Good Clinical Practice and the ICH

GCP Laws The author of this report shall be comparing and contrasting the differences in laws relating to global clinical practice (GCP) around the world in addition to any regulations, guidance and standard operation procedures (SOP's) that relate to the same. Finally, there will be an explanation of how they all reflect the influence of the ICH's Guideline for Good Clinical Practice E6.

While different countries and cultures tend to do things a bit differently, the overall international guidelines of good clinical practice are usually reflected regardless of where one goes and what culture or country one is talking about. One agency that is certainly focused and centered on good clinical practice would be the Food and Drug Administration (FDA) in the United States.

One example of the Food and Drug Administration's adherence to good clinical practice is that they will update their rules and regulations to reflect any changes in the laws that are enacted or changed by the United States Congress. There is also a publication issued with each change that explains what the change was, why the change was made, how the change was or will be made and so forth.

The preamble of any such publication will include an environmental impact assessment, an analysis of the cost impact, comments on the Paperwork Reduction Act and the overall effective date of the implementation (or revocation of the rules that are changing (FDA, 2015). The aforementioned statement applied mostly to clinical trials. Much the same due diligence occurs in the United Kingdom (UK) when changes are made, for example.

As stated on the UK government website, there is a similar change on the other side of the pond when it comes to changes that affect anything that includes pharmaceutical companies, contract research organizations, universities, National Health Service (NHS) hospitals, charities, GP practices and clinical laboratories and their iteration of good laboratory practice. Indeed, the United Kingdom has their own version of the FDA that is known as the Medicines and Healthcare products Regulatory Agency, or MHRA for short.

To ensure good clinical practice, they engage in behaviors such as asking trial sites to notify them of serious breaches, carry out inspections of trial sites when breaches are reported, carry out general inspections of clinical trial sites and carrying out of inspections on sites when companies apply for authorization for marketing authorizations (GOV.UK, 2015).

As far as how all of this dovetails with the ICH and how they regulate and give guidance about the situation, the UK and the United States are both obviously complying with the general guidelines offered by the ICH. These guidelines include a description of the responsibilities and expectations that should be held against those ostensibly engaging in good clinical practice, the role of the investigators, the role of those who monitor good clinical practice and the IRB's in general (ICH, 2015).

Conclusion The good clinical practice guidelines as explained by the ICH specifically cover the monitoring.