This is due by 1am Central Standard Time tonight, the latest! APA Style. Title Page not needed.
The International Congress on Harmonisation
The International Conference on Harmonisation (ICH) identifies four critical aspects of clinical research where standards are being determined for conducting clinical trials throughout the world. Quality, safety, and efficacy standards have been developed and are continually under review and revision. Topics that do not fit into any of these categories are referred to as multidisciplinary standards. Clinical research administrators must keep these standards at the forefront of their minds as they oversee clinical trials in their enterprises.
In this Application Assignment, you will explore the basic principles that underlie the current ethical standards in clinical research as outlined by the ICH. You'll find that much of the ICH guidance corresponds to current legislative requirements for clinical research in the United States.
To prepare for this Application Assignment:
Review the Learning Resources for this week.
Visit the International Conference on Harmonisation (ICH) Web site at [url removed, login to view] Go to the Guidelines and review the following.
o Quality topics
o Safety topics
o Efficacy topics
o Multidisciplinary topics
Reflect on the value the ICH Guidelines bring to the field of clinical research.
With this in mind, write a 3- to 4-page paper that analyzes why it is necessary to harmonize clinical research practices with the contribution of bodies such as the International Conference on Harmonisation.
References: [url removed, login to view]
I attached an example of an article you can use. But there are more on the website above.