CITI Good Laboratory Behavior Practice Test

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• Define raw data in GLP and why it must be preserved.
• What is a unique OECD GLP requirement for a study director?
• In GLP, CAPA is used to prevent recurrence through what process?
• How are cross-site GLP studies aligned for consistency?
• For any facility performing studies intended for FDA submission, the equipment used to generate raw data must have
• Under what conditions may properly trained personnel perform QA duties as well as technical ones?
• Which of the following must a GLP protocol include to be compliant?
• In the early GLP preambles, some items were moved from one role to another to balance responsibility. From which role to which role were they moved?
• What action could increase GLP compliance when necropsy data were withheld from a pathologist?
• What is included in a Study Director's report?
• How are protocol amendments properly managed in GLP?
• What is the purpose of an audit trail in GLP data systems?
• In a "primary eye irritation" study in rabbits, the untreated eye is referred to as which term?
• How should supplier qualification be addressed in GLP?
• Who is directly responsible for data integrity and the accuracy of final reports?
• What should GLP data records indicate regarding routine vs nonroutine procedures?
• As the G.D. Searle and IBT "landmark" cases demonstrate, an essential difference between fraud and error is:
• Which organization is responsible for developing a series on GLP principles for European nations?
• GLP tolerance relates to which aspect of residues?
• How is data integrity preserved in electronic data capture systems?
• In a very small GLP facility, who is permitted to be responsible for storing and retaining specimens and raw data?
• In OECD GLPs, the study plan is understood to be equivalent to which term used by EPA and FDA?
• In an outdoor EPA study, which sanitation precaution helps avoid contamination of the test system during harvest?
• Which red flags might indicate data manipulation in GLP studies?
• The negative findings from the G.D. Searle and Industrial Bio-Test Laboratories (IBT) cases revealed:
• How should SOP deviations be managed?
• In GLP, what does a certificate of analysis (COA) typically verify?
• How are nonclinical safety study endpoints chosen under GLP?
• What safety measures should be in place in GLP laboratories?
• How do paper records differ from electronic records in GLP validation?
• Bes-Tever, Inc. SOP #702 begins with three sections. Which section needs updating to stay current?
• The relationship of SOPs to the protocol is best understood as:
• What is the primary purpose of the QA inspections described in GLP facilities?
• What is the purpose of a change control process in GLP?
• What are key requirements for recording data to support integrity?
• A GLP memorandum of understanding between an OECD-member country and the U.S. would permit acceptance of final reports and data conducted in either country under their applicable GLP regulations. This means acceptance of data:
• Which data attribute is NOT part of ALCOA data integrity principles?
• What are the stages of equipment qualification and what do IQ/OQ/PQ mean?
• "Study Plan" and "Study Protocol" are:
• What considerations govern data archiving in GLP?
• Which statement best describes what is retained in an archive under GLP regulations?
• How should test article identity and stability be verified?
• In the protocol example, what is the CAS number associated with the test substance All-Slide3?
• The landmark cases demonstrated that fraud differs from error primarily in:
• How should GLP facilities handle waste and safety?
• Study procedures required by the protocol may conflict with which of the following?
• Which documents describe how study conduct operations and methods are to be performed?
• The environment of an animal housing room refers to which of the following?
• What are typical components of a GLP Final Report?
• How should a contributing scientist's report be handled in GLP final submissions?
• What is the role of the Quality Assurance Unit (QAU) in GLP studies?
• Which statement best captures the overall design of a quality system in GLP?
• Why must the Study Director maintain independence from QA activities?
• How do FDA and EPA GLPs differ in the definition of raw data?
• What are ALCOA principles and how do they support GLP data integrity?
• QA inspections are performed to review which aspects of a GLP study?
• Which elements define how a GLP facility should monitor environmental conditions?
• Sponsor is a term referring to a person only, unless:
• What is required to produce GLP-compliant raw data when recording observations with a voice recorder?
• The primary requirement for quality assurance unit (QAU) personnel includes:
• What is the role of CAPA in GLP deviation management?
• How should a GLP facility respond to a nonconformance finding?
• Why are regulatory audits important for GLP compliance?
• How should environmental monitoring excursions be handled in GLP studies?
• If a study is disqualified under Subpart K, can other studies from the same facility be considered?
• "Experimental Starting Date" is a definition used by which organization to mean what?
