ICH Good Clinical Priniciples Part 4

Question 1

Double blind study design entails that the following are unaware of the treatment assignment
a) Subject
b) Investigator
c) Monitor
d) All of the above

Answer 1

Double blind study design entails that the following are unaware of the treatment assignment
d) All of the above

a) Subject
b) Investigator
c) Monitor

Question 2

In a single blind trial the person unaware of the treatment assignment is
a) The subject
b) The investigator
c) The monitor
d) The data analyst

Answer 2

In a single blind trial the person unaware of the treatment assignment is
a) The subject

Question 3

The purpose of a double blind design is to ensure
a) Deceive the subject
b) Reduce the bias on the part of the investigator
c) Reduce the bias on the part of the subject
d) Reduce bias on the part of subject and investigator

Answer 3

The purpose of a double blind design is to ensure
d) Reduce bias on the part of subject and investigator

Question 4

The types of bias on the part of the investigator that are reduced or eliminated by blinding may include
a) Making Changes in the protocol eligibility criteria that may favor the sponsor
b) Data falsification and fabrication
c) Lack of Reporting of protocol deviations and serious adverse events
d) All of the above

Answer 4

The types of bias on the part of the investigator that are reduced or eliminated by blinding may include
d) All of the above

a) Making Changes in the protocol eligibility criteria that may favor the sponsor
b) Data falsification and fabrication
c) Lack of Reporting of protocol deviations and serious adverse events

Question 5

The bias on part of a subject in a clinical trial would best be represented by
a) Complaints to OHRP regarding the IRB
b) Noncompliance with the visitation schedule
c) Altered behavior which may subvert the objective of the trial
d) Non-authorized variation in the drug dosing schedule.

Answer 5

The bias on part of a subject in a clinical trial would best be represented by
c) Altered behavior which may subvert the objective of the trial

Question 6

The term CRO stands for
a) Certified research Organization
b) Certified Research Officer
c) Contract Research Official
d) Contract Research Organization

Answer 6

The term CRO stands for
d) Contract Research Organization

Question 7

Good Clinical Practice represents all of the features below except
a) Is a standard for the design conduct performance of a clinical trial
b) A standard for auditing, recording, monitoring and reporting of a clinical trial
c) Assurance that the data are accurate and credible
e) Assurance that the rights, integrity and confidentiality of trial subjects is protected
f) Represents a mandatory regulatory guidance for clinical trial management

Answer 7

Good Clinical Practice represents all of the features below except
f) Represents a mandatory regulatory guidance for clinical trial management

Question 8

A Data and Safety Monitoring Board does all of the following except
a) Supports SAE review by the IRB
b) Assesses progress of a clinical trial and critical efficacy endpoints
c) Monitors all aspects of data safety for a clinical trial
d) Recommends to the sponsor whether a trial should be continued, modified or stopped

Answer 8

A Data and Safety Monitoring Board does all of the following except
a) Supports SAE review by the IRB

Question 9

An inspection of a clinical trial is all of the following except
a) Usually performed by a regulatory authority
b) Consists of a review of documents, facilities, records and any other resources at the site
c) May occur at the site or at the sponsor or CRO location
d) Is usually integrated into the monitoring schedule.

Answer 9

An inspection of a clinical trial is all of the following except
d) Is usually integrated into the monitoring schedule.

Question 10

An institution (medical) is defined as a site for clinical trials and includes
a) Any public or private entity or agency
b) A medical facility
c) A dental facility
d) All of the above

Answer 10

An institution (medical) is defined as a site for clinical trials and includes
d) All of the above

a) Any public or private entity or agency
b) A medical facility
c) A dental facility

Question 11

An impartial witness is all of the following except
a) A person who cannot be unfairly influenced
b) Attends the informed consent conference when the subject or LAR cannot read
c) Reads any written information supplied to the subject
d) Is usually certified by the institution

Answer 11

An impartial witness is all of the following except
d) Is usually certified by the institution

Question 12

A monitor ensures that a clinical trial is being performed as specified in
a) The protocol
b) Standard operating procedures
c) Good Clinical Practice and other regulatory requirements
d) All of the above

