Dear Student,

Every student of ICBio has to give an examination before being awarded with the certificate.

Instruction to candidates.
Every student will have to give 4 or 6 modules depending on their course selected
Modules I, II, III are common for students of all courses.
Modules IV, V, VI are specific to your chosen specializations.
Every Paper will have 100 questions each and the time allotted is 1 hour. Each question carries 1 mark
and there is no negative marking. A maximum of 35 marks is required for passing the examination.
This is a model question paper with only 25 questions in each module.

Paper I “Clinical Research and Clinical Pharmacology”

1. Most of drug targets available in human body are:

a. G-PCR
b. Enzymes
c. Ion channels
d. DNA

2. The drug regimen of a drug for particular disease is established in:

a. Phase I trial
b. Phase II trial
c. Phase III trial
d. Phase IV trial

3. One of the primary purposes of a Phase II study is to:

a. The study is complete.
b. Demonstrate long-term safety and efficacy.
c. Gather information on additional indications for the drug.
d. Demonstrate efficacy within the established safe dose range.

4. A sponsor implements the system to maintain the quality of a study by:

a. Source Documents Verification
b. Audits
c. Screening
d. Both (a) and (b)
e. All

5. The form used by investigator for reporting SAE:

a. Form 7442
b. Form 1442
c. Form 1442
d. Form 7443

6. ‘BAD BLOOD’ is the related to one of the following

a. Nazi war crime

Page 1 of 16
b. Japan’s war fare
c. Tuskegee’s study
d. TGN

7. Statement that the study involving research is

a. Primary elements of the ICF
b. Additional elements of the ICF
c. Some time present in the ICF
d. Not related to the ICF
8. When an AE can be considered as SAE?
a. When it results in discontinuation of subject from study
b. When it results in permanent disability
c. When the patient says it is severe
d. When the investigator feels it is severe

9. Tuskegee Study
a. 1932 - 1979
b. 1832 - 1879
c. 1932 - 1973
d. 1932 - 1972

10. Which one of the following document is term as the Blue Print for a study?
a. IB
b. Protocol
c. CRF
d. ICF

11. BA & BE study in Clinical Trial is part of

a. Phase I trial
b. Phase II trial
c. Phase III trial
d. Phase IV trial

12. 1571 is a related to

a. FDA
b. INDA
c. NDA
d. DCGI

13. 21CFR Part-11 is

a. Electronic Records; Electronic Signature
b. Financial Disclosures by Clinical Investigators
c. Investigational New Drug Application
d. Protection of Human Subjects

14. INDA will be submitted after successful completion of

Page 2 of 16
a. Preclinical
b. Phase II
c. Phase III
d. Drug discovery

15. Number of appendixes of Schedule Y

a. 11
b. 12
c. 10
d. 13

16. ICMR stand for

a. Indian Council of Medical Research
b. Indian Council for Medical Research
c. Indian Council on Medical Research
d. Indian Council off Medical Research

17. No. of patients investigator recruited in Public Health Service syphilis study
a. 395
b. 399
c. 499
d. 392

18. OHRP stand for

a. Office for Human Research Protections
b. Office of Human Research Protections
c. Organization for Human Research Protections
d. Organization of Human Research Protections

19. No. of points of the Nuremberg Code

a. 7
b. 9
c. 10
d. 12

20. Following person is conducting actual clinical trial

a. CRC
b. Investigator
c. CRA
d. Sponsor

21. Age is a factor of

a. BA
b. PK
c. Drug efficacy
d. All of above

Page 3 of 16
22. Sixth revision of Declaration of Helsinki was
a. 2006
b. 2008
c. 1998
d. 2002

23. IB is a part of protocol

a. True
b. False
c. Can’t say
d. Invalid Statement

24. CRO is regulated as like

a. Sponsor
b. SMO
c. FDA
d. EC

25. CRA is main communication link between

a. Sponsor & PI
b. Sponsor & EC
c. PI & EC
d. Sponsor & CRO

Paper II, “Ethics, Guidelines and Regulations in Clinical Research”

1. ISO 9004:2000 provides a methodology for continual improvement.

a) True
b) False
c) Neither true nor false
d) None of the above

2. Any research related to human germ line genetic engineering or reproductive cloning is
Prohibited.
a) false
b) true
c) Can not say
d) Question is wrong

3. FDA form 1571 is for

a) IND submission
b) Investigator undertaking
c) Approval from EC
d) ANDA submission

4. One of the following serves for the safety reporting

Page 4 of 16
 a. PSER
b. PSUR
c. SRUF
d. ERFB
5. One of the following has greatest impact on the quality of the data
a. CRF
b. ICF
c. PIS
d. FORM 1572

