UNIT I - Clinical trials:

Introduction

Historical perspective,

Different phases of clinical trials

MCQs - 1 Mark

1. If a study was described as a "Dose-tolerance study" which of the following is it most likely to
be?
A.Human Pharmacology
B. Therapeutic Exploratory
C. Therapeutic Confirmatory
D. Therapeutic Use
2. Characterisation of a drug's absorption, distribution, metabolism, and excretion is usually referred to
as?
A.Efficacy
B. Safety
C. Pharmcokinetics
D. Pharmacodynamics
3. Which type of study would most likely be used to identify less common adverse reactions?
A.Human Pharmacology
B. Therapeutic Exploratory
C. Therapeutic Confirmatory
D. Therapeutic Use
4. Which phase of trial is usually considered to start with the initiation of studies in which the primary
objective is to explore therapeutic efficacy in patients?
A. Phase I
B. Phase II
C. Phase III
D. Phase IV
5. Which of the ICH E Guidelines is titled Choice of Control Group and Related Issues in Clinical
Trials?
A. E7
B.E8
C. E9
D. E10

6.In addition to the EU, US and Japan which other countries subscribe to the ICH E6 addendum.
A. Australia and Switzerland
 B. Australia and Canada
C. Switzerland and Canada
D. No other countries subscribe
7. When was ICH established?
A.1985
B. 1990
C.1994
D.1996
8. Which countries/regions were originally involved in ICH?
A. US and EU only
B. US and Japan only
C. US, EU and Japan
D. US, EU, Japan and Canada
9. When did ICH change its name to the International Council for Harmonisation?
A.2015
B.1996
C. It didn't - it's always been called this
D. It didn't - it's called the International Conference on Harmonisation

LONG ESSAY - 10 Marks

A. Describe Belmont report, Helsinki Declaration and Nuremberg code.

B. Explain different phases of clinical trials.

SHORT ESSAY - 5 Marks

A. Describe Phase-II and Phase-III of clinical trial.

B. Define adverse drug reaction and explain in which phase of clinical trial it will evaluate.
C. Describe Post-marketing surveillance.
D. Describe Nazi report.
E. Describe Elixir sulfanilamide disaster.
F. Explain HIPPA.
G. Describe the types of clinical trials in detail.

UNIT I I - Ethical issues in clinical research – IRB/IEC, Schedule Y guidelines

MCQs - 1 Mark

1. How many members should ethics committee have?

A.3 B. 5
C.7 D. There is no specification
 2. Which of the following is NOT a requirement for Ethics Committees under ICH GCP?
A. They should have SOPs
B. They should have one member who is independent of the trial site
C. Members should not be paid.
D. They should make decisions about approvals only at meetings
3. Which of the following would NOT be considered a lay person for the purposes of Ethics Committee
membership?
A. A nurse
B. An accountant
C. A clergyman
D. A social worker
4. What is the role of an IRB/IEC?
A. To design the protocol for a clinical trial
B. To assess whether a clinical trial is ethical to perform in the given subject population
C. To analyse the data from a clinical trial
D. To assess whether a medicinal product should be granted a marketing authorisation

LONG ESSAY - 10 Marks

A. Describe in detail about IRB.

B. Describe Schedule Y guidelines.
C. Explain functions and constitutions of IRB.

SHORT ESSAY - 5 Marks

A. Differentiate between Full board review and Expedited review.

B. Describe Exempt status.

UNIT III - Features of clinical trials- Introduction and understand the various features of clinical trials,
Recent scenario

MCQs - 1 Mark

1. What is meant by randomization?

A. Selection of subjects at random.
B. Randomization is a method of allocating treatment such that each subject has an equal
chance of receiving any of the possible treatments.
 C. Regression to the mean is a common phenomenon in clinical trials.
D. Biases introduce random outcomes.
2. An advantage of randomised controlled trial is
a. Creates a group of people representative of source population
b. Encourages participants to adhere to the study protocol
c. Prevents the bias that arises from research
d. Equally distributes known and unknown confounders
3. Which of the following is a prospective cohort study
a. Relatively cheap and quick to conduct
b. Establishing temporal sequencing
c. Good for rare outcomes that take a long time to develop
d. People are less likely to be lost to follow up
4. What is meant by a blind subject?
a. The subjects do not know which study treatment they receive
b. Patients injected with placebo and active doses
c. Fake treatment
d. Signed document of the recruited patient for the clinical trial procedures
5. Subjects serve as their own controls in which of the following research design?
a. Factorial design
b.Parallel design
C. Cross‐over design
D. Randomized control trial
6.Approximately how many years of research/development/testing does it take to get a drug approved for
marketing?
a. 5
b. 7
c. 12
d. 17
7. On average, how long does it take for the Food and Drug Administration to review data submitted in a
standard New Drug Application (NDA) after the drug has been tested on humans in clinical trials?
a. 6 months
b. 10 months
c. Several weeks
d. An year
8.  Which of the following items are clinical trials designed to test?
a. Drugs/ medications
b. Medical device
c. Vaccines
d. All of the above

