Clinical Research Assessement by ClinSkill | Nov 11, 2018 | 1 comment Welcome to the Quiz on Clinical Research Name Email address CFR Title 21 Part 50 includes Informed consent form NDA regulations IND regulations IRB Laissez-faire approach is concerned very much with: CROs Sponsors Regulatory Agencies Investigators It is the responsibility of the _________ to prepare the final and the clinical study report and submissions of the same to the regulatory agencies. Sponsor SMO CRO Investigator Case-control studies are relatively simple and economical to carry out and are increasingly used to investigate________. Incidence of disease Causes of diseases Prevalence of disease All of these 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: The new drug has more efficacy than the existing drug The new drug has same efficacy as the existing drug The new drug has no effect The new drug has less efficacy than the existing drug In 1986, the WHO, in the Ottawa Charter for Health Promotion, said that health is "____________, not the objective of living. Day to day concern of life A resource for everyday life State of Mind of an individual on a day to day basis None of these In Japan, a sampling survey of patients has to be conducted for _____ years after drug approval, and reports sent annually: Three Two Five Six Ten Defining the regulatory role of the US government, the NDA process was prompted by: Pure Food & Drugs Act (1906) Sherley Amendment (1912) Federal Food, Drug and Cosmetic Act (1938) All of these 25% of active cases, the infection moves from the lungs, causing other kinds of TB, collectively denoted _________ tuberculosis. Secondary Pulmonary Extra pulmonary Intra pulmonary None of these The Drugs and Cosmetics Act, 1940 rules were officially announced in 1945 however the enforcement started in ______. 1947 1995 1956 1940 The Form FDA 1572 is also known as the __________ form: Clinical Trial Good Clinical Practice Abiding Statement of Investigator Investigator 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.' Major subgroup Dependent subgroup Vulnerable subgroup Risky subgroup 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. 30 40 20 10 E6(R1) states that the EC should have a minimum of ___ members. Twelve Seven Five Three A _________ random sample is one in which each individual in the population has an equal chance of being drawn. Compound Complex Primary Simple Informed consent is: Obtained from the patient at visit 1 only Obtained from the patient at visit 1 but the process continues till the end of the study Obtained anytime before study completion Obtained only if the patient requests for it The key theme in the analysis of safety data is one of the combination of qualitative analysis, quantitative analysis, and __________: Subjective analysis Clinical interpretation Both of these None of these 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: 15 120 30 60 45 The randomization of a patient to a treatment group and administering or providing the actual treatment to the patient usually occurs at _______ Informed Consent Process Visit 1 Screening None of these 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: Drug Enforcement Agency (DEA) Sponsor CRO None of the above Time's up 1 Comment Millicent Ouma on November 12, 2018 at 8:30 am Nice questions though some were specific to regulations in the US. I am Kenyan:) Reply Submit a Comment Cancel replyYour email address will not be published. Required fields are marked *Comment * Name * Email * Website Save my name, email, and website in this browser for the next time I comment.
Nice questions though some were specific to regulations in the US. I am Kenyan:)