Implementation of Regulatory Aspects of Clinical Research is critical - 0 views
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Regulatory Aspects of research good clinical practice guidelines
shared by Roger Steven on 23 May 16
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Roger Steven on 23 May 16Implementation of Regulatory Aspects of Clinical Research is critical One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have spelt out a number of regulations that have to be complied with if the clinical research is to be approved. These regulatory requirements cover all aspects of clinical research. A look at some of these regulatory aspects would be instructive: FDA requirements on regulatory aspects of clinical research The FDA has an exhaustive list of regulations relating to Good Clinical Practice (GCP), the area which forms the backbone of regulatory aspects of clinical research. The FDA has a series of regulations that are aimed at bringing in discipline and process into clinical research. It implements all the laws relating to GCP passed by the American Congress. At present, there are a huge number of regulatory standards and requirements that have to be complied with by those undertaking clinical research in the US. These regulations are codified in the 21 CFR series. Notable sections of the 21 CFR series relating to regulatory aspects of clinical research include: 21 CFR Part 11 21 CFR Part 16 21 CFR Part 50 21 CFR Parts 50 and 56 21 CFR Part 54 21 CFR Part 58 21 CFR Part 312 21 CFR 312.120 21 CFR Part 314 21 CFR Part 320 21 CFR Part 511 21 CFR Part 514 21 CFR Part 601 21 CFR Part 812 21 CFR Part 814 EU requirements on regulatory aspects of clinical research In the EU, the core aspect of regulatory aspects of clinical research relates to the primary importance given to the subjects in a clinical research. For example, regulatory aspects of clinical research France are guided by the Public Health Code and Civil Code. This Code contains a list of regulatory conditions clinicians are obliged to adhere to. These regulations are to be monitored by a number of regulation enforcement bodies that the French governm