Definitions & Acronyms
Adverse Drug Experience - Any adverse event associated with the use of a new animal drug, whether or not considered to be drug related, and whether or not the new animal drug was used in accordance with the approved labeling (i.e., used according to label directions or used in an extralabel manner, including but not limited to different route of administration, different species, different indications, or other than labeled dosage). Adverse drug experience includes, but is not limited to:
- An adverse event occurring in animals in the course of the use of an animal drug product by a veterinarian or by a livestock producer or other animal owner or caretaker
- Failure of a new animal drug to produce its expected pharmacological or clinical effect (lack of expected effectiveness)
- An adverse event occurring in humans from exposure during manufacture, testing, handling, or use of a new animal drug (21 CFR 514.3)
Center for Veterinary Biologics - Center in the United States Department of Agriculture, Animal and Plant Health Inspection Service (USDA-APHIS) that regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective.
Center for Veterinary Medicine (CVM) - Center within the U.S. Food and Drug Administration (FDA), which is part of the United States Department of Health and Human Services (DHHS). The Center for Veterinary Medicine:
- Develops and recommends the policy of the Agency with respect to the safety and effectiveness of animal drugs, feeds, feed additives, veterinary medical devices (medical devices for animal use), and other veterinary medical products, and in cooperation with other Agency components, provides policy development and direction on environmental impact matters;
Evaluates, for animal safety and effectiveness, proposed and marketed animaldrugs and feed additives and marketed veterinary medical devices;
Coordinates the veterinary medical aspects of Agency inspectional and investigational programs and provides veterinary medical opinions in drug hearings and court cases; and,
- Plans, directs, and evaluates the Agency's surveillance and compliance programs relating to animal drugs, feeds, feed additives, veterinary medical devices, and other veterinary medical products (CVM Policy and Procedures Manual, 2012).
Clinical Trial - A positive-outcome driven study using client-owned target species to evaluate the effect and/or safety of therapeutic interventions, devices, and diagnostic techniques for future use in veterinary or human medicine. Types of clinical trials include:
- Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
- Natural history studies provide valuable information about how disease and health progress.
- Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning.
- Quality-of-life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life for animals afflicted with a chronic illness.
- Screening trials test the best way to detect certain diseases or health conditions.
- Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy (NIH).
Clinical Trial Review Board (CTRB) - Committee that reviews protocols for clinical trials using Veterinary Medicine Teaching Hospital (VMTH) patients
Contracting Services - A three-part unit within UCD's Materiel Management that provides timely, professional procurement and business contracting services enabling our customers to meet their business objectives consistent with the University’s mission of teaching, research, and public service. This office provides sound business contracting advice; develop sources of supply, specifications, procurement documents and business agreements using technical and professional expertise. Contracting Services is divided into three areas: Business Contracts, Purchasing and Strategic Sourcing.
Contract Research Organization (CRO) - A person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor (e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration) (21 CFR 511.3).
Copyright - An exclusive right granted or conferred by the government on the creator of a work to exclude others from reproducing it, adapting it, distributing it to the public, performing it in public, or displaying it in public. Copy right does not protect an abstract idea; it protects on the concrete form of expression in a work. To be valid, a copyrighted work must have originality and possess a modicum of creativity.
Enrollment - Patients, whose owners have consented, that have met formal inclusion and exclusion criteria, and are scheduled to participate/are participating/or have participated in the trial in accordance with the protocol.
Extralabel use - Actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses (21 CFR 530.3).
Informed Consent - The process by which an owner gives their permission to allow their animal to participate in a clinical trial
Informed Consent form - A legally-binding document that outlines the key facts of a study in layman's terms that and requires the pet owner's signature prior to the animal's participation in a study
Innovation Access - Formerly known as Technology Transfer, this service unit within the Office of Research assists researchers with intellectual property, such as inventions, patents, confidentiality agreements, transferring research materials (e.g., via material transfer agreements or MTAs), or starting a company.
