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This exam is produced by DMSA research team to assess the knowledge of the members on the fundamentals of clinical research skills. Al-Azhar University Damietta faculty of medicine Damietta medical student association (DMSA) research team
Questions and Answers
1.
Pre-clinical research is
A.
Done on healthy human volunteers
B.
Done using lab animals
C.
Done on group of diseased human participants
D.
Developed from patient records
Correct Answer
B. Done using lab animals
Explanation Pre-clinical research is conducted using lab animals. This is because lab animals, such as mice or rats, can be used to study the effects of new drugs or treatments before they are tested on humans. This type of research helps to determine the safety and effectiveness of potential treatments and allows scientists to gather important data before moving on to human clinical trials. Using lab animals also helps to minimize the potential risks and ethical concerns associated with testing on humans.
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2.
All of the following studies have prospective design except
A.
Case-control study
B.
Randomized controlled trial
C.
Quasi control study
D.
Classical cohort study
Correct Answer
A. Case-control study
Explanation A case-control study is not a prospective design because it starts with individuals who already have a certain outcome (cases) and compares them to individuals without the outcome (controls). In contrast, all the other options listed (randomized controlled trial, quasi control study, classical cohort study) involve following individuals over time to observe the development of outcomes, making them prospective designs.
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3.
In double-blind randomized controlled trial
A.
The doctors know but the patients donāt know who is getting placebo
B.
Neither the doctor nor the patients know who is getting the placebo
C.
Both doctors and patients know who is getting placebo
D.
Patients know but the doctors donāt know who is getting placebo
Correct Answer
B. Neither the doctor nor the patients know who is getting the placebo
Explanation In a double-blind randomized controlled trial, neither the doctor nor the patients know who is getting the placebo. This is important because it helps eliminate bias and ensures that the results of the trial are objective. If either the doctor or the patients knew who was receiving the placebo, it could potentially influence their behavior or perception of the treatment, leading to biased results. By keeping both parties unaware, the trial can provide more reliable and unbiased data on the effectiveness of the treatment being tested.
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4.
A placebo is
A.
Drug pill looks the same as the drug being tested
B.
Drug bill containing the same chemicals in the drug being tested
C.
False pill contains no active ingredients and looks the same as the active pill
D.
Drug pill which has lower concentration of the active ingredients
Correct Answer
C. False pill contains no active ingredients and looks the same as the active pill
Explanation A placebo is a false pill that is designed to look the same as the active pill being tested. It does not contain any active ingredients, but its appearance is identical to the active pill. Placebos are used in clinical trials to determine the effectiveness of a new drug by comparing it to a control group that receives the placebo. This helps researchers to evaluate the true effects of the drug being tested, as any improvements observed in the active group can be compared to the improvements (or lack thereof) in the placebo group.
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5.
The most important document to enrol patients in clinical trial is
A.
Protocol
B.
Informed consent
C.
Case report form
D.
Patient marital status documents
Correct Answer
B. Informed consent
Explanation Informed consent is the most important document to enroll patients in a clinical trial because it ensures that patients are fully aware of the risks and benefits of participating in the trial. It also confirms that patients have voluntarily agreed to participate and have given their permission for their medical information to be used for research purposes. This document protects the rights and safety of the patients and allows them to make informed decisions about their participation in the trial.
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6.
For what purpose does the IRB review the informed consent?
A.
Protection of the facility
B.
Protection of the participant
C.
For documentation
D.
Protection of the sponsor
Correct Answer
B. Protection of the participant
Explanation The IRB (Institutional Review Board) reviews the informed consent to ensure the protection of the participant. Informed consent is a process where participants are provided with all the necessary information about the study, including potential risks and benefits, before they decide to participate. The review by the IRB ensures that the participant's rights and welfare are safeguarded, and that they have the necessary information to make an informed decision about their participation. This helps to protect participants from any potential harm or unethical practices during the study.
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7.
