1. A phase 4 trial evaluates:

Dosage

Delivery mechanisms

Short term safety

Long term safety

2. The process to assign patients without bias to different patient groups in a clinical trial is called:

Allocation

Assignment

Randomization

Blinding

3. The use of serially numbered opaque sealed envelopes is a method for

Allocation concealment

Randomization

Blinding

Interventional compliance

4. Analysis by intention to treat is carried out without considering all of the following except:

Protocol deviation

Allocation assignment

Compliance

Withdrawal

5. A trial can be stopped before completion because of

Unacceptable side effects

Fraud or misconduct

Treatment arm is convincingly different

All of the above

6. An example of an analytical study design is

Case series

Case control

Cross-sectional

Ecological

7. A case control study:

May begin with exposure

Always begins with exposure

May begin with disease

Always begins with disease

8. Multiple outcomes are best studied in

Randomized controlled trial

Case-control study

Cohort study

None of the above

9. When the period of follow up in a study varies, appropriate analytic techniques include

Survival analysis, which predicts probability of an event at any point in the study

Proportional hazards model which provides a hazard ratio, similar to relative risk

Both of the above

Neither of the above

10. The advantages of a cohort study are all of the following except:

Ability to assess incidence

Ability to assess rare exposures

Ability to assess rare outcomes

Ability to study temporality between exposure and outcome

11. Which of the following is not included in the Bradford­Hill criteria for assessing causality

Consistency

Sensitivity

Specificity

Temporality

12. If 400 people are surveyed and 40 are found to have hypertension, the survey has measured

Disease frequency

Disease probability

Disease incidence

Disease prevalence

13. Incidence rates can be best calculated in

Case series

Case control studies

Cohort studies

Randomized controlled trials

14. A random error:

Is transient, inconsistent and cannot be corrected

Is not affected by sample size

Can be controlled by increasing accuracy

Can be corrected by adjusting for the error in measurement

15. Sources of variation in measurement may arise from:

Instrument

Observer

Biologic differences

All of the above

16. James Lind carried out the first controlled clinical trial. The disease he studied was

Pellagra

Rickets

Scurvy

Angular chelitis

17. Critical evaluation of the quality of study requires all of the following except

An understanding of study design

An understanding of analysis methods

An ability to reproduce the study

An ability to assess the strength of evidence

18. Translational research is

Cycling of research and feedback from laboratory to clinic to laboratory

Development of potential new therapeutic modalities

Evaluation of safety and efficacy of treatment

Research conducted in an area with a predominantly different language

19. Preclinical research refers to

Testing of new products before marketing

Testing of drug levels in patients to determine optimal dose

Development of potential new therapeutic modalities

Development of methods for evaluation of efficacy

20. An independent variable in a study:

Is a parameter that can be determined or manipulated at the outset

Is an outcome that is determined by an unbiased observer

Cannot be determined by inclusion and exclusion criteria

Can only be a single variable

21. T-tests are most useful for what type of data

Continuous

Ordinal

Nominal

Binary

22. Level of measurement for the variable temperature is

Nominal

Ordinal

Interval

Ratio

23. If the grading of diabetes is classified as mild, moderate and severe the scale of measurement used is

Interval

Nominal

Ordinal

Ratio

24. Appropriate graphical representation for the discrete data is

Bar graph

Histogram

Line chart

None of the above

25. Variables which can be experimentally manipulated by an investigator are called:

Dependent variables

Independent variables

Confounding variables

Extraneous or secondary variables

26. Suppose that the probability of event A is 0.2 and the probability of event Bis 0.4. Also, suppose that the two events are independent. Then is

0.2

0.2/0.4 1/2

x 0.08

None of the above

27. A sampling distribution is the probability distribution for which one of the following:

A sample

A sample statistic

A population

A population parameter

28. Which of the following statements best describes the relationship between a parameter and a statistic

A parameter has a sampling distribution with the statistic as its mean

A parameter has a sampling distribution that can be used to determine what values the statistic is likely to have in repeated samples

