CLPT, M.Pharmacy, Pharmaceutical Regulatory Affairs

In vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety.

• Phase 1 clinical study

• Clinical study

• Nonclinical laboratory study

• Phase 2 clinical study

A person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study; A person who submits a nonclinical study to the Food and Drug Administration in support of an application for a research or marketing permit

• Investigator

• Sponsor

• Government agency

• Regulatory authority

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

• Investigator

• Study director

• Sponsor

• Regulatory authority

Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.

• True

• False

Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study.

• True

• False

Personnel should not take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems.

• True

• False

Personnel engaged in a nonclinical laboratory study shall wear clothing appropriate for the duties they perform. Such clothing should not be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test and control articles.

• True

• False

Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study should be included from direct contact with test systems, test and control articles and any other operation or function that may adversely affect the study.

• True

• False

Animal supply facilities: There shall be storage areas, as needed, for feed, bedding, supplies, and equipment. Storage areas for feed and bedding shall be not separated from areas housing the test systems and shall not be protected against infestation or contamination.

• True

• False

All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer or concentration, storage requirements, and expiration date.

• True

• False