Implementation 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.

regulatoryAspectsOfClinicalResearch

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 government has set up. These bodies both authorize and monitor regulatory aspects of clinical research in France. Irrespective of the kind of clinical research that is being carried out; principals and sponsors of clinical research need to be guided by this guiding principle that is enshrined in Article L. 1121-2 of the Public Health Code: "The interests of those who take part in biomedical research must always prevail over the interests of science and society."

regulatoryAspectsOfClinicalResearch

This dictum perhaps serves as some kind of indicator of the expectations France has of regulatory aspects of clinical research. While this example is that of France, no country in the EU has a policy on regulatory aspects of clinical research that are at wide variance from this.

Some landmarks in clinical and medical research in the EU

During the course of its journey, regulatory aspects of clinical research have been through a series of milestones. Each of these has been responsible for cultivating a culture of regulatory compliance in the EU. These declarations on the regulatory aspects of clinical research have served to be the guiding principles of clinical and medical research in the EU:

  • The Declaration of Helsinki of 1964
  • Code of Nuremberg of 2008
  • Declaration of Geneva of 2008
  • Amendment to the Declaration of Helsinki of 2008