1. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 REVISED AUDIT MANUAL Chris Steward, ACRIN Quality Control Auditor

2. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 Audit Team  Mary Kelly-Truran, Quality Control Auditor  Nicole Spiese, QC Auditor / Regulatory Specialist  Chris Steward, Quality Control Auditor

3. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 Audit Program  Audits are conducted per the ACRIN Audit Manual  Become familiar with the Audit Manual  Audit Team is always available to answer questions – contact information on ACRIN website

4. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 Why do we audit?  Participant Safety  Data Integrity  Regulatory Compliance  Education

5. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 What do we look at?  Regulatory Documents  Participant charts  Informed Consent  Eligibility  Protocol compliance  GCP Compliance (ICH E6)

6. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 TOP 7 LIST TIPS FOR A SUCCESSFUL AUDIT 1.Audit prep starts when you first decide to participate in a trial 2.Know the protocol 3.Do what it says 4.Know your GCPs 5.Communicate with ACRIN a.Participate in conference calls b.Refer any questions to appropriate ACRIN personnel – e.g., Project Manager, Data Manager, Monitor, Auditor, Imaging Specialists, etc… 6.Document everything – “If it’s not documented, it didn’t happen” 7.Get to know your IRB and their requirements

7. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 ACRIN Audit Manual  New Audit Manual – revised as follows:  Updated to reflect current procedures  Designed for use by study site personnel  Removed extraneous material  Accessed from the ACRIN website  Still under revision – but may be used in draft form

8. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 ACRIN Home Page

9. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 Administration

10. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 Regulatory Resources

11. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 ACRIN Audit Manual

12. Revised Audit Manual – Fall Meeting 2009 September 30, 2009 Thank-you