A parameter is used to estimate a statistic

A statistic is used to estimate a parameter

29. Which of the following is the most coIrtmon example of a situation for which the main parameter of interest is a population proportion

A binomial experiment

A normal experiment

A randomized experiment

An observational study

30. The expected value of a random variable is the:

Value that has the highest probability of occurring

Mean value over an infinite number of observations of the variable

Largest value that will ever occur

Most common value over an infinite number of observations of the variable

31. Which one of these variables is a binomial random variable?

Time it takes a ranClomly selected student to complete a rri.ultjplechoice exam

Number of textoooks'arandomly selected student bought this'term

Number of women taller than 68 inches in a random sample of 5 women

Number of CDs a randomly selected person owns

32. Hallmark of the qualitative study is

It is contextual and the context is studied

It is subjective and acknowledges this truth

It is often naturalistic and interpretIve

All of the above

33. A sample mean is a estimate and we do not know how close it is to the population mean.

Point

Sample

Distribution

Confidence

34. Which of the following is a measure based on every item of the observation?

Mode

Standard Deviation

Range

Quartile Deviation

35. Which one of the following is stronger correlation?



0.98

0.0

0.5

36. In a single-factor ANOVA, the computed value of F will be zero when

There is no difference in the treatment means

There is no difference in the block means

The data are skewed left

F will never be zero

37. To test whether or not two population variances are equal, the appropriate distribution is

Z distribution

Chi-square distribution

F distribution

T distribution with n1 +n2 degrees of freedom

38. Error deviations measure distances:

Within groups

Between groups

Both and

None of the above

39. A larger sample size is required when:

The population of interest for a study is less diverse

A low level of precision is required

The population of interest is easily recruited to the study

High level of precision is required

40. Representative sample is used so that the results of a study are:

Reliable

Generalisable

Convenient

Limited

41. Statistical test allows us to make inference based on which of the following

Standard Deviation

Population

Sample

All of the above

42. A random sample is expected to approximate a normal distribution because:

A small sample size is not an issue

There are equal numbers of below and above average cases

The sample will contain mainly average cases

The goal is to maximise the sampling error

43. The population from which the study sample is selected is called the

Accessible population

Target population

Total population

Universal population

44. A clinical trial is more valuable when:

Sensitivity and Specificity have higher values

Sensitivity is higher than specificity

Specificity is higher than sensitivity

The sensitivity and specificity values are close, even equal, regardless of their values

45. In which of the following conditions, there is no need for informed consent from patients

Vaccination

Abortion

Research on children

Incompetence adults

46. A research team is evaluating the prevalence of diabetes patients presenting to a community hospital. All patients presented to the hospital are prospectively analyzed, and the percentage of diabetes is determined during a period of one month. Which of the following term describe this study?

Case-control study

Case report

Cohort study

Cross-sectional study

47. A multi-center clinical trial in lung cancer is comparing traditional treatment, and a new treatment protocol. The remission rates are found to be similar for both traditional treatment and the new one.P value is 0.45. Which of the following conclusion can be reached

Both traditional and new drugs are effective in lung cancer

Not enough information to have conclusion

Neither is effective

Statistical power of the study is 55%

48. A prospective or longitudinal study is the same as which of the following terms

Cohort study

Cross-sectional study

Case-control study

Randomized controlled trial

49. Which of the following is not an essential element of report writing

Research Methodology

Reference

Conclusion

None of these

50. Testing a hypothesis is a

Inferential statistics

Descriptive statistics

Data preparation

Data analysis

PART

Write short notes (in about 200-300 words) on any four of the following.

51. Measures of Central Tendency

52. Graphical Presentation of data

53. Assessing strength of evidence in clinical research

54. Odds Ratio of Relative Risk

55. Chi-Square Test