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REVISED AUDIT MANUAL Chris Steward, ACRIN Quality Control Auditor

REVISED AUDIT MANUAL Chris Steward, ACRIN Quality Control Auditor. Mary Kelly-Truran , Quality Control Auditor Nicole Spiese, QC Auditor / Regulatory Specialist Chris Steward , Quality Control Auditor. Audit Team. Audits are conducted per the ACRIN Audit Manual

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REVISED AUDIT MANUAL Chris Steward, ACRIN Quality Control Auditor

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  1. REVISED AUDIT MANUALChris Steward, ACRIN Quality Control Auditor

  2. Mary Kelly-Truran, Quality Control Auditor Nicole Spiese, QC Auditor / Regulatory Specialist Chris Steward, Quality Control Auditor Audit Team

  3. 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 Audit Program

  4. Participant Safety Data Integrity Regulatory Compliance Education Why do we audit?

  5. Regulatory Documents Participant charts Informed Consent Eligibility Protocol compliance GCP Compliance (ICH E6) What do we look at?

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

  7. 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 ACRIN Audit Manual

  8. ACRIN Home Page

  9. Administration

  10. Regulatory Resources

  11. ACRIN Audit Manual

  12. Thank-you

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