Glossary

Glossary
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  • Gene Therapy
    The treatment of genetic disease accomplished by altering the genetic structure of either somatic (nonreproductive) or germline (reproductive) cells.

    General Assurance
    Obsolete term, previously used to denote an institutional assurance covering multiple research projects. (See also: Assurance.)

    General Controls
    Certain FDA statutory provisions designed to control the safety of marketed drugs and devices. The general controls include provisions on adulteration, misbranding, banned devices, good manufacturing practices, notification and record keeping, and other sections of the Medical Device Amendments to the Food, Drug and Cosmetic Act [21 U.S. Code §360(c) (Food, Drug and Cosmetic Act §513)].

    Genetic Screening
    Tests to identify persons who have an inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders.

    Genotype
    The genetic constitution of an individual.

    Grant
    Financial support provided for research study designed and proposed by the principal investigator(s). The granting agency exercises no direct control over the conduct of approved research supported by a grant. (Compare: Contract.)

    Guardian
    An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care [45 CFR