GLP - CFR 21 Part 58

Question 1

Which Act passed by Congress is referenced as part of GLPs?

Answer 1

Federal Food, Drug, Cosmetic Act

effective June 1979

amended 1987

Question 2

Any food additive, drug, biological product, electronic product, medical device for human use, and any other material being tested is referred to in CFR 21 Part 58 as a:

a. Test Material
b. Test Article
c. Test Substance
d. Test System

Answer 2

b. Test Article

Question 3

Field trials in animals are considered part of nonclinical laboratory studies. T or F.

Answer 3

False

Question 4

A testing facility cannot be considered a Sponsor. T or F.

Answer 4

False

A testing facility can be considered a sponsor if it both initiates and conducts the study

Question 5

An animal, plant, microorganism, or subpart thereof receiving the test article is called the:

a. Test Material
b. Test Article
c. Test Substance
d. Test System

Answer 5

d. Test System

Question 6

In the event that the exact transcripts of raw data have been prepared (e.g. tapes) the exact copy or exact transcript may be substituted for the original source as raw data. T or F.

Answer 6

True

Question 7

Photographs are not considered raw data. T or F.

Answer 7

False

Question 8

Study Directors can be a part of the quality assurance unit. T or F.

Answer 8

False

Question 9

The individual responsible for the overall conduct of a nonclinical laboratory study is the:

a. Study Coordinator
b. Lead Technician
c. Facility Scientific Director
d. Study Director

Answer 9

d. Study Director

Question 10

Testing facilities may unexpectedly be inspected by which governmental agency which will look specifically at records supporting an application for a research or marketing permit.

a. USDA
b. EPA
c. FDA
d. ISO

Answer 10

c. FDA

Question 11

A current summary of the experience, training, and job description of individuals engaged in the conduct of a nonclinical laboratory study must be documented and maintained by the testing facility. T or F.

Answer 11

True

Question 12

Individuals with illnesses that may adversely affect the quality and integrity of nonclinical laboratory studies should be excluded from direct contact with test systems, test and control articles until the condition is corrected . T or F.

Answer 12

True

Question 13

Study Directors have overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results. T or F.

Answer 13

True

The study director represents the single point of study control

Question 14

Raw data is automatically given to a Sponsor at the completion of a study. T or F.

Answer 14

False

All raw data, documentation, protocols, and final reports are transferred to the archives during or at the close of the study

Question 15

Only the Study Director, and not the quality assurance unit, shall inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study

Answer 15

False

Quality assurance unit reports on integrity of the study to the study director

Question 16

Under the GLPs, testing facilities are required to have enough animal rooms to allow for the separation of __________ or test ____________.

Answer 16

species or test systems

Question 17

Food and bedding storage areas need to be _______ areas housing animals.

a. Adjacent to
b. Separate from
c. Within

Answer 17

b. Separate from

Question 18

SOP stands for what?

Answer 18

Standard Operating Procedure

Question 19

Deviations from SOPs are to be authorized by whom?

a. The Study Director
b. The Study Sponsor
c. The Testing Facility
d. The Quality Assurance Unit

Answer 19

a. The Study Director

Question 20

SOPs are needed for which item?

a. Animal Care
b. Animal Room Preparation
c. Handling animals found moribund or dead as well as necropsy
d. All of the Above

Answer 20

d. All of the Above

Question 21

T/F: Space requirements for mice, rats, guinea pigs, and NHPs are specifically stated in GLP CFR 21

Answer 21

False

Question 22

Which animals do not need identification?

a. Adult mice
b. Guinea Pigs
c. Suckling Rodents
d. Farm animals

Answer 22

c. Suckling Rodents

Question 23

What two items need to be analyzed periodically for contaminants known to be capable of interfering with studies?

1. Flooring materials
2. Paint
3. Feed
4. Water
5. Caging material

Answer 23

Feed & Water

Question 24

Which of the following animal related items do not need to be identified in a GLP protocol?

a. Coat color
b. Body weight ranges
c. Supplier
d. Species and strain/substrain

Answer 24

a. Coat color

Question 25

T/F: Pencil or ink entries are legal for raw data documentation.

Answer 25

False

Question 26

Wet specimens such as blood, urine, feces, and biological fluids do not need to be maintained after the completion of a GLP study. T or F.

Answer 26

True

Question 27

How long must raw data & training records be maintained following the date on which an application to FDA for a research or marketing permit for which the nonclinical laboratory study was done?

a. 3 years
b. 4 years
c. 5 years
d. 2 years

Answer 27

d. 2 years

Question 28

How long must raw data & training records be maintained following the date on which the results of the study were submitted to FDA in support for the application for a research or marketing permit?

a. 3
b. 4
c. 5
d. 2

Answer 28

c. 5