6. Drug accountability should be done

a. Throughout the study
b. At study close out only
c. Depending on the study
d. Never done
7. An act involving and intentional deviation from the truth or accuracy is
a. Errors
b. Misconduct
c. Fraud
d. All

8. One of the following must be supplied to the investigator before the clinical agreement
a. Protocol synopsis
b. IB
c. IP
d. None
9. Reasons for reporting AEs are
a. The medical monitor under stands the medicinal product better.
b. To satisfy regulatory requirements
c. Investigators responsibility.
d. All of the above
10. Initial SAE report faxed to the sponsor comprises of the following
a. SAE CRF page
b. Notification letter to the sponsor.
c. Notification letter to the chairperson along with the acknowledged receipt form the IRB
d. Notification letter to the FDA

11. During the Investigator Meeting the following are the sponsors’ optional attendees?
a. Biostatistician
b. Preclinical representative
c. Medical monitor
d. Drug development representative
12. One of the following document maintain at the file of the sponsor only
a. Master ICF
b. Master Randomization list
c. Normal value
d. Subject’s Enrolment Log

Page 5 of 16
13. Investigator is not responsible for the following
a. Designing and updating protocol
b. Attending Ethics Committee
c. Submitting documents to DCGI
d. Compensation for trial subjects

14. Which one of the following document is term as the Blue Print for a study?
a. IB
b. Protocol
c. CRF
d. ICF
15. CRC performance is evaluated by the Investigator when
a. Patient recruitment is high
b. Documentation adequate and appropriate
c. Drop out rate < 20
d. Monitor satisfied with the project

16. Financial disclosure document has to be filed and documented by the following personnel?
a. Investigator
b. CRC
c. Investigative Site Manager
d. Monitor

17. Screen fail CRF binders comprises of the following

a. Medical history
b. Investigator signature page
c. Inclusion / Exclusion
d. None of the above

18. One of the following document maintain at the file of the Investigator only
a. Master ICF
b. Master Randomization list
c. Normal value
19. _______________is the process wherein the data collected during the process of trials and reviewed
during the clinical data management is analyzed to decide upon the safety and efficacy parameters of
the drug
a) Data Analysis
b) Subject Analysis
c) Pharmacokinetic Analysis
d)Trial analysis

20. ________________means an environment in which system access is not controlled by persons who
are responsible for the content of electronic records that are on the system.
a) Open system
b) Network
c) Closed System
(d)Biased system

Page 6 of 16
21. _________________ are performed after preliminary evidence suggesting effectiveness of the drug
has been obtained, and are intended to gather the additional information about effectiveness and safety
that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate
basis for physician labeling
a) Phase I
b) Phase II
c) Phase III
d) Phase IV

22. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and
mechanism of action in humans, as well as studies in which investigational drugs are used as research
tools to explore biological phenomena or disease processes.
a)True
(b)False
(c)Can not say
(d)Wrong question
23. Investigator(s) shall report all serious and unexpected adverse events to the Sponsor
a) Within 24 hours
b) Within 7 days
c) Within 14 working days
d) Within 1 month

24. To determine the tolerability of the dose range expected to be needed for later clinical studies and
to determine the nature of adverse reactions that can be expected
a) Phase II
b) Phase I
c) Phase III

25.NIBSC is the Regulatory Authority of Which Country?

a) USA
b) UK
c) Japan
d) Australia

Paper III, “Clinical Trial Management and Quality Management”

1. ______________studies have primary objective of demonstration or confirmation of

therapeutic benefit(s)?
a) Phase III
b) Phase II
c) Phase 0
d) Phase IV

Page 7 of 16
2. Bioequivalence studies should be conducted for comparison of two medicinal products
containing the ____________ substance
a) Same active
b) Different active
c) Single active
d) Opposite active

3. NCE stands for

a) New Clinical Equivalence
b) National Center for Excellence
c) New Chemical Entity
d) New Clinical Experience

4. Essential documents should be retained until at least 2 years after the last approval of a
marketing application in an ICH region and until there are no pending or contemplated
marketing applications in an ICH region or at least 2 years have elapsed.
a) True
(b)False
(c)Can not say
(d)Wrong question

5. A quality system concerned with the organizational process and the conditions, under which
nonclinical health and environmental safety studies are planned, performed, monitored,
recorded, archived and reported.
e) false
f) true
g) Can not say
h) Question is wrong

