The need to protect human subjects who participate in clinical research is universally recognized as reflected by the wide use of what is known as the Good Clinical Practice guidelines or principles. Many countries have adopted GCP guidelines and regulations, which consist of internationally accepted standards for the design, conduct, monitoring, and reporting of clinical trials.
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In the United States, the Food and Drug Administration (FDA) enforces a number of GCP guidelines and regulations pertaining to clinical trials. In addition, the agency has adopted the International Conference on Harmonization (ICH) E6 GCP Consolidated Guidance. These Good Clinical Practice guidelines and regulations apply to all clinical trials that fall under the FDA’s jurisdiction.
A good example of how GCP guidelines and regulations protect patients is the concept of “informed consent.” Under the FDA’s 21 CFR Part 50, informed consent helps ensure that subjects participate in a clinical trial voluntarily. The clinical investigator conducting the clinical trial is responsible for making sure that each participant is properly informed about the goals and corresponding risks of the study. The FDA requires subjects (or the subject’s authorized representative) to sign informed consent forms.
Medical device companies that sell their products in the United States must comply with the FDA’s GCP guidelines and regulations. In addition, most of them also comply with ISO 14155: 2011 (Clinical Investigations of Medical Devices for Human Subjects: Good Clinical Practices). Medical device firms that do business outside of the U.S. are also likely to adhere to the ISO Good Clinical Practice guidelines.
The GCP guidelines under ISO 14155: 2011 apply to the design, conduct, recording and reporting of clinical investigations conducted to assess the safety or performance of medical devices. It covers the responsibilities of sponsors and clinical investigators and makes recommendations on investigational plans, final reports, and assessments of adverse events.
The MasterControl Clinical Suite™ is a complete clinical quality management solution designed to help ensure compliance with Good Clinical Practice guidelines and regulations. The solution provides a single, web-based location for all critical documents and streamlines processes by managing all documents, tasks, processes, training, and audits throughout the life of a clinical trial. Here are some of benefits it provides:
For more information about GCP guidelines, and how MasterControl can help your organization achieve and sustain GCP compliance according to the FDA's rulings on GCP guidelines, please feel free to contact a MasterControl representative.