9. Where do early phase clinical trials primarily take place?

a. In clinical trial clinics
b. Only in hospital
c. Mostly in clinics some times in hospitals
d. Other

10. Research is
a. Searching again and again
b. Finding solution to any problem
 c. Working in a scientific way to search for truth of any problem
d. None of the above

LONG ESSAY - 10 Marks

A. Discuss the elements of clinical trials.

B. What is informed consent form? Explain its elements in detail.

SHORT ESSAY - 5 Marks

A. Define clinical trial as per code of federal regulation.

B. Who all are involved in clinical trials?
C. Why clinical trials are are performed?

UNIT IV - Outcome measures in clinical research- Introduction and understand the different outcome
measures in clinical research

MCQs - 1 Mark

1.Which outcome consider to be optional?

A. Primary

B. Exploratory

C. Secondary

D. All of the above

2.Which out come used for power of calculation?

A. Primary

B. Secondary

C. Exploratory

D. Tertiary
3. refers to outcomes that are specified AFTER the trial has started.

A.Pre specified outcome measure

B.Post-Hoc Outcome measure

C. A&B Both

D. None of the above

LONG ESSAY - 10 Marks

Describe different outcome measures of clinical trials.

SHORT ESSAY - 5 Marks

A. Discuss surrogate end-point.

B. Explain Quality of life outcome in detail.
C. Describe Economic analysis.

UNIT V - Responsibilities of principle investigators, sponsors and study documents

MCQs - 1 Mark

1. The person responsible for the conduct of the clinical trial at a trial site.
a. Clinical Research Coordinator
b. Monitor
c. Investigator
d. Sponsor
2. Prior to subject’s participation in the trial, the _________________should be signed and
personally dates by the subject or by the subject’s LAR.
a. Protocol
b. Clinical Trial Agreement
c. IRB Approval Report
d. Written Informed Consent Form
3. Whose responsibility is to prepare essential documents like protocol/ investigators
brochure/ informed consent form/ case report form in clinical trials?
a.  Investigator
b. Ethics committee
 c. Scientist
d. Sponsor
4. According to the ICH GCP who is responsible for verifying that storage times and conditions for IMP
are acceptable.
a. The Investigator
b. The Pharmacist
c. The monitor
d. The IRB/IEC
5. According to ICH-GCP how training should be recorded?
a. CVs
b. Training records
c. Certificates
d. There is no specifications
6. Review and follow up of the monitoring report with the sponsor should be documented by the
a. Monitor
b. Project manager
c. Investigator
d. Sponsors designated representatives
7. Who should be responsible for the medical care of trial subject at site?
a. Qualified physician only
b. Investigator
c. Investigator or sub-investigator
d. A qualified physician (dentist when appropriate) who is an Investigator or sub-investigator
8. Responsibility of investigational product of at trial site rests with
a. The designated pharmacist
b. Investigator/institution
c. Investigator or designated pharmacist if applicable
d. Investigator or designated CRC

9. All serious adverse events should be reported immediately to the

a. Sponsor
b. Sponsor and IRB/IEC
c. Sponsor, IRB/IEC and institution
d. Applicable regulatory authority
10. According to ICH GCP WHO CAN BE SUB INVESTIGATOR
a. Associates
b. Residents
c. Research fellow
d. All of the above
LONG ESSAY - 10 Marks

A. Describe the role and responsibilities of principle investigators in clinical trials.

B. Explain the role and responsibilities of sponsors in clinical trials.
C. Enlist the various study documents require for performing clinical trial.

