BC Clinical Research Infrastructure Network

1. BC Clinical Research Infrastructure Network BCCRIN Changing the landscape for clinical research in BC. www.bccrin.ca

2. Lunch and Learn SeriesAudit and Inspection Preparedness Program

3. LL #2 Preparations Upon Notice of Audit

4. Agenda Introduction • AIPP Program • Session Objectives • Short Term Preparations • Questions and Answers

5. Objectives of the Session Increase research team’s comfort with preparing for and hosting an audit Promote compliance Introduce compliance management and quality management concepts

6. Confirmation of Notice Train your reception staff to know who they should put an auditor in touch with if one calls (the Host or Investigator). Confirm the audit date and make a note of it. You may be able to negotiate the date a little if it is a sponsor or a qualification audit as there is often three or four weeks notice. You will get one or two weeks notice for most other audits.

7. Confirmation of Notice When confirming an audit date, be bold and confident and ask for: • The purpose of the audit • The scope of the audit • The areas for review • An agenda If it is notice of a regulatory audit, the initial phone call may be your only chance to obtain any information about the audit, so ask then.

8. Designation of Audit Personnel Audit Host (aka Facilitator): • Calm, organized, articulate, the person that can lead your group through an audit • Regulatory Audit – Person should know the organization/site, systems and procedures well • Study related audit – Person familiar with the study, TMF/SMF and the systems & procedures that you have

9. Designation of Audit Personnel Role of the Audit Host: • Acts as contact at time of notice • Liaises with the auditor pre-audit as necessary • Attends the opening and exit meetings • Notes all document requests • Notes all topics and question areas • Ensures that all questions are answered • Conveys information to staff and administration at the end of each audit day

10. Designation of Other Audit Personnel Document Manager: • Controls documents during an audit Scribe (for Regulatory Audit or for cause audit): • Records all conversations, requests, topics of inquiry, unanswered questions • Accompanies Facilitator and Auditor • Also used for Exit Meetings

11. Designation of Audit Personnel QA or Compliance Specialist: • Consider the need (first audit, major qualification audit, regulatory audit, back to back audit, for cause audits, no notice, joint foreign inspection, investigation) Write down the Roles and outline of the duties.

12. Inform Inform those who need to know that there is an audit scheduled: • Management/Administration/Institution Rep • QA • Sponsor • REB/IRB • Medical Records/Off Site Storage Facility • IT Department/Security • Monitor

13. Team Meeting Host calls a meeting to get organized Inform staff about the purpose and scope of the audit Review your Audit Preparedness Plan Identify what still needs to be done based on the scope and purpose in the time available Assign someone to each task. Write out a checklist and ensure tasks are completed

14. Priorities Book Rooms Phone and photocopier Review the pertinent files (study) Review the TMF or SMF and Essential Documents Review your sample demonstration outlines and rehearse if necessary Prepare your controlled document listings and make sure they are up to date

15. Priorities Cont’ Reports – run them the day before if possible or alert the IT group that they may be needed Check that all training files are up to date • Signed at dated CV and qualification certificates • Signed job description (current and old) • Complete training records Retrain staff on audit conduct and audit procedures Practice with people likely to be interviewed

16. Priorities cont’ Check quality systems Check location of validation documentation and make sure it is in order (all binders accounted for) Check that controlled document binders/folders are all in order (current and obsolete SOPs etc) Check that the Audit Kit is up to date

17. Office preparation Do a walk through spot check of the general office • Clean up • Do filing File/Records room • Locked cabinets • Everything put away • Sign in/Sign out sheets in order • Label covers on file cabinets etc

18. Office Preparation Server room and IT - sponsors • Visit it • Check logs • Make sure control reports have been run • Check tape and backup items have been logged

19. Final Meeting Have a final meeting to ensure everything on your checklist is done Review greeting and sign in procedures Provide a space for the auditors to work Prepare a place for your Document Manager to work Remember, you have some control

20. Questions and Answers

21. Prepared for BCCRIN by: Jean SmartSmart QAS3375 West 26th AvenueVancouver, BCV6S 1N4Ph. 604-612-6372 email jesmart@telus.net

22. References Health Canada, Food and Drug Regulations, Part C, Division 5, Drugs for Clinical Trials Involving Human Subjects, (Schedule 1024), June 20, 2001. Health Canada, Guidance for Industry, Good Clinical Practice: Consolidated Guideline, ICH Topic E6, 1997. Health Canada, Health Products and Food Branch Inspectorate, Classification of Observations made in the Conduct of Inspections of Clinical Trials (GUIDE-0043), Revised Edition - August 29, 2008 Health Canada, Guidance Document - Annex 13 to the Current Edition of the Good Manufacturing Practices, Revised Edition - August 7, 2009 Health Canada, Guidance for Records Related to Clinical Trials (GUIDE-0068), Revised Edition - June 15, 2006 Health Canada, Health Products and Food Branch Inspectorate, Inspection Strategy for Clinical Trials, January, 2002 Health Canada, Health Products and Food Branch Inspectorate, Compliance and Enforcement Policy. No. POL-0001, May 30, 2005

23. References International Organization for Standardization (ISO), 9001:2008 - Quality Management Systems Requirements, ISO, 4th Edition, November 15, 2008, pgs 36. (replaced ISO 9001:2000) Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, Annex 11, Computerised Systems, Edition September 25, 2007. US Food and Drug Administration, Compliance Program Guidance Manual, Program 7348.810, chapter 48, Edition: March 11, 2011 Office of Inspector General, Compliance Program Guidance. April 2003. Federal Register, Vol 68. No. 86 May 5 2003 Notices. European Forum for Good Clinical Practice - Audit Working Party, Revision of the Engage Auditing Guideline: An Optimal Guideline for GCP Compliance and Quality Management Systems Auditing, Engage publication, 2005. FDA Enforcement Statistics Summary Report 2008, Chapter 11. (Stats for 2004 to 2008). Jepson, Gordon. Consequences of Non Compliance in Canada. Regulatory Focus. January 2007.Vol 12 No.1 p 14-17.