Institutional Animal Care and Use Committee (IACUC) - Federally-mandated committee that oversees the institution's animal program, facilities, and procedures. The IACUC reviews the university’s program for the humane care and use of animals used in research and teaching, the status of the institution’s animal facilities, and Animal Care and Use Protocols.
Institutional Biosafety Committee (IBC) - This committee provides oversight of campus and UC Davis Health System research, teaching, and related activities that involve recombinant DNA technology, infectious agents, and other biohazardous materials.
Intellectual property (IP) - Intangible personal property that is produced from one's intellect (e.g., patents, copyrights, trademarks, and trade secrets).
Interdisciplinary Research Support (IRS) - Service unit in the Office of Research that coordinates the development and preparation of interdisciplinary research activities at UC Davis, and serves as a key partner to faculty in the pursuit of major collaborative research initiatives that take shape at the frontiers and intersections of academic disciplines.
Inventorship - The determination of who rightfully should be listed as an inventor on a patent. Unlike authorship of journal articles, inventorship has legal ramifications. Incorrect inventorship can cause a patent to be declared invalid. To be an inventor, one has to demonstratably contribute to at least one claim in a patent.
Investigational New Drug (IND) - A new drug or biological drug that is used in a clinical investigation
Investigational New Drug Application (INDA) - The application, filed by the sponsor with the Food and Drug Administration (FDA) to conduct human clinical trials, which includes a detailed descriptions of all phases, protocols, IRB members, and investigators. Once clinical evaluation is completed, a new drug application must be submitted to FDA to obtain approval to market the drug.
Investigator - An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team (21 CFR 511.3)
License - The means by which the owner of a patent gives permission to another person to carry out an action which, without such permission, would infringe on the patent. A license can thus allow another person to legitimately manufacture, use or sell an invention protected by a patent. In return, the patent owner will usually receive royalty payments.
Material Transfer Agreement (MTA) - A legal document defining the conditions under which research or other materials can be transferred and used among research laboratories.
New Animal Drug - Any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed, —
- The composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; except that such a drug not so recognized shall not be deemed to be a “new animal drug” if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or
- the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
Provided that any drug intended for minor use or use in a minor species that is not the subject of a final regulation published by the Secretary through notice and comment rulemaking finding that the criteria of paragraphs (1) and (2) have not been met (or that the exception to the criterion in paragraph (1) has been met) is a new animal drug (21 USC § 321)
New Animal Drug Application (NADA) - Application used to seek approval of a new animal drug and includes any subsequent supplemental applications made to an approval (FDA).
Office of Laboratory Animal Welfare (OLAW) - NIH office overseeing compliance with the PHS Policy on Humane Care and Use of Laboratory Animals
Office of New Animal Drug Evaluations (ONADE) - Office in the U.S. Food and Drug Administration (FDA) that reviews information submitted by drug sponsors who want approval to manufacture and market animal drugs
Patent - A patent is an intellectual property right issued by authorized bodies to inventors to make use of, and exploit their inventions without competition for a limited period of time (generally 20 years from the time of filing). The patent holder has the legal authority to exclude others from commercially exploiting the invention (for a limited time period). In return for the ownership rights, the applicant must disclose the invention for which protection is sought.
Patent Application - Papers comprising petition, specification, drawings (when required), one or more claims, oath or declaration and filing fee, whereby an applicant seeks a patent.
Patent Claims - The definition of the monopoly rights that the applicant is trying to obtain for the invention. The claims become the actual monopoly that is given when the patent is granted. A patent consists of a specification and one or more claims. Each claim defines the invention by its boundaries. A valid claim is one which reads on the invention described in the specification but does not read on any prior art.
Patentability - The ability of an invention to satisfy the legal requirements for obtaining a patent. The basic conditions of patentability are that the invention must be novel, contain an inventive step (or be non-obvious), be capable of industrial application and not be in certain excluded fields (e.g. scientific theories and mathematical methods are not regarded as inventions and cannot be patented).
