ACRIN AUDIT Manual v 8 rev 100102

AUDIT MANUAL ACRIN AUDIT MANUAL Prepared by the American College of Radiology Imaging Network Protocol Development and Regulatory Compliance Department Original: October 2001 Revised: June 2010 American College of Radiology Imaging Network Mitchell D. Schnall, MD, PhD 1818 Market Street, Suite 1600 Network Chair Philadelphia, PA 19103 University of Pennsylvania Health SystemPhone: 1-800-227-5463 / 1-215-574-3150 Department of Radiology 3400 Spruce Street Philadelphia, PA 19104 JUNE 2010 PAGE 2 of 37 ACRIN AUDIT MANUAL Table of Contents Preface .………………………………….…………………………………….……… 5 What Is the Purpose of The Audit Manual? ……………………..……..……… 5 Are Non-NCI-Funded Trials Audited Differently Than NCI-Funded Trials? … 5 What Should I Know About Using This Manual? … .……………..................... 5 Chapter 1 – Introduction to ACRIN and the NCI ………………………………… 6 What Is ACRIN? …..…………………………………………………………... 6 What Types of Imaging Studies Does ACRIN Conduct? ……………………… 6 What Are ACRIN’s Research Objectives? ….…………….……….................... 6 What Is the NCI? …………..……………………………….………………….. 7 What Is the DCTD? …………………………..……………….……………….. 8 What Is CIP? ..………………………………….……………….…………….... 8 What Is CTEP? .………………………………………………….…….………. 8 What Is CTMB? .……………………………………………………………….. 9 Chapter 2 – Introduction to the Audit Program ...