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Good Clinical Practice

Generalizable Knowledge

Information from which one may infer a general conclusion; knowledge brought into general use or that can be applied to a wider or different range of circumstances. For example, publication and presentation are typical methods used to disseminate research findings, thereby contributing to “generalizable knowledge.” However, not all information that is published or presented represents generalizable knowledge. Generalizable knowledge is also interpreted to include data intended for general use, regardless of its eventual distribution or acceptance.

Genetic Information Nondiscrimination Act (GINA)

GINA is a federal law that protects Americans from being treated unfairly because of differences in their DNA that may affect their health. The new law prevents discrimination from health insurers and employers.

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.


All the genetic material in the chromosomes of a particular organism; its size is generally given as its total number of base pairs.

Genome-Wide Association Studies (GWAS)

A GWAS is an approach that involves rapidly scanning markers across the complete sets of DNA, or genomes, of many people to find genetic variations associated with a particular disease. Once new genetic associations are identified, researchers can use the information to develop better strategies to detect, treat and prevent the disease. Such studies are particularly useful in finding genetic variations that contribute to common, complex diseases, such as asthma, cancer, diabetes, heart disease and mental illnesses.


The genetic constitution of an individual.


 Genetic Information Nondiscrimination Act of 2008


Good Manufacturing Practice

Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

Good Laboratory Practice (GLP)

GLP Standard compliance monitoring program ensures the quality and integrity of test data submitted in support of product registration.

Group C Treatment IND

"Group C" Treatment IND was established by agreement between the FDA and the National Cancer Institute (NCI). The Group C program is a means by which oncologists can use investigational drugs for the treatment of cancer under protocols outside the controlled clinical trial. Group C drugs are generally Phase III study drugs that have shown evidence of relative and reproducible efficacy in a specific tumor type. They can generally be administered by properly trained physicians without the need for specialized supportive care facilities. Group C drugs are distributed only by the NIH under NCI protocols. Although treatment is the primary objective and patients treated under Group C guidelines are not part of a clinical trial, safety and effectiveness data are collected.


Genome-Wide Association Studies