• Which of the following best describes contemporaneous data recording in GLP?
• The FDA's 21 CFR 58.3 definitions list for GLP data excludes which category?
• In GLP, who is primarily responsible for ensuring that a study is conducted according to the protocol and SOPs?
• The companies presented in this module as "landmark cases" in the establishment of GLPs were:
• Why is it important to separate animals by study using adequate differentiation?
• Who determines the adequacy of archiving procedures?
• How are deviations typically described in a Final Study Report?
• In a scenario where SDS indicates a cleaning product can be used in cold or hot water but SOP specifies hot water only, what should management do?
• What action would improve GLP compliance when pathology data is required by the protocol but was not sent with necropsy specimens?
• Which statement best characterizes GLP's legal status according to the material?
• A document used to inform and protect users of commercial products generated by chemical suppliers, including products for sanitization and cleaning of animal housing and vivarium areas, is known as:
• Which labeling feature is essential for test articles in GLP to prevent mix-ups?
• Why are audit trails important for electronic GLP records?
• If an animal care technician records room temperatures twice daily, how will this be reflected in the final reports?
• How should sponsor oversight and QA oversight interact in GLP?
• In a final report submitted to FDA or EPA, what must be done with the reports of contributing scientists?
• Which components are included in system validation for electronic GLP data?
• What are potential regulatory consequences of GLP noncompliance?
• In GLP data integrity, does the format of raw data matter in determining whether it is raw data?
• Who defines the scope and approvals for a GLP study?
• Which document governs day-to-day animal care tasks to ensure consistency?
• If a lab refrigerator used to store chemicals and prepare solutions does not generate raw data, why is an SOP necessary?
• What is the role of the sponsor's usual contract QA in coordinating between facilities?
• What does CAPA stand for in GLP contexts?
• In GLP contexts, what is the implication of data integrity as highlighted by landmark cases?
• What risk is involved when vivarium space is limited or more studies run concurrently, and how can it be mitigated?
• Which statement best describes the chain of custody for test articles?
• QA officers perform audits of which items?
• For certain European nations, OECD has developed a Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring. These principles share with the U.S. GLPs the intention to:
• Once the experimental termination date is reached for an EPA study, its protocol remains in force until what occurs?
• Which organization defines the terms in 21 CFR 58.3 that may trigger GLP data requirements?
• In a team of three technicians where only one writes the data on the form, which statement is most accurate?
• Differentiate between raw data and final study report data with examples.
• What steps should be taken when a deviation from GLP procedures is identified?
• Which unit is responsible for monitoring operations that are associated with the GLP quality system?
• Where must the batch identification be located to ensure GLP compliance for the test substance?
• Why should the Quality Assurance Unit operate independently from study conduct in GLP?
• The quality system goal of consistent output is most commonly achieved by expecting staff to follow what?
• Which of the following correctly describes the distinction between an in vivo nonclinical study and a study using cell cultures?
• To provide a single point of control during the conduct of each nonclinical study, FDA mandated:
• Which ALCOA attribute refers to recording data at the time of observation?
• In public comments, primary objection(s) to the proposed GLP regulations was:
• Who has ultimate responsibility for study conduct and data interpretation in GLP?
• Which option best reflects ALCOA as a data integrity concept?
• What word describes the kind of personnel who shall enter the archives?
• What is the purpose of collecting environmental data in GLP studies?
• Identify common GLP study roles beyond the Study Director.
• How should deviations be approved and recorded in GLP workflows?
• Which facility is explicitly listed as inspectable by the FDA in the material?
• What makes a record auditable in GLP?
• What does GxP mean and how does GLP fit in?
• During an inspection, how should a QA officer’s question be answered?
• Which GLP role is intended to provide independent oversight of study quality?
• Under GLP, which item can be considered raw data?
• How should test article labeling be designed?
• The scope of the FDA's GLP regulations for nonclinical research and testing includes:
• In GLP, a study is not considered complete until what occurs?
• An example of a common piece of lab equipment that provides measurement data but cannot be calibrated by technical staff is a glass graduated cylinder. What standard procedure should be advised to ensure it is suitable for use?
• The Animal Welfare Act is monitored by unannounced on-site inspections by employees of which agency?
• Which term correctly describes the document that informs users about chemical hazards and safe handling?
• What is the purpose of chain of custody in GLP?
• Which two roles share responsibility for data integrity and final report accuracy?
