1. Audit of a Trial means

A systematic verification of the study, carried out by persons directly involved in the study.

A systematic verification of the study, carried out by persons not directly involved in the study.

A random verification of the study, carried out by the financial department.

A systematic verification of the study, carried out by the financial department.

2. Double blind trial refers to

The study "subject(s) and/or investigator(s) "is/are unaware of the assigned but monitor and data analyst(s) are aware of the treatment assigned.

The study subject(s) and/or investigator(s), monitor being unaware of the treatment assigned, but data analyst(s) are aware of the treatment assigned.

The study subject(s) and/or investigator(s), monitor and data analyst(s) are unaware of the treatment assigned.

The study subject(s) and/or investigator(s), and data analyst(s) being unaware of the treatment·assigned, monitors are aware of the treatment·assigned.

3. The objective of Phase-I of trials is to determine

the maximum tolerated dose in humans; pharmacodynamic effect and adverse effects

the maximum tolerated dose in animals; pharmacodynamic effect and adverse effects

the minimum tolerated dose in humans; pharmacodynamic effect and adverse effects

the maximum tolerated dose in humans; and pharmacodynamic effect

4. The selection of clinicians for monitoring and supply of drug to them

will need approval of the Ethics Committee

will need approval of the CRO

will need approval of the institutional head .

will need approval of the licensing authority

5. Principles of essentiality means

Research is necessary for the advancement of knowledge and for the benefit of all members of the human species and for the ecological and environmental well-being of the planet.

Research is necessary for the advancement of knowledge and for the benefit of all members of the scientific community and for the ecological and environmental well-being of the planet.

Research is necessary for the advancement of knowledge and for the benefit of members of the developed countries and for the ecological and environmental well-being of the planet.

Research is necessary for the advancement of knowledge and for the benefit of all members of the developing countries and for the ecological and environmental well-being of the planet.

6. Principles of totality of responsibility have to be followed by

The researchers

The funding agencies

The institution where research is being conducted

All the persons and agencies involved in research

7. The minimum number of persons required Committee is to compose a quorum of an Ethics

3

5

7

9

8. The Chairperson of the Ethics Committee should preferably

Be the head of the institution

Be a representative of the institution

Be from outside of the institution

Be from outside of the institution with a legal background

9. In case of a Non-Therapeutic Study, the consent

Must always be given by the subject

Is not requited

Can be given by the institution on behalf of the subject

May be given by the legal representative

10. In case of severe adverse event, the Ethics Committee should inform the licensing authority about the event and the action is to be taken within

30 days

60 days

90 days

120 days

11. A subject who suffers from an injury during clinical trial

Should be given free treatment for life

Should be given free treatment till the condition resolves

Should be given free treatment only if the injury is a result of clinical trial

Should not be given free treatment as the patient willingly agrees for the trial knowing the risks·and benefits

12. Abbreviated drug trials are allowed in the following situation:

Generics and biological approved in other countries as soon as the approval is obtained

Generics and biological approved in other countries are never allowed in our country .

For new drugs that are vital to the country

Generics and biological that have been in use for more than 4 years in other countries

13. Compensation to a trial participant should be paid

For any injury that occurs during the time of trial

For any injury that occurs after the trial has ended, if the injury is caused by the participation in the trial

Only for death that occurs after the trial has ended, if the death is caused by the participation in the trial

Only for death that occurs during the trial

14. Compensation for death is based on

Motor Vehicle Accident Act

ESI Act

Workmen's Compensation Act

The Companies Act

15. The first ethics guideline was issued by ICMR in the year

1970

1980

1990

2000

16. The guideline to be followed for animal experimentation is

The Indian National Science Academy (INSA) guidelines

ICMR guidelines

PETA guidelines

SPCA guidelines

17. ICH GCP Guideline is to provide a unified standard for the following regions:

All countries doing drug trials

European Union Japan and the United States

Developing countries

The United States and Canada only

18. New drug that is being introduced should be approved by

Institutional Ethics Committee

DCGI

DCGI and Institutional Ethics Committee t

DCGI, Government ofIndia and Institutional Ethics Committee

19. More than minimal manipulation of stem cells is

No major alterations in cell population or function

Defined as alterations in cell population, which is expected to result In alteration of function

