Clinical Trials

Clinical trials play an essential role in the development of new medical products and are a required part of the research 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 involving human subjects that use investigational and/or marketed medicinal products and/or medical devices. The policy applies to all Baxter-sponsored studies worldwide.

The standards Baxter adheres to include, but are not limited to, the standards found in the following documents:

• 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 and administrative provision of the Member States relating to the implementation of good clinical practices in 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 written consent. 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 applicable country-specific requirements.

For any clinical trial that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome, the trial will be registered at www.clinicaltrials.gov within three weeks after the first subject has been recruited.