliance • Final report: finding grades • Critical • Major • Minor

  9. Enforcing the Regulations in the UK • Infringement notice • Potential re-inspection • Specifies corrective / preventative measures needed • Warning for non-compliance of corrective measures • Relevant Regulatory bodies notified

  10. UK Criminal offences • Start or conduct of any clinical trial activities without Ethics Committee Approval and Competent Authority Authorisation [MHRA] • Failure to notify the end of a Clinical Trial • Urgent safety measures not implemented • “A person does not commit an offence under these regulations if he or she took reasonable precautions and exercised all due diligence to avoid the commission of that offence”

  11. What about Non-Clinical Trial Research Activity • Regulatory requirement for the Trust (R&D) to monitor 10% of all non-commercial clinical trials yearly • Monitor to the MHRA / Industry “gold standard” • Good practice to monitor other research ‘areas’ as part of quality assurance, risk management • Monitor and audit compliance of management & approval procedures • Highlight risks of non-compliance • Risk register part of the corporate risk reporting

  12. What are we doing • Dissemination of information, re-designing the web-site • EPR database update • Business Manager: grants • Clinical Trial Unit & Agreements • Exploring ways to comply with monitoring & audit: external sources, cross Trust monitoring • Bidding for extra resource to staff R&D

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