Long-term culture of cells through multiple passages

Induction of genetic alteration by insertion of gene/siRNA

20. All these researches are prohibited except

Studies on chimeras

Human germ line genetic engineering

Reproductive cloning

Implantation of human embryo into uterus after in-vitro manipulation, at any stage of development, in humans or primates

21. In a living related donor, all these ethical principles are fulfilled except

Autonomy

Beneficence

Non-malfeasance

Justice

22. Embryonic stem cells are derived from

Spare blastocysts

The inner cell mass(ICM) of blastocysts

Genetic reprogramming of somatic cells

Hematopoietic stem cells

28. Data Safety Monitoring Board (DSMB) for stem cell research

Shall comprise members associated with IC-SCRlNAC-SCR

Shall comprise independent members not associated with IC-SCRlNAC-SCR

Shall be constituted by IC-SCRlNAC-SCR

Shall be constituted by the institution irrespective of funding

24. Cord Blood Stem Cell Banking

Requires registration and license from the DCGI

Does not require any license

Requires license from the local body

Requires license from the State Health Department

25. All these are ethical issues involved in the use of stored umbilical cord blood except

Concern about ownership

Risk of transmission of potential genetic disorders

Autonomy

Justice

26. The following is true in case of termination of pregnancy for formation of stem cells

It is banned.

It can be done for financial gain.

The donor cannot specify the use of the foetal tissue.

The person doing the abortion and the person using the foetal tissue must be same.

27. The following is true about the consent for donation of supernumerary embryos after clinical care

Consent should be obtained 48 hours before the actual donation

Once the consent is given it cannot be withdrawn

The donor has the right to withdraw the consent :until the blastocysts are actually used in cell line derivation

Consent should be obtained just before the embryo is used for forming embryonic stem cells

28. The benefits of the commercial returns from the products of stem cell should be shared with the

Institution obtaining the tissue

Government

Donor of the embryo even if it is not mentioned in the consent form

Community

29. Exemption from review is granted

To research on educational practices

To research strategies that involve public behaviour and can identify the human participant directly

When interviews involve direct approach or access to pHvate papers

In emergency situations

30. A. physician may' use new intervention as investigational intervention to provide emergency medical care to his/her patients in life threatening conditions except

When the consent of patient/responsible relative is not possible to obtain

When the intervention has undergone testing for safety prior to its use in emergency situations and there is prior approval of DCGI

When the local IEC reviews the protocol and approves it before emergency

When there is no Data Safety Monitoring Board to access the effectiveness of the treatment

31. All of these are essential for research on disaster management except

Research planned to be conducted after a disaster should be essentially culturally sensitive and specific in nature with possible application in future disaster situations.

Disaster-affected community participation is not essential and its representative or advocate must be identified.

Extra care must be taken to protect the privacy and confidentiality of participants and communities.

Protection must be ensured so that only minimal additional risk is imposed.

32. The amount of blood that is permitted to be drawn by ICMR from healthy adults and non-pregnant women who weigh normal for their age is

Not more than 500 ml blood drawn in an 8-week period and the frequency of collection is not more than 2 times per week

Not more than 500 ml blood drawn in a 4-week period and the frequency of collection is not more than 3 times per week

Not more than 300 ml blood drawn in an 8-week period and the frequency of collection is not more than 2 times per week

Not more than 800 ml blood drawn in an 8-week period>and ·the frequency of collection is not more than 2 times per week

33. In all these Conditions fresh consent or re-consent is taken except

When a research participant regains consciousness from unconscious state

When long-term follow-up or study extension is,planned later

On availability of new information which would necessitate deviation of protocol

On availability of new information which does not necessitate deviation of protocol

34. Waiver of the requirement for informed consent can be granted in all these conditions except

When it is impractical to conduct research

When the research is on publicly available information

When the research is on anonymized biological samples

In emergency situations when no surrogate consents can be taken

35. Conflict of interest is

A set of conditions in which professional judgement concerning a primary interest such as the validity of research tends to be unduly influenced by financial gain.

