CLPT, M.Pharmacy, Pharmaceutics; Regulatory Affairs Quiz
Preview:
The IB should be reviewed at least ……………….. and revised as necessary in compliance with a sponsor’s written procedures.
A. Half yearly
B. Annually
C. Quarterly
D. Two years
The IMPD should also provide data from nonclinical trials and any information on the previous clinical use of the IMP or justify in the application why information is not provided.
A. TRUE
B. FALSE
The IB also provides insight to support the clinical management of the trial ……………… during the course of the clinical trial.
A. Applicant
B. Sponsor
C. Investigator
D. Subjects
‘IB’ also contain Nonclinical Pharmacology information.
A. TRUE
B. FALSE
The IB is a compilation of the ………………… data on the investigational product that are relevant to the trial of the product in human subjects.
A. Clinical and nonclinical
B. Nonclinical
C. Clinical
D. None
‘IMPD’ means:
A. Investigational Medicinal Process Dossier
B. Investigational Medicinal Product Dose
C. Investigational Medicinal Product Dossier
D. Investigational Medicinal Product Disease
Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration, and safety monitoring procedures.
A. TRUE
B. FALSE
‘IB’ do not contain Physical, Chemical, and Pharmaceutical Properties and Formulation, details.
A. TRUE
B. FALSE
‘IB’ also contains Pharmacokinetics and Product Metabolism in Humans, information.
A. TRUE
B. FALSE
IMPD should contain nonclinical pharmacology and toxicology data including summaries of nonclinical pharmacology and toxicology data for any IMP to be used in the clinical trial or justify why they have not.
A. TRUE
B. FALSE
The Investigator’s Brochure (IB) is an important document, which is required as a part of the IND.
A. TRUE
B. FALSE
‘IB’ means:
A. Investment Bond
B. Investigator’s Bond
C. Investigator’s Brochure
D. Investment Brochure
Generally, the ……………….. is responsible for ensuring that an up-to-date IB is made available to the investigator(s).
A. IRB
B. USFDA
C. sponsor
D. Trail subject
The IMPD should contain information to justify the quality of any Investigational Medicinal Product (IMP) to be used in a clinical trial and include information on reference products and placebo.
A. TRUE
B. FALSE
An IMPD should not include summaries of information related to the quality, manufacture, and control of the IMP.
A. TRUE
B. FALSE
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