Study Personnel
What shall each testing facility maintain for each individual engaged in or supervising the conduct of a nonclinical laboratory study?
A current summary of training and experience(CV), and job description
what can be described as in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals.
Nonclinical Laboratory Study
what documented procedures describe how to perform tests or activities normally not specified in detail in study plans or test guidelines ?
Standard Operating Procedures
What is the date called when the Study Director signs the final study report?
Study completion date
What are at least three examples of required SOPs under CFR825 GLP regs?
(1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles. (4) Test system observations. (5) Laboratory tests. (6) Handling of animals found moribund or dead during study. (7) Necropsy of animals or postmortem examination of animals. (8) Collection and identification of specimens. (9) Histopathology. (10) Data handling, storage, and retrieval. (11) Maintenance and calibration of equipment. (12) Transfer, proper placement, and identification of animals.
Who is the person or organizational element, besides the study director, designated by testing facility management to perform the duties relating to quality assurance of nonclinical laboratory studies.
Quality Assurance Unit
What can be described as any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act.
Test Article
what can be described as 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
Raw Data
what is an intended change to the study plan after the study initiation defined as?
Study Amendment
Who inspects each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection.
Quality Assurance Unit
Who is the person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study
Study Sponsor
what can be described as any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any article other than a test article, feed, or water that is administered to the test system in the course of a nonclinical laboratory study for the purpose of establishing a basis for comparison with the test article.
Control Article
What are the guidelines that one follows in recording raw data entries in legible, traceable and reproducible manner? Examples might include: BOMs, Batch records, and analytical methods.
Good Documentation Practices(GDP)
What is an unintended departure from the study plan after the study initiation date?
Study Deviation
How is raw data being corrected; is GDP being followed?
Single line through the error with circled footnote number, corresponding footnote on back with details of the correction, initialed and dated
who is the individual responsible for the overall conduct of a nonclinical laboratory study
The study director
what is any animal, plant, microorganism, or subparts thereof to which the test or control article is administered or added for study. This also includes appropriate groups or components of the system not treated with the test or control articles.
What is a Test System
Who signs the final report of a study?
Study Director
What is the date called when the Study Director signs the study protocol?
Study Initiation Date
Which SOP details correction of raw data?
Auditing protocols and protocol amendments
Who is the person(s) who has the authority and formal responsibility for the organization and functioning of the test facility according to these Principles of Good Laboratory Practice
Test Facility Manager
Who do we report work related health illnesses to?
Occupational Health and Safety Officer
Which personnel must be listed on a Study Protocol?
The name of the study director, the names of other scientists or professionals, and the names of all supervisory personnel involved in the study.
What are two things that must be ensured when handling test and control articles?
There is proper storage, distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage, proper identification is maintained throughout the distribution process, and the receipt and distribution of each batch is documented
Which two forms do we use to report SOP deviations?
GLP notification google form and GLP deviations and escalations