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Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: 11 — electronic records and electronic signature related; 50 Protection of human subjects in clinical trials; 54 Financial disclosure by clinical investigators [2] 56 Institutional review boards that oversee clinical trials
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today ...
Regulatory agencies deal in the areas of administrative law, regulatory law, secondary legislation, and rulemaking (codifying and enforcing rules and regulations, and imposing supervision or oversight for the benefit of the public at large). The existence of independent regulatory agencies is justified by the complexity of certain regulatory ...
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
The clinical trial regulations (EU-CTR) ensure that the rights, safety, dignity and well-being of subjects are protected and data generated during clinical trials are robust and reliable. [2] The regulation aims to harmonize the processes for assessment and oversight of clinical trials throughout the EU.
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.