The date that the Study Director signs the protocol according to the FDA, EPA and OECD.
What is the study initiation date?
100
A document that describes all the parameters of a study including all tests, objective, design, methodology, statistical considerations and organization of a study.
What is the protocol?
100
Appoints the Study Director and promptly replaces the Study Director when necessary.
Who is Testing Facility Management?
100
Where all specimens, data and final report are retained after the finalization of the study.
What is archives?
200
The "L" stands for.
What is Legible?
200
The date that the Study Director signs the final report according to the FDA, EPA and OECD.
What is the study completion date?
200
The name of the document for all changes or revisions to an approved protocol.
What is an amendment?
200
Has overall responsibility for the 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.
Who is the Study Director?
200
What the FDA or EPA gives a facility for not complying with the regulations.
What is a 483?
300
The "C" stands for.
What is Contemporaneous?
300
Any animal, plant, microorganism to which the test or control article is administered or added for study.
What is the test system?
300
The name of the document for an unplanned change to an approved protocol or SOP.
What is a deviation?
300
Personnel who are not involved in study conduct but integral to GLP verification.
Who is Quality Assurance (QA)?
300
**DAILY DOUBLE**
See Slides
400
The "O" stands for.
What is Original?
400
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.
What are raw data?
400
Documented procedures which describe how to perform test or activities not specified in detail in the protocol.
What are Standard Operating Procedures (SOPs)?
400
A person that initiates and supports a study, by provision of financial or other resources, a non-clinical laboratory study.
Who is the Sponsor?
400
Personnel that are required to sign the final report.
Who are the Study Director and Quality Assurance?
500
The second "A" stands for.
What is Accurate?
500
A person or organization that conducts a non-clinical laboratory study.
What is the Testing Facility?
500
A set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.
What are Good Laboratory Practices (GLPs)?
500
The person responsible to ensure data gets transferred to archives at the end of a study.
Who is the Study Director?
500
The four steps to correcting an error in the records.
What are: 1. Lining out the error, 2. Documenting the correct entry 3. Documenting the reason for the change 4. Initial and dating the correction?