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A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research.
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 Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice. This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.
Nigeria charged 76 people, including 30 minors, with treason and inciting a military coup after they took part in deadly August protests against economic hardship, court documents showed on Friday.
The right to withdraw is a concept in clinical research ethics that a study participant in a clinical trial has a right to end participation in that trial at will. According to ICH GCP guidelines, a person can withdraw from the research at any point in time and the participant is not required to reveal the reason for discontinuation.
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