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 #3 Hosting the Audit

4. Agenda • AIPP Program • Session Objectives • Hosting the Audit • Arrival • Opening Meeting • Conduct • Document and Record Control • Document Duplication • Daily Review and Reporting • Questions and Answers

5. Objectives of the Session Increase research team’s comfort with hosting an audit Promote compliance Introduce audit related document management concepts

6. Arrival of the Auditors Auditors should arrive at time of posted office hours Check credentials now or at opening meeting Sign them in your guest book Put them into your board room – close the door Reasonable to offer coffee, tea or water Notify investigator, administration and staff that they have arrived

7. Opening Meeting Introductions • Host take the lead • Introduce yourself, staff and quests/contractors Take credentials (usually they will offer a card or their ID Number) Accept notice of audit (if applicable) Take minutes of the meeting

8. Opening Meeting Lead Auditor should: • Review the purpose, scope and audit schedule. • Review audit plan (role of audit team members, expected duration of audit, work schedule) • Note space requirements and adjust if necessary • Note time of expected exit interview If they don’t review the above – ask them to.

9. Opening Meeting Auditor may ask for the following: • Audit History • Site History • Organizational Chart (current and/or past) • Site map Meeting adjourned May ask for a site tour next

10. Recording in Audit Notebook All areas visited Whom they spoke to Questions and answers Comments Suggestions Any commitments you make (not recommended at this point) Unanswered questions Documents requested and provided

11. Recording in Audit Notebook Indelible ink Consecutive order with pages numbered x of y (by day) Signed and dated All corrections initialled and dated

12. Audit Conduct The Do’s: • Be cooperative • Be pleasant • Accompany auditor at all times • Answer questions in a concise and accurate manner

13. Audit Conduct More Do’s: • If you are uncertain about what is being asked do ask for clarification or request that the question be rewarded • If you do not know the answer to a question: • tell the auditor that you do not know the answer • ensure that the auditor is directed to someone that does know

14. Audit Conduct The Don’t(s): • Do not try to answer a question you do not know the answer to. • Do not comment on how you think the audit is going and do not compare it to the last one • Do not offer information that was not requested • Do not speak with an auditor outside of the organization during the audit period

15. Audit Conduct More Don’t(s): • Do not try to bribe an auditor • Do not make any changes to documents during an audit ( if you have you must let the auditor know).

16. Audit Conduct Confidential Statement of Fact: • Make a CSF in the presence of a witness prior to providing confidential information to an auditor • Examples of when this would arise: • Study data, listings of data and reports or charts that identify patients by their initials or the study by name or acronym, screening or registration documents • Contracts, financial statements, administrative documents, intellectual property

17. Audit Conduct Affidavit: • Can come up in investigations or for cause inspections - rare • Employee is asked to voluntarily produce and sign a statement or sign a prepared affidavit • Follow your institutional policy on this. Most recommend that you sign only after review by Management • Management may consult with Legal counsel

18. Document and Record Control for an Audit Keep track of documents and records requested by the auditor: • Note the name, version and class as applicable • Note when requested / provided • Note when returned • Copies retained (overnight or permanent) • Note when checked and re-filed • Note any damage

19. Document and Record Control for an Audit Recommend that all documents and records be verified as returned at the end of each audit day and before the exit meeting. At a small site the Host and the Audit Document Manager may be the same. Adjust according to volume of documents requested.

20. Document Duplication If an inspector asks for a copy of a document you make one, plus a duplicate. You will be making yourself a complete set of the same documents that the inspector may have taken as evidence for a finding. It is too hard to put it all together later from your originals - even if you took great notes. If an inspector takes a photograph of something, you take a photograph as well.

21. Demonstrations – Be Ready Maintain confidentiality of other studies Take your demonstration notes with you (see long term preparations) Have your computer demo site ready Make sure they sign-in and out of any secured areas that you have to take them to

22. Daily Review and Daily Reporting Some auditors have a daily review (meeting) • Host attends • Auditor notes daily findings • Auditor indicates what to expect for the next day Daily reporting - Internal • Host prepares a brief report for QA or Management • Host briefs the staff

23. Questions and Answers

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

25. 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

26. 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.