Clinical Drug Trial Investigator Key Terms

CSI without the dead bodies (hopefully)

Clinical drug trial investigator key terms include a few acronyms. These acronyms are used by nearly everyone in the field, so they're important to know. Clinical investigators register with the FDA for each clinical trial they are involved in and need to be up-to-date at all times with both U.S. and European drug regulations and standards, as well as standards of other organizations. Clinical drug trial investigators generally work for pharmaceutical companies.

 

ICH, GLP, international pharmaceutical regulations

Acronyms abound in highly technical jobs, and you don't often find these two spelled out because their real names are too long. ICH stands for International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. This is a U.S., Japanese and European body devoted to the safety of drug use for humans. GLP stands for Good Laboratory Practice. When people say "international pharmaceutical regulations," they are referring to the standards of these two organizations.
Try: The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) puts out papers on its findings for industry and investigator use. The GLP is not a static set of regulations; regulations are added, upgraded and/or changed for improvement.

Clinical drug trial or drug trial

Clinical drug trials are a very important part of developing medicine and drugs. A drug trial is a very serious enterprise requiring excellent physician skills and research methods. There are four phases to a drug trial as stipulated by the FDA.
Try: A drug trial is defined very simply here. ClinicalTrials.gov provides a deeper definition and description for the term.

GCP certificate

A "good clinical practice" (GCP) certificate is the certification that investigators take and pass after a course is taken on current good clinical practices.
Try: The University of Washington, Medicine provides a description and definition of good clinical practice.

FDA

The U.S. Food and Drug Administration is responsible for the health and well-being of its citizens in terms of food and drug safety. Clinical drug trial investigators have to follow these regulations.
Try: The FDA has the final say on legalizing a drug for consumer use. It ultimately makes a decision on a drug's safety at least partly through the clinical drug trial research and findings.

Pharmaceuticals

Pharmaceuticals are medicinal drugs. Drug trials are pharmaceutical trials.
Try: The Health Care Institute of New Jersey gives the history of pharmaceuticals. Pfizer is one of the world's pharmaceutical giants; you rarely hear any pharmaceutical company described as a "drug company," but Pfizer relies on clinical drug trial investigators.

Clinical investigator forms

Clinical investigator forms are the forms required from a clinical investigator by the FDA. These forms enforce objectivity on the part of the investigator, including requiring financial transparency on the payment from drug manufacturers.
Try: There are approximately 14 clinical investigator forms that need to be filed with the FDA.

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