Prior Art - Previously used or published technology that may be referred to in a patent application or examination report: (a) In a broad sense, technology that is relevant to an invention and was publicly available (e.g. described in a publication or offered for sale) at the time an invention was made, or (b) in a narrow sense, any such technology which would invalidate a patent or limit its scope. The process of prosecuting a patent or interpreting its claims largely consists of identifying relevant prior art and distinguishing the claimed invention from that of the prior art.
Protocol - Formal description of the study design
Provisional Patent Application - A provisional application for patent is a U. S. national application for patent filed in the USPTO. It allows filing without a formal patent claim, oath or declaration, or any information disclosure (prior art) statement. It provides the means to establish an early effective filing date in a nonprovisional patent application and automatically becomes abandoned after one year. During this year a non-provisional patent application can be filed. It also allows the term "Patent Pending" to be applied.
Reduction to Practice - The physical part of the inventive process that completes and ends the process of invention. After a reduction to practice, the invention is complete for patent law purposes.
Research Compliance and Integrity - Administrative unit in the Office of Research that provides administrative support for different areas of research including (but not limited to) research ethics, research misconduct and stem cell research oversight (SCRO).
Sponsor - A person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators (21 CFR 511.3).
Sponsor-Investigator - An individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor (21 CFR 511.3).
Sponsored Programs Office (SPO) - Office within the Office of Research that supports campus researchers and their staff with a variety of extramural funding transactions. This office is responsible for the effective and timely handling of all research proposals, as well as preparing, interpreting, negotiating, and accepting awards/agreements on behalf of the Regents for projects funded by federal and state agencies, foundations, and other public and private sources. The office is also responsible for drafting, negotiating, and executing awards and subawards for collaborative research. Dedicated analysts within the Sponsored Programs office carry out these duties. Each analyst is part of a team (led by a Contracts and Grants Officer) and is assigned to focus on either proposals or awards/subcontracts for a set of schools and/or colleges. To ensure a depth of knowledge in the department, analysts are required to cross-train in both proposals and awards/subcontracts.
Stem Cell Oversight Committee (SCRO) - Committee that reviews the use of human adult and embryonic stem cell research at UC Davis and the UC Davis Health System.
Substantial Evidence (for a New Animal Drug Application) - Evidence consisting of one or more adequate and well-controlled studies, such as a study in a target species, study in laboratory animals, field study, bioequivalence study, or an in vitro study, on the basis of which it could fairly and reasonably be concluded by experts qualified by scientific training and experience to evaluate the effectiveness of the new animal drug involved that the new animal drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. Substantial evidence shall include such adequate and well-controlled studies that are, as a matter of sound scientific judgment, necessary to establish that a new animal drug will have its intended effect (21 CFR 514.4).
Technology Transfer - Sharing of knowledge and facilities among federal laboratories, industry, universities, government, and others to make federally generated scientific and technological advances accessible to private industry and state and local governments.
- (1) A word, slogan, design, picture, or any other symbol used to identify and distinguish goods.
- (2) Any identifying symbol, including a word, design, or shape of a product or container, that qualifies for legal status as a trademark, service mark, collective mark, certification mark, trade name or trade dress.
Trademarks identify the seller of the goods and distinguish them from goods sold by others. They signify that all goods bearing the mark come from or are controlled by a single source and are of an equal level of quality. A trademark is infringed by another if the second use causes confusion of source, affiliation, connection or sponsorship. For example, UC Davis’ Gunstock is a Trademark of UC Davis.
Trade Secret - Trade secrets are information that companies keep secret to give them an advantage over their competitors. The formula for Coca-Cola is the most famous trade secret. Trade secrets are not protected by intellectual property law in the same way that trademarks or patents are. Protection for trade secrets is done by non-disclosure, the information must be kept confidential. Educational Institutions typically do not keep Trade Secrets.
Translational Research - Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science.
- UCD Office of Research: Research Administration Glossary
- UCD Comparative Cancer Center: Guide to Cancer Terms
- NIH Glossary of Terms
- Food and Drug Administration: Drug Development and Review Definitions
- International Conference on Harmonisation (ICH) Good Clinical Practices (GCP) glossary
- Code of Federal Regulations: Definition subparts
- Glossary of Intellectual Property and Licensing Terms