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Research Policy & Management RACD Medicines and Healthcare products Regulatory Agency (MHRA) Statutory Good Clinical Practice (GCP) Inspection of Cardiff.

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Presentation on theme: "Research Policy & Management RACD Medicines and Healthcare products Regulatory Agency (MHRA) Statutory Good Clinical Practice (GCP) Inspection of Cardiff."— Presentation transcript:

1 Research Policy & Management RACD Medicines and Healthcare products Regulatory Agency (MHRA) Statutory Good Clinical Practice (GCP) Inspection of Cardiff University

2 Research Policy & Management RACD The inspectors Inspection process Inspection Outcomes Preparing for the Inspection Experience of an inspection The plan for today

3 Research Policy & Management RACD The Inspectors Group Manager Inspections GMP Inspectors GCP Inspectors GLP Inspectors GPvP Inspectors Expert Inspectors Offices: York Welwyn Garden City Market Towers Serious Breach of GCP

4 Research Policy & Management RACD What does an inspection involve? http://www.mhra.gov.uk/CON2024532

5 Research Policy & Management RACD Pre-Inspection Dossier 1.Complete list of Clinical Trials (from May 2005) 2.Organisational charts 3.Overview of all facilities 4.Description of archiving arrangements 5.SOP index 6.Detailed procedures in relation to: 1.Trial management 2.Quality control and assurance 3.Computerised systems 4.Equipment maintenance 5.Supply of Investigation Medicinal Product 6.Laboratory procedures 7.Activities carried out by CU or contracted out by CU

6 Research Policy & Management RACD Clinical Trial Activities Archiving Contracts Project Management Computer Systems SOPs Data Management Training Regulatory approvals Statistics Drug Management Laboratory Study Monitoring Adverse Event reporting Trial reporting Randomisation Trial Files Any activity involved in the running of Clinical trials at our institution

7 Research Policy & Management RACD What happens during the visit? 1 week inspection by at least 2 GCP Inspectors Documentation review –University/School/Unit SOPs Facility Visits Inspection of several clinical trials to test systems Interviews with key personnel, e.g. –Chief / Principal Investigator –Research teams e.g. Research Fellow, Research Nurse –RACD –Laboratories –IT –Archiving facilities Inspection plan can change

8 Research Policy & Management RACD 3 categories of findings: Critical: –evidence that i) the safety, well-being or confidentiality of trial subjects have been or have potential to be jeopardised, ii) the clinical trial data are unreliable iii) there are a number of Major non-compliances, indicating a systematic quality assurance failure. –insufficient or untimely corrective action regarding previously reported Major non-compliances Major: –significant and unjustified departure from legislative requirements that may develop into a critical issue unless addressed, –a number of departures from legislative requirements and/or established GCP guidelines, indicating a systematic quality assurance failure. Other: –departure from legislative requirements and/or established GCP guidelines, but it is neither Critical nor Major. Inspection outcomes

9 Research Policy & Management RACD Organisation must respond within 30 days Critical Findings or a number of Major Findings may lead to suspension of one or all CTIMPs in the organisation Organisation response –Analysis of findings –Corrective Action –Preventative Action –Plans of assessing effectiveness of preventative action –Timelines –Disputed findings Response to Findings

10 Research Policy & Management RACD Contract & Agreement Preparation –Lack of written agreements with collaborators –Inconsistencies between protocol and contract –Delegation of duties without agreements/systems in place –Lack of identification of CI and all trial team at outset Quality System –Lack of SOPs –Insufficient time between issuing and implementing SOPs, leading to training issues –Team meetings not documented Training –Inadequate knowledge of Clinical Trial Regulations –Lack of GCP training amongst trial team Informed Consent –No record of consent –Incorrect version Common Findings

11 Research Policy & Management RACD Investigational Medicinal Product (IMP) management –Inadequate provisions for storage of IMPs –Insufficient records for the chain of custody –Inadequate procedures for QP release –Lack of documentation confirming role of Pharmacy/CI Pharmacovigilance –Inadequate Pharmacovigilance systems and/or inadequate use of systems in place –Lack of awareness of legislative requirements –Standardisation or arrangements for un-blinding SAEs arising from blinded trials –Annual safety report to MHRA not made Data management –Security of trial documents/data –Inadequate retention period –Lack of clarity of data entry and data query processes (Source Data Verification) Common Findings

12 Research Policy & Management RACD Information Management –Lack of assurance that systems are fit for purpose –Lack of evidence of system security –No clarity on arrangements for backing up data Regulatory Affairs (e. g. Clinical Trial Authorisations) –Remarks on MHRA approval letters not followed up –Unclear indemnity arrangements –Unclear sponsorship arrangements for DDX studies –Annual and end of study reports not sent Filing of essential documents –Poorly maintained site files –Poor document control and management –Forms not signed or not completed correctly Laboratory –No evidence of how equipment is maintained, calibrated and serviced Common Findings

13 Research Policy & Management RACD University (RACD) Preparations Pre-Inspection Dossier Awareness Raising Delegation of duties Review of Clinical Trial list Clinical Trial Monitoring Visits - essential documentation MHRA Inspection working group Risk Assessment/GAP analysis – based on common findings from previous MHRA inspections Individualised preparation plans

14 Research Policy & Management RACD Awareness raising Familiarity with legislation, internal and external guidance –ICH GCP (Topic E6) http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf –University Research Governance web page http://www.cf.ac.uk/racdv/resgov/index.html http://www.cf.ac.uk/racdv/resgov/index.html –www.ct-toolkit.ac.ukwww.ct-toolkit.ac.uk GAP analysis –Essential documentation / Unit SOPs –Action plan How can Research Groups/Units prepare?

15 Research Policy & Management RACD Familiarity with legislation, internal and external guidance –ICH GCP (Topic E6) http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf –University Research Governance web page http://www.cf.ac.uk/racdv/resgov/index.html http://www.cf.ac.uk/racdv/resgov/index.html –www.ct-toolkit.ac.ukwww.ct-toolkit.ac.uk Essential Documentation - Self-assessment of the trial using Trial Master File checklist –Approvals –Document Control –IMP management –Delegation Logs –SOPs –Pharmacovigilance –Equipment How can Researchers prepare?

16 Research Policy & Management RACD Summary Anyone involved in Clinical Trials Co-operation and engagement Early Preparation Action plan to remedy issues

17 Research Policy & Management RACD Contacts Research Governance Team resgov@cardiff.ac.uk X79277 (01798 79277 from Heath) Chris Shaw Matthew Harris Kathy Pittard Davies

18 Research Policy & Management RACD Medicines and Healthcare products Regulatory Agency (MHRA) Statutory Good Clinical Practice (GCP) Inspection of Cardiff University


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