revised audit manual – fall meeting 2009 september 30, 2009 revised audit manual chris steward,...
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Revised Audit Manual – Fall Meeting 2009 September 30, 2009
REVISED AUDIT MANUAL
Chris Steward, ACRIN Quality Control Auditor
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
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
Revised Audit Manual – Fall Meeting 2009 September 30, 2009
Why do we audit?
Participant Safety
Data Integrity
Regulatory Compliance
Education
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)
Revised Audit Manual – Fall Meeting 2009 September 30, 2009
TOP 7 LIST
TIPS FOR A SUCCESSFUL AUDIT1. 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
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 websiteStill under revision – but may be used in
draft form
Revised Audit Manual – Fall Meeting 2009 September 30, 2009
ACRIN Home Page
Revised Audit Manual – Fall Meeting 2009 September 30, 2009
Administration
Revised Audit Manual – Fall Meeting 2009 September 30, 2009
Regulatory Resources
Revised Audit Manual – Fall Meeting 2009 September 30, 2009
ACRIN Audit Manual
Revised Audit Manual – Fall Meeting 2009 September 30, 2009
Thank-you