An Introduction to MHRA and GCP Inspections ndash; Lynne ...课件.PPT

The Process Baseline questionnaire Risk Factors Number nature of clinical trials Number of investigators (on/off site) Approximate number of trial subjects IMP PV Quality systems Establish database analyse data Identify organisations for inclusion in the schedule Roll-out MHRA Non-commercial Survey Next Steps Data Analysis Follow-up Identify ‘key players’ organisations potentially of high risk Follow-up sample of questionnaires non-responders Draft schedule to run in parallel, complimentary to current schedule Time-lines First questionnaires distributed December 2005 Queries coming in First questionnaire deadline mid February 2006 Database follow-up by end March 2006 Full schedule roll-out financial Q2 onwards Non-commercial Inspections How do we do them? Same regulatory framework reference standards Same inspection documentation Same inspection objectives Different scope to interview sessions – recognise one person wears ‘many hats’ Different funding sponsor arrangements Different trial approval processes Potential to combine sponsor/investigator inspections What will happen? (Routine Systems) Annual Plan produced; rolling programme of notification Advance notification - two to three months Pre-inspection dossier - ONE lever-arch file Contact name to manage the logistics Company details: size nature of activities, organisation charts List of trials (under the Directive) dating back about a year SOP index procedures in specific areas Inspector reviews dossier, contacts organisation with proposed dates, works with organisation on the plan Activities of Interest * Contract Management * Regulatory submissions * Project management * Quality Assurance * Monitoring * Training * Pharmacovigilance * Computer systems * Medical Advisors * Report writing * Data management * Archives * Statistical Analysis * Laboratories * Investigational medicinal product managemen