Skip to content. Skip to navigation
Personal tools
Texas A&M University
Home → Good Laboratory Practices → Glossary
Document Actions

Glossary

  1. Amendments (protocol, report) - a permanent change to a protocol or report that is documented in writing, and approved by the study director and sponsor
  2. AUP – Animal Use Protocol
  3. Critical phase – Study activities deemed by the quality assurance unit to be critical to meeting study objectives. Critical phases of each study will be determined based on the nature of the study. For example, the critical phases of a typical medical device or combination product study usually include: protocol development, animal receipt, animal identification, animal quarantine, test and control article receipt, test article & control article preparation and administration, surgical procedures, data collection procedures, daily animal observations, necropsy, histology processing, performing histomorphometry, statistical analysis, final reporting, and archiving
  4. Control articles – any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the Food, Drug, and Cosmetic Act or under sections 351 and 354-360F of the Public Health Service Act
  5. Deviation – a departure from an approved protocol, standard operating procedure, or the GLP regulations.
  6. Electronic records – any combination of text, graphics, data, audio, pictorial or information in digital form created, modified, maintained, archived, retrieved or distributed by a computer system
  7. Nonclinical laboratory studies (GLP study) – in vivo or in vitro experiments in which test articles are studied prospectively under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects, or clinical studies, or field trials in animals, and does not include studies to determine whether a test article has potential utility or to determine physical or chemical characteristics of a test article.
  8. IACUC – Institutional Animal Care and Use Committee with the responsibility of evaluating animal use protocols
  9. ORC – Office of Research Compliance
  10. Organizational unit – any department, laboratory, or facility at Texas A&M
  11. QAU - Quality Assurance Unit – any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of nonclinical laboratory studies. The quality assurance unit will monitor each study to assure testing facility management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLP regulations. For any given study the quality assurance unit must be separate and apart from the individuals involved in direction or conduct of that study.
  12. QSP - Quality System Program – processes, procedures, and controls established to ensure a high level of excellence and reliability of the data generated by the system and to ensure conformance with the regulations
  13. Raw data – any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study
  14. Sponsor – (a) a person who initiates and supports by provision of financial or other resources, a nonclinical laboratory study; (b) a person who submits a nonclinical study to the Food and Drug Administration in support of an application for a research or marketing permit; or (c) a testing facility, if it initiates, supports, and actually conducts the study
  15. Study director - the individual responsible for the overall technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results, and represents the single point of study control
  16. Texas A&M – Texas A&M University, College Station
  17. Test articles – any food additive, color additive drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the Food, Drug, and Cosmetic Act, or under sections 351 and 354-360F of the Public Health Service Act.
  18. Testing facility – an individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal entity who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies.
  19. Testing facility management - the institutional official responsible for GLP compliance and all levels of management in organizational units participating in GLP studies
  20. Test systems - any animal, plant, microorganism or subpart, thereof to which the test or control articles are administered or added for study. Test system also includes appropriate groups of components of the system not treated with the test or control articles.
  21. VPR – The Vice President for Research, Texas A&M University, College Station