A set of conditions in which professional judgement concerning a primary interest such as the validity of research tends to be or appears to be unduly influenced by a secondary personal interest.

A set of conditions in which professional judgement concerning a primary interest such as the validity of research tends to be or appears to be unduly influenced by a secondary interest or financial gain.

A set of conditions in which professional judgement concerning a primary interest such as the validity of research tends to be or appears to be unduly influenced by a need to achieve academic success.

36. Prenatal Diagnostic Techniques Act, allows for

Sex determination

Identification of genetic disorders

Abortions when foetal anomalies are discovered late in the course of pregnancy

Sex selective abortions

37. Research must be done on

People who are poor so that the rich can benefit

Mentally challenged persons so that the normal people can benefit

Rich and poor people so that all can benefit

Rich so that the poor can benefit

38. In the post study period, one of the following is true:

Sponsor must make arrangements for free drugs to the participants that they received during the study, throughout their life.

Sponsor must make arrangements for the access of the drug to the subjects till the drug is available in the market.

Sponsor must riot take any responsibility for post trial access to the drugs found beneficial in the study.

Sponsor may take a decision on post trial access to the medicine after completion of the study.

39. Standard of care for a clinical trial is the

Best available care known to the scientific community

Best available care in the local institution

Best available care that the researcher can give

Best available care that is available nationally

40. Misconduct in research means all these except

Reporting data on adverse effect

Fabrication

Falsification

Plagiarism

41. For new drug substances discovered in India

Phase-1 clinical trial is not essential for marketing the drug

Phase-1 and Phase-2 clinical trials are enoughJor marketing the drug

Phase-1, Phase-2 and Phase-3 clinical trials are a must for marketing the drug

Phase-1, Phase-2, Phase-3 and Phase-4 of the clinical trials are required before the drug can be marketed in India

42. Bioequivalence studies are necessary

For all new drug substances and for new dosage forms administered for systemic absorption which are approved elsewhere in the world.

Only for new drug substances forms administered for systemic absorption which are approved elsewhere in the world.

Only for new dosage forms administered for systemic absorption which are approved elsewhere in the world.

For all new drug substances and for new dosage forms administered for systemic absorption which are to be approved in our country.

43. . Active Control Equivalence trial is

A non-inferiority trial

A superiority trial

A trial in which placebo can be used

Not indicated

44. Efficacy in vaccine trials means

Information of protective rate conferred on a given population.

It measures the direct and indirect protection to a non-vaccinated person among the defined vaccinated population determined by the vaccine.

It is the correlation between the strains present in the vaccine and that circulating in the area.

Reduction in incidence of the disease after vaccination compared to the incidence that prevailed before vaccination.

45. Bridging studies in vaccine trials are done

When there is a change in vaccine composition

When the vaccine is suspected to be ineffective

Comparing only the sera

Only to show the immunogenicity of the new product

46. Post trial access to the vaccine should be given first

To the family of the individual who participated in the study.

To the community from which the participants were drawn.

To all the persons who are at a high risk from the disease that the vaccine protects.

To the person who can afford to pay for the vaccine.

47. The organisation that certifies and regulates low technology devices in India is

The Drugs Controller General of India (DCGI)

India Standards Institute

The Bureau of Indian standards

The Federal Drug Administration of the United States ofAmerica

48. Category I drug trials are conducted for the following class ofAUS drugs:

Substances that have never been in use before

Has not ever.been mentioned in ancient literature

Clinically evaluated for a therapeutic effect not originally described in the texts of traditional systems

The substance to be tested is already in use in Indian Systems of Medicine or has been described in their texts

49. In a drug trial conducted on Unani medicine by an allopathic doctor or institution

It is necessary to have a Unani practitioner as a co-investigator

A practitioner of an alternate system of medicine can be a co-investigator

There is no need for a co-investigator

The investigator can incorporate another allopathic doctor trained in Unani and is not registered

50. In an epidemiological study, the consent has to be obtained

Only from the individual

Only from the community

Only from the family

Only from the individual and the community