When is the primary outcome/endpoint of the trial defined?
A.
Just prior to data analysis
B.
During protocol development
C.
At randomization
D.
At final evaluation of data
Correct Answer
B. During protocol development
Explanation The primary outcome/endpoint of a trial is defined during protocol development. This is because the primary outcome is the main objective of the study and needs to be determined beforehand in order to design the study properly. Defining the primary outcome during protocol development helps ensure that the study is focused and that the data collected will be able to answer the research question effectively.
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8.
One main reason for drop-out of a new drug under clinical testing is
A.
Side effects
B.
High efficacy
C.
Drug-food interaction
D.
Secreted in urine
Correct Answer
A. Side effects
Explanation One main reason for the drop-out of a new drug under clinical testing is side effects. This means that the drug may cause adverse reactions or unwanted effects in patients, which can range from mild to severe. Side effects are carefully monitored during clinical trials to ensure the safety and tolerability of the drug. If the side effects are deemed too significant or pose a risk to patients, the drug may be discontinued from further testing or development.
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9.
The source of strongest evidence in EBM pyramid is
A.
Expert opinion
B.
Systematic review and meta-analysis
C.
Case report
D.
Randomized controlled study
Correct Answer
B. Systematic review and meta-analysis
Explanation The strongest evidence in the EBM pyramid is a systematic review and meta-analysis because it involves a comprehensive and rigorous analysis of multiple studies on a specific topic. This method combines the results of individual studies to provide a more reliable and accurate estimate of the overall effect. It helps to minimize bias and provides a higher level of evidence compared to other sources such as expert opinion, case reports, or randomized controlled studies.
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10.
Systematic review and meta-analysis methodology usually doesn’t include
A.
Screening of clinical trial articles
B.
Blinding of reviewers
C.
Data analysis
D.
Quality assessment
Correct Answer
B. Blinding of reviewers
Explanation Blinding of reviewers is not usually included in the systematic review and meta-analysis methodology. Blinding refers to the process of concealing certain information from the reviewers to minimize bias in their assessments. In the context of systematic reviews and meta-analyses, blinding of reviewers may not be feasible or necessary as the focus is on aggregating and analyzing data from multiple studies rather than evaluating individual studies. Therefore, blinding of reviewers is not a standard practice in this methodology.
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11.
The usual format of journal research article is
A.
Introduction, abstract, methods, and references
B.
Abstract, introduction, methods, results, discussion, and references
C.
Introduction, results, discussion, and methods.
D.
Introduction, Methods, results, abstract, references, and discussion
Correct Answer
B. Abstract, introduction, methods, results, discussion, and references
Explanation The correct answer is "Abstract, introduction, methods, results, discussion, and references." This is the usual format of a journal research article. The abstract provides a brief summary of the study, followed by the introduction which provides the background and context. The methods section describes the methodology used in the study, while the results section presents the findings. The discussion section interprets the results and discusses their implications. Finally, the references section lists the sources cited in the article.
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12.
The section contains details on the dosages and administration data usually is
A.
Introduction
B.
Abstract
C.
Methods
D.
Discussion
Correct Answer
C. Methods
Explanation The correct answer is "Methods" because this section of a research paper typically provides information on the dosages and administration data used in the study. It outlines the specific methods and procedures followed in the research, including how the dosages were determined and administered to the participants. The Methods section is crucial for understanding the study's methodology and replicating the research.
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13.
The section usually doesn’t need citations is
A.
Discussion
B.
Abstract
C.
Introduction
D.
Results
Correct Answer
B. Abstract
Explanation The abstract section usually does not need citations because it is a concise summary of the main points of the research paper. It provides an overview of the study's objectives, methods, results, and conclusions. Since it is a brief summary, it does not go into detail or provide specific references to support the information presented. The purpose of the abstract is to give readers a quick overview of the study's key findings and to help them determine if the full paper is relevant to their interests.
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14.
Which of the following is not a Qualitative variable
A.
