Societies Society of Clinical Research Associates (SoCRA) Society for Clinical Trials (SCT) American Society of Clinical Oncology (ASCO) Canadian Resources TCPS 2—2nd edition of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans ICH Integrated Addendum - Good Clinical Practice E6(R2) ICH Guidance E6 – Good Clinical Practice (ICH GCP) Food and Drug Regulations – Part C, Division 5 "Drugs for Clinical Trials Involving Human Subjects" Initiative to Streamline Clinical Trials Health Canada GCP Pre-Inspection Package - current as of March 2014 US Resources US Code of Federal Regulations, Title 45 Part 46 Office for Human Research Protections(OHRP)(United States) CTMB Audit Guidelines - March 2014 Summary of Changes to CTMB Audit Guidelines - March 2014