News and Publications

Publications

International Compilation of Human Research Standards, Office for Human Research Protections; U.S. Department of Health and Human Services; 2018 Edition

U.S. Food and Drug Administration Compliance Program Guidance Manual. Program 7348.810. Chapter 48 – Bioresearch Monitoring: Sponsors, Contract Research Organizations and Monitors; April 2017

ICH E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1), Guidance for Industry; FDA; March 2018

U.S. Food and Drug Administration Compliance Program Guidance Manual. Program 7348.811. Chapter 48 – Bioresearch Monitoring: Clinical Investigators and Sponsor-Investigators; December 2008

Guidance for Industry: ICH Q9 Quality Risk Management; FDA; June 2006

U.S. Food and Drug Administration Office of Scientific Investigations and Office of Study Integrity and Surveillance; BIMO Metrics; December 2017

Guidance for Industry: ICH Q10 Pharmaceutical Quality System; FDA; April 2009

European Medicines Agency: ICH Guideline E17 on General Principles for Planning and Design of Multi-Regional Clinical Trials (Step 5); June 2018

Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety and Welfare of Study Subjects; FDA; October 2009

European Medicines Agency: Guideline for the Notification of Serious Breaches of Regulation (EU) No. 536/2014 or the Clinical Trial Protocol; January 2017

Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring; FDA; August 2013

News/Upcoming Conferences

To be Updated for 2019