6. ______________ should be responsible for the integrity, health and welfare of the subjects during the
trial, and the accurate documentation of all trial-related clinical data
a) Clinical research coordinator
b) QA
c) Analyst
d) Medically qualified investigator

7. Criteria for selection of subjects (inclusion and exclusion criteria) and recruitment procedures
should be described in the
a) Clinical trial protocol
b) SOP
c) Contract
d) GCP

8. _______________ refers to the ethical obligation to maximize benefit and to minimize harm
a) Risks
b) Protocol

Page 8 of 16
 c) Beneficence
d) SOP

9. LIMS stands for ________________

a) Laboratory Information Management System
b) Linear integrated Master system
c) Laboratory Integrated management system
d) None of the above

10. All records pertaining to adult stem cell research must be maintaine for at least ____ years
a) 10 years
b) 5 years
c) 15 years
d) 4 years

11. The trial initiation monitoring report should be in

a )Sponsor’s file
b )Investigator’s file
c) None of the above
d) In both (a) and (b)

12. Source documents are present with _______________

a) Investigator
b) Sponsor
c) None of the above
d) DCGI

13. Trial Subject data are

a) CRF
b) Subjects’ visits calendar
c) Efficacy and safety assessment data
d) All of the above

14. SUSAR stands for______________________________

a) Suspected unexpected serious adverse reaction
b) Suspected unwanted Serious adverse reaction
c) Serious Unwanted suspected adverse reaction
d) All of the above

15. HIPAA is the United States Health Insurance Portability and Accountability Act of
a) 1998
b) 2000
c) 1999
d) 1996

16. Any untoward medical occurrence in a patient or clinical investigation subject administered a

Page 9 of 16
 Pharmaceutical product and which does not necessarily have to have a causal relationship
with this treatment.
a) SAE
b) ADR
c) AE
d) SUSAR

17. _______________ trials are those in which participants do not know which group they are in -
and therefore which intervention they are receiving - until the conclusion of the study
a) Double blinded
b) Single-blinded
c) Parallel
d) Cohort study

18. The Belmont Report, published in ______

a) 1979
b) 1964
c) 1947
d) 2007

19. One of the following document maintain at the file of the sponsor only
e. Master ICF
f. Master Randomization list
g. Normal value
h. Subject’s Enrolment Log

20. Subjects’ Visit Schedule is the synonym for the Monitoring visit schedule.
(a)True
(b)False
(c)Can not say
(d)Wrong question

21. The CRO involvement in the monitoring for the clinical trial is specified & approved by the Sponsor
through
a. Protocol
b. IB
c. Clinical Monitoring Plan
d. SAE reporting form

22. CAPA stands for

a) Corrective and Promotive action
b) Confirmative and Preventive Action
c) Corrective and Preventive Action
d) Confirmative and Promotive Action

23. ISO network has its central secretariat at

a) London

Page 10 of 16
 b) New York
c) Geneva
d) Montreal

24. The ISO council meets

a) Once a year
b) Twice a year
c) Thrice a year
d) Four times a year

25. OOS results fall into the categories

a) Laboratory error
b) Non-process related or operator error
c) Process related or manufacturing process error
d) All of the above.

Paper IV, V, VI: CDM, Pharmacovigilance & PRA

1 . Which is the primary database for the Site in EDC?

a) Front-end Database
b) Safety Database
c) Clinical Database
d) Back-end Database

2 . Technique whereby software attempts to read text in a document:-

a) ICF
b) Optical Character Recognition (OCR)
c) Case Report Forms (CRF)
d) None of the above

3 . Techniques for improving and documenting the data transfer process are the use of:-
a) Transfer checklist
b) Transfer metrics
c) Both of the above
d) None of the above

4 . The responsibility to provide feedback and approval in a timely manner during study start up is of:-

Page 11 of 16
 a) CRO
b) CRA
c) CRM
d) Sponsor

5. EDC systems are different from classic CDM:-

a) The central computer storing the data from the trial is typically not the sponsor's computer
b) The central computer storing the data from the trial is typically the sponsor's computer
c) Both of the above
d) None of the above

6 . Some companies call the point at which the last CRF comes in from the site as:-
a) Soft lock
b) Freeze
c) Both of the above
d) None of the above

7. Which of the approaches to data management tasks that can shorten time to study close?
a) Identify missing CRF pages and lab data by knowing what is expected. Use tracking systems
b) Code AEs and medications frequently
c) Enter data as soon as possible after it is received. Data on paper does not move the process
along
d) All of the above

