Medical Research And Good Clinical Practices

By Berta Simon


Good clinical practices standards are the brainchild of the International Conference on Harmonization (ICH). This body was established for the purposes of protecting human beings who are used for medical testing. Other functions of the ICH, include regulating and setting standards for various governments around the world. This protects people when they are involved in medicine and medical equipment testing.

The regulations ensure that medicines are safe and efficient for human consumption. Guidelines are put in place to regulate the roles of participating parties such as monitors, researchers and sponsors. Monitors are also called research associates.

Courses are available for people who wish to study GCP. These courses are approved by the Medicines Control Council and certain Ethics Committees. Monitors and researchers are expected to sit in on the courses before being eligible to conduct research. Local forums accredit the courses before people can attend them.

Refresher courses are available to those individuals who have attended the basic courses. They will generally receive a certificate of attendance and in some cases be required to write a test. In most cases certificates are valid for 3 years.

Researchers have access to help desks that are situated in countries all over the world. Researchers use these help desks to improve the quality of the research. The information helps the researchers to keep within the recommended guidelines. Researchers can also access a website that contains information that has been offered by experts in the field.

Forums are available that permit monitors and researchers to communicate with each other regarding the testing of human beings. They can also see live examples of research in action. Good clinical practices are monitored by these forums. Formal procedures are laid out for any complaints, and it is important that researchers follow the guidelines that in place to lodge complaints. good clinical practices




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