SHORT ESSAY - 5 Marks

A. What is Case record form (CRF)? Explain purpose of it.

B. Enlist the sections of clinical study protocol.

UNIT VI- Monitoring of clinical research

MCQs - 1 Mark

1. What is missing: The sponsor should develop a systematic, prioritized, xxxxxx approach to monitoring
clinical trials.
A.Approved
B. Pragmatic
C. Audited
D. Risk-based
2. What is this: a remote evaluation of accumulating data, performed in a timely manner, supported by
appropriately qualified and trained persons?
A.Data Management
B. Centralised Monitoring
C. Source Data Verification
D. Audit
3. According to ICH GCP (R2) results of monitoring activities should be documented in sufficient detail to
allow verification of what?
A.compliance with the monitoring plan
B. compliance with GCP
C. trial progress
D. compliance with the protocol
4. What are the three main purposed of monitoring?
A. Subject protection, data quality, protocol and GCP compliance
B. Subject protection, management of project milestones, protocol and GCP compliance
C. Data quality, subject recruitment, protocol and GCP compliance
D. Subject protection, data quality, compliance with project timelines
5. According to ICH GCP (R2) who should review and follow up a monitoring report?
 A. The monitor
B. The Project Manager
C. The investigator
D. The sponsor's designated representative
6. According to ICH GCP when, under normal circumstances, should the monitor visit the site?
A. They don’t have to visit
B. Before, during and after the study
C. Every 4-6 weeks
D. At least once
7. Which type of monitoring visit is described here: "To ensure that a potential investigator has the
necessary training, experience and adequate resources to properly conduct the trial"
A.Selection
B. Initiation
C.Monitoring
D.Closeout
8. The monitoring plan should describe the monitoring strategy, the responsibilities, the monitoring
methods to be used, and what else?
A.The rational for the monitoring methods
B. The risks of not following the monitoring plan
C. The qualifications of the monitor
D. The SDV strategy

LONG ESSAY - 10 Marks

A. Define monitoring and explain the purpose of monitoring report.

B. What is the frequency of monitoring requires as per ICH and also what are the parameters on which
frequency depends?

SHORT ESSAY - 5 Marks

A. Describe the stages of monitoring visit.

B. Explain the types of monitoring visit in detail.

UNIT VII- Data Analysis and interpretation

MCQs - 1 Mark

1. Which of the following is the odd one out?

A.Kaplan-Meier

B.Histogram

C.ANOVA

D. Bar

2. What would be being tested for if a Shapiro-Wilk Test was referenced?

 A. Difference in proportions

B. Non-inferiority

C. Normality

D. Correlation

3. If two primary endpoints were referred to as co-primary and the significance level set to 5% which
of the following would be classed as a statistically significant primary endpoint?

A. Primary Endpoint 1: p=0.04, Primary Endpoint 2: p=0.06

B. Primary Endpoint 1: p=0.000001, Primary Endpoint 2: p=0.051

C. Primary Endpoint 1: p=0.06, Primary Endpoint 2: p=0.049

D. Primary Endpoint 1: p=0.049, Primary Endpoint 2: p=0.049

4. If two primary endpoints were referred to as multiple or alternative primary and the significance
level set to 5% which of the following would not be classed as a statistically significant primary
endpoint?

A. Primary Endpoint 1: p=0.04, Primary Endpoint 2: p=0.04

B. Primary Endpoint 1: p=0.00001, Primary Endpoint 2: p=0.06

C. Primary Endpoint 1: p=0.024, Primary Endpoint 2: p=0.001

D. Primary Endpoint 1: p=0.026, Primary Endpoint 2: p=0.024

5. Which of the following is not a method to maintain the type I error level in a clinical trial?

A. Bonferroni

B. Pearson

C. OBrien-Fleming

D. Holm Step Down

6. if the sample size is greater than 2, which of the following would give the smallest value?

A. 1 standard deviation
 B.2 standard deviation

C. 1 standard error

D. 2 standard error

7. Which of the following is NOT true

A. Standard error will reduce with increasing sample size

B. Standard deviation and variability reduce as N gets larger

C. Standard deviation remains reasonably constant as sample size increases

D. If standard deviation increases then so does standard error

8. Which of the following approaches to analysis populations would you expect to be used to analyse
a Phase III Non-inferiority trial?