8. Who responsible for implementing and maintaining quality assurance and quality control systems
with written SOPs to ensure that trials are conducted and data is generated, documented (recorded)
and reported in compliance with the protocol, GCP and the applicable regulatory requirement(s)?
a) PI
b) Sponsor
c) CRO
d) CRA

9. Process of creating a design that allows for efficient access and storage is called as:-
a) Short-Fat Database
b) Database Synchronisation
c) Tall-Skinny Database
d) Database Normalisation

10. Users of entry screens where the entry staff looks only at the paper/image and not at the entry fields
or keyboard are called as:-
a) Heads-down
b) Double-pass
c) Single-pass

Page 12 of 16
 d) Heads-up

11 . Select the odd one out from a Change Control can be documented/stored on:-
a) Full database application
b) Paper log
c) Spread sheet
d) Audit trail

12 . The most common mapping challenges during migration are data type mismatches; Code Changes,
Missing Values and:-
a) Migrating key data
b) Migrating data to same platform
c) Unstructured-structured fields
d) Migrating all data

13 . One of the following serves for the safety reporting:-

a) ERFB
b) PSER
c) SRUF
d) PSUR

14 . The Guidelines on Pharmacovigilance for medicinal products for human use is mentioned in:-
a) Volume 8A
b) Volume 9C
c) Volume 9B
d) Volume 9A

15 . As required by legislation the Marketing Authorisation Holder should report within __________
days published serious adverse reactions associated with the use of the active substance(s) of their
medicinal products.
a) 24 hrs
b) 10 days
c) 15 days
d) 30 days

16 .The cut-off date for data to be included in a PSUR is known as:-

a) Data lock point

Page 13 of 16
 b) European birth date
c) Cut-off date
d) None of the above

17 . Clinical Safety Data Management: "Periodic Safety Update Reports for Marketed Drugs" is
mentioned in:-
a) ICH E2C
b) ICH E20
c) ICHE3
d) ICHE1A

18 . Circumstances where less frequent submission of PSUR may be appropriate include:-

a) Product authorised through line-extensions to existing medicinal product
b) Newly authorised generic medicinal product
c) Both of the above
d) None of the above

19 . Which is used for signal detection and its use is recommended in order to retrieve and review cases
of interest where signals are identified from ADR databases?
a) EU-RMP
b) MedDRA
c) SMQs
d) All of the above

20 . The basis for undertaking of pharmacovigilance activities is established in EU legislation, as

described in directive:-
a) 2001/83/EC
b) 2008/83/EC
c) 2001/83/EU
d) None of the above

21. In Agency Crisis Team, ________ has the task for deciding, together with the CHMP Chairperson, to
convene a European crisis Group.
a) The Product Team Leader
b) The Head of Sector Pharmacovigilance
c) The Executive Director
d) None of the above

Page 14 of 16
22. In Agency Crisis Team who has to perform the task for providing all necessary scientific resources:-
a) The Executive Director
b) The Head of Sector Pharmacovigilance
c) The Head of unit Post-authorisation evaluation of medicines for human use
d) The Product Team Leader

23 .Electronic Reporting Guidelines for "Units and measurement controlled vocabulary" is specified in:-
a) ICH-E2A
b) ICH-E2B
c) ICH-M5
d) ICH-E2B(M)

24. "Electronic transmission ofindividual case safety reports message specification" is mentioned in:-
a) ICH-E2A
b) ICH-M5
c) ICH-E2B
d) ICH-M2

25.Periodic ICSRs should be reported to EVPM if they qualify as:-

a. Spontaneous report
b. Report from study
c. Both of the above
d. None of the above

26. Which of the following are parts of a patent?

a. Patent overview
b. Patent summary
c. Patent costing
d. Patent abstract

27. The patent system has received fierce criticism in the past few years because it:

a. All of the above

b. Hinders innovation
c. Favours big and powerful multi-national firms
d. Enables firms to generate abnormally high profits
28. Which of the following cannot be protected by copyright?

Page 15 of 16
 a. Folklore.
b. Literary works.
c. Graphic works.
d. Computer software and hardware

29. In patent law, the invention must have which of the following characteristics?

a. The invention must have unique qualities.

b. The invention must be something new and be invented by the inventor herself.
c. The invention cannot have been in use by others.
d. The invention must be a concrete thing that can be constructed.

30. In which of the following ways can an employer protect him or herself from having trade secrets
disclosed?
a. Disclosure may be prohibited by contract in a restrictive covenant.
b. Disclosure may be prohibited by including a non-disclosure agreement in an employment contract.
c. Disclosure may be prohibited by marking copies of information confidential.
d. 1 and 2 above.

Page 16 of 16