Bernard Lo and Nesrin GaranScott Kurtzman and Zita LazzariniJeffrey S. Abrams and Anthony Murgo and Michaele C. ChristianSteven HirschfeldAnn M. Mauer and Elizabeth S. Rich and Richard L. SchilskyBarbara ParkerFran ViscoStanley P. L. LeongY. Nancy You and Lisa Jacobs and Elizabeth Martinez and David M. OtaJohn M. Harrelson and John M. FallettaE. Greer GayGerianne J. Sands and Peggy A. MeansPeter Abbrecht and Nancy Davidian and Samuel Merrill and Alan R. PriceLeonard A. Zwelling and Carleen A. BrunelliGreg KoskiStanley P.L. Leong and Larry Carbone and Scott Kurtzman

Contributors	p. vii
Foreword	p. xiii
Preface	p. xvii
Acknowledgement	p. xii
1 Historical Perspective and Evolving Concerns for Human Research	p. 1
2 Cancer Trials and the Institutional Review Board (IRB)	p. 11
3 NCI's Cancer Therapy Evaluation Program: A Commitment to Treatment Trials	p. 31
4 Practical Guide for Cancer Clinical Investigators	p. 51
5 The Role of Cooperative Groups in Cancer Clinical Trials	p. 111
6 The Advocate Role in Clinical Study Development and Partnering with Patient Advocates in Your Local Institution	p. 131
7 The National Breast Cancer Coalition: Setting the Standard for Advocate Collaboration in Clinical Trials	p. 143
8 The Role of the Principal Investigator in Cancer Clinical Trials	p. 157
9 The Audit Process and How to Ensure a Successful Audit	p. 179
10 The Privacy Rule (HIPAA) As It Relates To Clinical Research	p. 199
11 The Commission on Cancer, American College of Surgeons' Response to HIPAA	p. 209
12 Ethical and Legal Issues in the Conduct of Cancer Clinical Trials	p. 219
13 The Role of the Office of Research Integrity in Cancer Clinical Trials	p. 231
14 Strategies for the Administration of a Clinical Trial Infrastructure: Lessons from a Comprehensive Cancer Center	p. 241
15 The Clinical Research Process: Building a System in Harmony with Its Users	p. 275
16 Cancer Research and Clinical Trial in Action: An Important Exercise Before You Embark on Your Study	p. 291
Index	p. 311