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class of research trial

ICH-GCP is a commonly used abbreviation for the ICH Harmonised Tripartite Guideline on Good Clinical Practice E6

The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the USA to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

An inspection is conducted by a regulatory authority(ies) whereas an audit is conducted by the sponsor's auditor.

According to ICH-GCP, an inspection is an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial (under scrutiny) and that may be located at the site of the trial, at the sponsor's and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies) - see ICH GCP §1.29.

An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB) is a

Under FDA regulations "research" is synonomous with the term "clinical investigation" and means any of the following:

There are four levels of biosafety used to designate and regulate lab work with microorganisms. The range is BSL-1 in which the microorganisms are not known to cause disease in healthy adult human beings to BSL-4 in which the microorganisms pose a risk of life-threatening disease and for which there is no known  vaccine or therapy. BSL-3Ag refers to research involving large agricultural animals. There are guidelines in place to ensure safe work sites through a combination of engineering controls, management policies, work practices, and procedures. Increasing levels of personnel and environmental protection are provided for by the different biosafety levels used in microbiological/biomedical laboratories. The higher the level of the biosafety lab, the more stringent the level of protection. (Source: U.S. Department of Homeland Security).