Age
B.
Marital status
C.
Blood groups
D.
Gender
Correct Answer
A. Age
Explanation Age is not a qualitative variable because it can be measured quantitatively using numerical values. Qualitative variables, on the other hand, are categorical and cannot be measured numerically. Marital status, blood groups, and gender are all examples of qualitative variables as they represent categories or attributes rather than numerical values.
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15.
Which of the following is not a measure of central tendency
A.
Standard deviation
B.
Mean
C.
Mode
D.
Median
Correct Answer
A. Standard deviation
Explanation Standard deviation is not a measure of central tendency because it measures the dispersion or spread of data rather than the central or average value. Measures of central tendency, such as mean, mode, and median, provide information about the typical or central value of a dataset. In contrast, standard deviation indicates how much the data points deviate from the mean, giving insights into the variability or distribution of the data.
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16.
Standard deviation is usually used to describe data spread around
A.
Median
B.
Mean
C.
Mode
D.
P-value
Correct Answer
B. Mean
Explanation Standard deviation is a measure of how spread out the data is around the mean. It calculates the average distance between each data point and the mean. Therefore, it is commonly used to describe the data spread around the mean. The median, mode, and p-value do not provide information about the spread of the data, so they are not the correct answer.
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17.
Normal distribution curve is characterized by all of the following except
A.
Bell shaped curve
B.
Can be described by mean and standard deviation
C.
Data are not symmetrical around the mean
D.
Mean, median, and mode are equal
Correct Answer
C. Data are not symmetrical around the mean
Explanation The normal distribution curve is characterized by a bell-shaped curve, which means that the majority of the data falls near the mean and decreases as it moves away from the mean. It can be described by the mean and standard deviation, which provide information about the central tendency and spread of the data. Additionally, in a normal distribution, the mean, median, and mode are equal. Therefore, the statement "Data are not symmetrical around the mean" is incorrect as symmetry is a key characteristic of the normal distribution.
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18.
In normal distribution curve, the area represented by mean plus two standard deviations above or below (mean±2SD) contains
A.
90% of sample data
B.
50% of sample data
C.
99% of sample data
D.
95.4% of sample data
Correct Answer
D. 95.4% of sample data
Explanation In a normal distribution curve, the area represented by mean plus two standard deviations above or below (meanĀ±2SD) contains approximately 95.4% of the sample data. This is because in a normal distribution, about 68% of the data falls within one standard deviation of the mean, about 95.4% falls within two standard deviations, and about 99.7% falls within three standard deviations. Therefore, the correct answer is that 95.4% of the sample data is contained within meanĀ±2SD.
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19.
Typically to reject the null hypothesis the P-value must be
A.
Lower than 0.05
B.
Lower than or equal to 0.05
C.
Lower than or equal to 0.5
D.
Above or equal to 0.5
Correct Answer
B. Lower than or equal to 0.05
Explanation To reject the null hypothesis, the p-value must be lower than or equal to 0.05. The p-value represents the probability of obtaining the observed results (or more extreme results) if the null hypothesis is true. A p-value lower than 0.05 indicates that the observed results are unlikely to occur by chance alone, providing evidence against the null hypothesis and supporting the alternative hypothesis. This threshold is commonly used in statistical hypothesis testing to determine statistical significance.
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20.
If we are using risk ratio as effect estimate which of the following 95% confidence intervals is statistically significant?
A.
[1, 1.88]
B.
[0.5, 0.8]
C.
[0.01, 2]
D.
[0.98, 5]
Correct Answer
B. [0.5, 0.8]
Explanation The 95% confidence interval [0.5, 0.8] is statistically significant because it does not include the value of 1. In hypothesis testing, if the confidence interval includes the null value (in this case, 1), it suggests that the effect estimate is not statistically significant. However, since the interval [0.5, 0.8] does not include 1, it indicates that the risk ratio is statistically significant, meaning that there is a significant difference between the groups being compared.
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