Glossary of Terms
Expand your clinical research understanding by exploring the terms and acronyms that we function with everyday. Seems simple right? But, there are so many things that we don’t know and others that we need to know better.
“People do the best with what they know – when they know better they do better!”
- Maya Angelou |
Bioavailability
Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body.
Biologic
A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man.
National Research Act
Act created by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research in 1974 and mandated review of studies by institutional review boards and subject protection by informed consent.
Nuremberg Code
As a result of the medical experimentation conducted by Nazis during World War II, the U.S. Military Tribunal in Nuremberg in 1947 set forth a code of medical ethics for researchers conducting clinical trials. The code is designed to protect the safety and integrity of study participants.
Off-label
The use of an approved drug to treat conditions other than those approved by the FDA.
Orphan Drug
A designation of the FDA to indicate a therapy developed to treat a rare disease (one which afflicts a U.S. population of less than 200,000 people). Because there are few financial incentives for drug companies to develop therapies for diseases that afflict so few people, the U.S. government offers additional incentives to drug companies (i.e. tax advantages and extended marketing exclusivity) that develop these drugs.
Protection of Pupil Rights Amendment (PPRA) Department of Education regulation that states that surveys, uestionnaires and instructional materials for school children must be nspected by parents/guardians.
Protocol
A detailed plan that outlines the objectives, procedures, interventions, and eligibility criteria for a clinical trial. The full protocol must be completed and approved before a clinical trial can begin.
Randomization
Study participants are usually assigned to groups in such a way that each participant has an equal chance of being assigned to each treatment (or control) group. Since randomization ensures that no specific criteria are used to assign any patients to a particular group, all the groups will be equally comparable.
Research Misconduct
Fabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. The term does not include honest error or honest differences of opinion.
Standard Operating Procedure (SOP)
Official, detailed, written instructions for the management of clinical trials. SOPs ensure that all the functions and activities of a clinical trial are carried out in a consistent and efficient manner.
Vulnerable Subjects
Groups of people who could be particularly pressured to join a clinical trial. The groups include people with limited ability to make informed decisions (such as children and individuals with mental illness) or people in sensitive situations (such as a researcher's employees or students).
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