A. Intention to treat

B. Per Protocol

C. All treated

D. Modified Intention to treat

9. Which of the following is a non-parametric test?

A. ANOVA

B.ANCOVA

C. Wilcoxon Rank Sum Test

D. t-test

LONG ESSAY - 10 Marks

A. Define biostatistics and explain the types of statistics.

B. Classify types of data and explain.

SHORT ESSAY - 5 Marks

A. Define population and sample size.

B. Describe P-value in details.
C. Describe Type-I and Type-II Error.
 D. What is interval estimation? Explain.

UNIT VIII- Reports, publications and critical review

MCQs - 1 Mark

1. According to ICH E3 what report is required for an aborted clinical trial?

A.No report is needed
B. A full report should still be written
C. An abbreviated report may be acceptable
D. This case is not specifically mentioned in ICH E3
2. According to ICH E3 when should the report for a clinical trial be written?
A. As soon as practicable after the end of the trial
B. Within one year of the end of the trial
C. Within one year of database lock
D.ICH E3 does not provide a time frame
3. In ICH E3 which three factors are to be considered under Extent of Exposure?
A. Duration, Dose, Drug Concentration
B. Dose, Drug Concentration, Half Life
C. Dose, Duration, Excretion Rate
D. Duration, Drug Concentration, Half Life
4. In ICH E3 what does TESS stand for?
A. Therapeutic Efficacy and Safety Study
B. Timeline Evaluation of Study Status
C. Trends Emergent in Safety Status
D. Treatment Emergent Signs and Symptoms
5. Which of the following would NOT be considered a protocol deviation under guidance in ICH E3?
A. A subject who developed withdrawal criteria during the study but was not withdrawn
B. A subject who withdrew because of a Serious Adverse Event
C. A subject who received the wrong treatment or incorrect dose
D. A subject who received an excluded concomitant treatment
6. According to ICH GCP who should ensure the accuracy, completeness, legibility, and timeliness of the data
reported to the sponsor in the CRFs and in all required reports.
A. Monitor
B. Study Site Coordinator
C. Investigator
D. Investigational Site
7. According to ICH GCP what should Sponsors have to assure that changes or corrections in CRFs made by
sponsor's designated representatives are documented, are necessary, and are endorsed by the investigator.
A. SOPs
B. Data Handling Manual
C. Written Procedures
D. Working Guidelines
8. According to ICH GCP if correct data reported on the CRF are not consistent with source documents what
should happen?
A. source documents should be changed
B. CRF data should be changed
C. repeat the assessments to create new source data
D. discrepancies should be explained
LONG ESSAY - 10 Marks

A. Discuss the different types of reports require for clinical trial study, explain in detail.

SHORT ESSAY - 5 Marks

A. Why publications of study are necessary? Justify.

B. What do you understand by term critical review? Explain the types and steps of critical review.

UNIT IX- Review, meta-analysis and practice

MCQs - 1 Mark

1. A systematic literature review is:

a. one which generates a literature review using a treasure hunt system.
b. a replicable, scientific, and transparent process.
c. one which gives equal attention to the principal contributors to the area.
d. a manufactured system for generating literature reviews tailored to your subject.
2. Which of the following describes a metaanalyses ?
a. Analyse very large studies
b. Analysis of methods of statistical analysis
c. Establish external validity
d. Detect trends across studies that may have used different procedures, numbers of
participants, types of control procedures and different forms of measurements.

3. What are the advantages of using systematic reviews?

a. Saves the time required to read individual studies
b. Summarizes evidence for a broad range of research methods
c. The results are more reliable than individual studies
d. All of the above
4. Which of the following offers the highest level of evidence when trying to make a decision on a
medicine?
a. Randomised control trial
b. Pharmaceutical company glossy literature
c. Cohort Studies
d. Systematic reviews
5. A published study follows a large group of women with untreated dysplasia of the uterine cervix,
documenting the number who improve, stay unchanged, or progress into cervical cancer. This study
design is best described as which one of the following:
 a. Analytic, experimental
b. Analytic, observational, cohort
c. Analytic, observational, case/control
d. Descriptive, observational
6. Step 4 of systematic review
a. Meta analysis
b. Systematic review
c. Kappa statistic
d. Data analysis
7. Which is NOT a part of the process of doing a meta-analysis?
a. Graphing data from randomized studies to determine whether the intervention had an effect
b. Choosing studies that are appropriate
c. Combining data from all reports to make a single report
d. Graphing data from all included studies to determine whether the intervention had an effect
8. The Forest Plot is (which is NOT TRUE)
a. Shows information from the individual studies of a meta-analysis
b. Allows a visual assessment of the heterogenicity among studies
c. The typical graph for displaying the results of a meta-analysis
d. Found in all review studies
9. What are great advantages of Systematic reviews?
a. Answer on a specific question
b. Include systematically all the relevant articles in the literature
c. Use explicit method
d. All of above

10.Which one of the following has the lowest range of evidence?

a. Rapid Evidence Assessment
b. Quick Scoping Review
c. Narrative Review
d. Systematic Review

LONG ESSAY - 10 Marks

A. Differentiate between systemic review and meta-analysis.

B. Discuss systemic review literature in detail.

SHORT ESSAY - 5 Marks

A. Why are reviews needed? Explain.

B. What are observational studies? Explain in detail.

UNIT X- Review of Literature (MEDLINE, Cochrane collaboration)

MCQs - 1 Mark

1. The principles of The Cochrane Collaboration include?

a. Avoiding duplication and bias
b. Striving for relevance
c. Enabling wide participation and accessibility
d. All of the above

2. Which of the following is not true about e journals ?

a. They are distributed through digital methods
b. They also have editors or editorial boards
c. They are publications of serial nature
d. They are always free of cost

3. Which of the following is not true about e journals ?

a. They are distributed through digital methods

b. They also have editors or editorial boards

c. They are publications of serial nature

d. They are always free of cost

4. Narrative reviews are criticized because they are

a. Not selective in citing reports
b. Based on formal methods
c. Explicit
d. Generally biased

LONG ESSAY - 10 Marks

A. What is a review of literature? Explain.

SHORT ESSAY - 5 Marks

A. Discuss about Medline.

B. Describe the Cochrane collaboration.