Product Responsibility - Baxter Sustainability Report

Clinical TrialsClinical trials play an essential role in the development of new medical products and are a required part of theresearch process for many Baxter products. Baxter protects the safety and privacy of clinical trial participants,as well as the integrity of data obtained from these studies.Baxter's Clinical Trials Policy defines the requirements for clinical trials, studies and investigations involvinghuman subjects that use investigational and/or marketed medicinal products and/or medical devices. Thepolicy applies to all Baxter-sponsored studies worldwide.The standards Baxter adheres to include, but are not limited to, the standards found in the followingdocuments:• Guidelines for Good Clinical Practice (GCP), edited by the International Conference on Harmonization (ICH),Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP);• Declaration of Helsinki and the laws and regulations of the applicable country;• International Ethical Guidelines for Biomedical Research Involving Human Subjects;• Directive 2001/20/EC and Directive 2005/28/EC on the approximation of the laws, regulations andadministrative provision of the Member States relating to the implementation of good clinical practicesin the conduct of clinical trials on medicinal products for humans for Europe; and• Applicable privacy and data protection standards.Clinical trials require prior written approval by an Independent Ethics Committee/Institutional Review Board.Prior to any study-related activities or assessments, the study subjects must provide informed writtenconsent. All studies must comply with applicable privacy laws and regulations including, but not limited to,the U.S. Health Insurance Portability and Accountability Act regulations or other applicablecountry-specific requirements.For any clinical trial that prospectively assigns human subjects to intervention and comparison groups tostudy the cause-and-effect relationship between a medical intervention and a health outcome, the trial willbe registered at www.clinicaltrials.gov within three weeks after the first subject has been recruited.http://www.sustainability.baxter.com/product-responsibility/research-development-design/clinical-trials.html© Copyright 2011 Baxter International Inc. All Rights Reserved.