Provides a separation of species or test systems; isolation of individual projects; quarantine of animals and routine or specialized housing.
What are animal rooms?
100
Current summary of training, experience and job description.
What is a Training Record (Employee Training Record, ETR)?
200
Issues a Quality Assurance Inspection Report.
Who is Quality Assurance?
200
The date the protocol is signed by the Study Director.
What is the Study Initiation Date?
200
Labeled to indicate identity, titer, or concentration, storage requirements and expiration date.
What is a reagent or solution (or drug)?
300
For non-clinical studies, person responsible for the technical conduct of the study, interpretation, analysis, documentation and reporting results and represents the single point of control.
Who is the Study Director?
300
Ear Tag, tattoo, ear punch, cage card, chip
What are methods for identifying an animal?
300
Final Document, signed and dated by the Study Director, that accurately describes the methods, draws accurate conclusions and accurately represents the raw data.
What is the Final Report?
400
Double Jeopardy: A person [establishment] who actually conducts a non-clinical laboratory study (uses the test article in a system)?
What is Test Facility?
400
Shall be adequately inspected, cleaned and maintained.
What is equipment?
400
A document that clearly states the objectives and all methods of the conduct or the study.
What is the protocol?
500
Issues a 482.
Who is the FDA?
500
Procedures in writing setting forth nonclinical study methods that management is satisfied are adequate to ensure the quality and integrity of the data generated in the course of the study.
What is a Standard Operating Procedure?
500
Any laboratory worksheets, records, memoranda, notes or exact copies thereof that are a result of original observation