Clinical Trial Guidebook

Clinical trials must be managed in an organized way where data can be verified for accuracy. Federal agencies such as the United States Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) have issued guidance to assist researchers. Although compliance with federal guidance is not required by federal agencies, guidance is usually an agency’s interpretation of the best way to meet the regulations. Good Clinical Practice (GCP) is an international quality standard that is provided by the International Conference on Harmonization (ICH). The ICH brings together regulatory authorities and pharmaceutical industries from around the world to discuss scientific and technical aspects of drug registration and approval. While some countries have adopted GCP as regulation, the FDA has adopted it as guidance. Emory has not formally adopted all organizational components of GCP; however, GCP is much of an Industry standard and some pharmaceutical or device companies require compliance with GCP in clinical trials conducted at Emory. Sponsors may require GCP standards as outlined in the clinical trial agreement, clinical protocol, or other written sponsor materials. The FDA GCP guidance incorporates the best practices for meeting the requirements of the federal regulations and will help the Investigator optimize compliance with the regulations. The purpose of this Clinical Trials Guidebook is to pull together some of the requirements of federal regulations, federal guidance, state and local laws, and Emory policies and translate them into practical instructions that are applicable to clinical trials at Emory.