Welcome to the Quiz on Clinical Research

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Informed consent is:
The Form FDA 1572 is also known as the __________ form:
The key theme in the analysis of safety data is one of the combination of qualitative analysis, quantitative analysis, and __________:
It is the responsibility of the _________ to prepare the final and the clinical study report and submissions of the same to the regulatory agencies.
A _________ random sample is one in which each individual in the population has an equal chance of being drawn.
An IND is said to be ‘in effect’ ___ days after the receipt of the IND by the FDA if it is not placed on ‘clinical hold’ by the FDA:
As per the WHO guidelines there are ____ WHO Registration Datasets that a study needs to fulfill in order to consider a given trial fully registered.
The randomization of a patient to a treatment group and administering or providing the actual treatment to the patient usually occurs at _______
In Japan, a sampling survey of patients has to be conducted for _____ years after drug approval, and reports sent annually:
Sponsor should have strict accountability records and make them available upon request to authorized employees of _____ for inspection if it falls under the controlled substance category:
According to ICH Guidelines (E 11), The paediatric population represents a ________. Therefore, special measures are needed to protect the rights of paediatric study participants and to shield them from undue risk.'
E6(R1) states that the EC should have a minimum of ___ members.
25% of active cases, the infection moves from the lungs, causing other kinds of TB, collectively denoted _________ tuberculosis.
In 1986, the WHO, in the Ottawa Charter for Health Promotion, said that health is "____________, not the objective of living.
The Drugs and Cosmetics Act, 1940 rules were officially announced in 1945 however the enforcement started in ______.
Defining the regulatory role of the US government, the NDA process was prompted by:
A pharmaceutical company asserts that its new drug is definitely more effective than the existing drug in the market for controlling lipid levels. If you want to verify this claim, your null hypothesis would be:
Laissez-faire approach is concerned very much with:
Case-control studies are relatively simple and economical to carry out and are increasingly used to investigate________.
CFR Title 21 Part 50 includes