Regulations

There are many regulations in the field of clinical research.  Before physicians begin any research, they should thoroughly understand these rules to ensure that their studies are conducted in conducted in compliance.  

Physicians and researchers conducting research in the United States should be familiar with the following parts of the Code of Federal Regulations (CFR) Title 21, defined by the U.S. Food and Drug Administration:

Good Clinical Practice (GCP)

Those who conduct clinical research should also be familiar with Good Clinical Practice (GCP).  

GCP refers to the principles and processes investigators are expected to comply with throughout their trials to ensure that the rights, well-being, and confidentiality of study participants are protected.  

GCP also ensures the collection of reliable data.