• Unannounced, on-site inspections by USDA monitor compliance with which act?
• During an EPA or FDA testing facility inspection, the technical staff is advised to:
• What elements should a calibration/maintenance log include?
• To reduce time spent changing bedding in cages, which action would be compliant with both GLPs and animal welfare regulations?
• Who provided the multiple batches of All-Slide3 received from the sponsor?
• Raw data in GLP must be accompanied by documentation that demonstrates its traceability. Which statement best describes this requirement?
• What is the difference between raw data and supporting data in GLP?
• FDA's 21 CFR 58.190 regarding commercial archives: What does it allow?
• Who has responsibility for study monitoring when the sponsor uses contract quality assurance?
• Who is the best person to make decisions about animal care or technical interactions for a group of study animals?
• What type of data entries first alerted FDA investigators to problems?
• The primary purpose for the retention of nonclinical laboratory study raw data and other associated records in an archive is to:
• When there is a discrepancy between safety guidance and the current SOP, what action aligns with maintaining a current quality system?
• One of the most important points for GLP studies is: A full description of what comprises raw data that is collected while following protocol instructions.
• In the protocol example, which piece of information uniquely identifies the batch?
• How should electronic data be validated before use in GLP?
• What is the purpose of the GLP Final Report?
• The EPA tolerance allows test results to be measured against the allowable level of residue in which units?
• What is the primary objective of GLP in nonclinical studies?
• If an operation is not routine, what additional documentation is required?
• What is a study 'test system' and why is it important?
• A GLP memorandum of understanding (MOU) between an OECD-member country and the U.S. would permit:
• Which statement best describes the common requirement for archives and the quality assurance unit?
• In GLP, the purpose of Standard Operating Procedures (SOPs) is to
• If a study technician posts an instruction on a rack to measure water consumption weekly, but the bottles are too small to hold five days of water, what should be done?
• In EPA residue tolerances, which unit is not typically used to express residue levels?
• Which document is most influential in determining the number of personnel for timely and proper conduct of a study?
• Which raw data source requires transcription and verification by the creator to be GLP-compliant?
• Nonclinical research and testing refers to that performed using:
• A technician notes significant weight loss in a rodent and discovers a malfunctioning water valve. What does this imply?
• Which of the following best describes the relationship between GLP and research facility governance, as implied by the material?
• If a staff member has had QA responsibility for a study, what restriction applies to their later work?
• Which of the following facilities may the FDA inspect?
• In GLP, what is the primary purpose of the archives for long-term storage of raw data?
• Which stage of equipment qualification verifies installation is correct according to specifications?
• What is the primary purpose of environmental health standards in GLP facilities?
• What should GLP training records demonstrate?
• Which regulatory framework governs all studies described in the material?
• What distinguishes an in vivo nonclinical laboratory study?
• For each testing facility that archives its own raw data, the procedures that describe how it will be done are:
• Why is QA independence important in GLP?
• Which statement best explains the labeling on reagent containers under GLP?
• What is a Master Record and why is it controlled?
• Which of the following is true about Good Laboratory Practice (GLP) standards?
• When a rack has a rack-specific instruction that differs from the general SOP and you lack the protocol, which instruction do you follow?
• What best describes data integrity in GLP?
• In GLP, which document should contain a full description of what constitutes raw data that is collected?
• After a weighing balance incident where the equipment was moved and a bowl fell, how could the facility's quality system be improved?
• The GLP regulations in FDA and EPA Subpart E require the same method to indicate identity, titer or concentration, storage requirements, and expiration date on containers of reagents and solutions. What is that method?
• What are the two essential requirements for all personnel engaged in or supervising any GLP study?
• How does GLP regulate the number of QA inspections required for a study?
• What should data reconciliation across sites demonstrate?
• Which of the following are raw data in the field scenario described: a photograph of plant condition and a hand-written description on a data form?
• What are essential elements of data retention and destruction procedures?
• What is a Data Handling Plan and what does it cover?
• What does CAPA stand for and how is it used in GLP?
• What is a deviation in GLP and how should it be handled?
• What training should GLP personnel complete and maintain records for?
• Which section documents regulatory compliance statements in a GLP Final Report?
• Why are SOPs essential in GLP?
• Distinguish protocol amendments from deviations and how each is documented.
• Which arrangement best enhances GLP compliance for archiving in a small facility while remaining practical?