Answer 12

A monitor ensures that a clinical trial is being performed as specified in
d) all of the above

a) The protocol
b) Standard operating procedures
c) Good Clinical Practice and other regulatory requirements

Question 13

A non clinical study is one which is all of the following except
a) Includes all animal studies
b) Any non human study
c) Usually precedes human studies
d) May apply to human studies with high risk and no benefit

Answer 13

A non clinical study is one which is all of the following except
d) May apply to human studies with high risk and no benefit

Question 14

Under ICH GCP all of the following apply to a legally authorized representative (LAR) except:
a) Is an individual authorized to consent on behalf of a trial subject
b) Juridical or other body authorized under applicable law to consent on behalf of a trial subject
c) Often consents in situations where the trial subject is unable to consent for himself because of physical or mental limitations
d) Is authorized to make financial decisions on behalf of the trial subject if hospitalized.

Answer 14

Under ICH GCP all of the following apply to a legally authorized representative (LAR) except:
d) Is authorized to make financial decisions on behalf of the trial subject if hospitalized.

Question 15

Randomization entails all of the following except :
a) Use of a computer generated number system
b) Use of an Interactive Voice recognition System
c) Involves assignments to treatment and control groups
d) Is often decided by a coin toss

Answer 15

Randomization entails all of the following except :
d) Is often decided by a coin toss

Question 16

Under ICH a vulnerable subject may include all of the following except (choose all that apply)
a) Medical pharmacy, dental or nursing students
b) Members of the armed forces
c) Subordinate hospital or laboratory personnel
d) Persons kept in detention
e) Pregnant women
f) Fetuses and neonates
g) Children
h) Unemployed, impoverished or homeless persons
i) Nomads, refugees
j) The elderly
k) Ethnic minority groups
l) Uneducated or illiterate individuals

Answer 16

Under ICH a vulnerable subject may include all of the following except (choose all that apply)
e) Pregnant women
f) Fetuses and neonates
j) The elderly
l) Uneducated or illiterate individuals

Question 17

Central features of a vulnerable subject in ICH GCP include all except
a) Subject influenced by the benefits of participation
b) Subjects influenced by a retaliatory response by a senior member of a hierarchy
c) Subjects of an ethnic minority group
d) Subjects enrolled in more than one clinical trial at the same time

Answer 17

Central features of a vulnerable subject in ICH GCP include all except
d) Subjects enrolled in more than one clinical trial at the same time

Question 18

Responsibility for the investigational product rests with the
a Monitor
b) Sponsor
c) CRO
d) Investigator

Answer 18

Responsibility for the investigational product rests with the
b) Sponsor

Question 19

Regarding the use of the investigational product the investigator should
a) Maintain records that the subjects were provided with the doses stated in the protocol
b) Ensure that the drug was used only as described in the protocol
c) Should ensure that the drug use is explained to the subject and compliance is verified
d) All of the above

Answer 19

Regarding the use of the investigational product the investigator should
d) All of the above

a) Maintain records that the subjects were provided with the doses stated in the protocol
b) Ensure that the drug was used only as described in the protocol
c) Should ensure that the drug use is explained to the subject and compliance is verified

Question 20

If the subject or the LAR is unable to read the informed consent
a) The subject should not be considered for enrollment
b) Written permission should be obtained from the IRB prior to enrollment
c) A family member should be recruited to explain the consent
d) An impartial witness should be present

Answer 20

If the subject or the LAR is unable to read the informed consent
d) An impartial witness should be present

Question 21

The primary role of the witness is to ensure that
a) Provide emotional support to the subject
b) Satisfy the IRB that the informed consent process is adequate
c) Ensure that the information was understood and consent freely given by the subject
d) Verify that signatures and dates on the consent are adequate.

Answer 21

The primary role of the witness is to ensure that
c) Ensure that the information was understood and consent freely given by the subjec

Question 22

The essential documents for a clinical trial should be retained for
a) At least two years after discontinuation of clinical development of the drug
b) For a period of longer than two years if applicable regulatory requirements demand it
c) As long as the sponsor deems it necessary
d) All of the above

Answer 22

The essential documents for a clinical trial should be retained for
d) All of the above

a) At least two years after discontinuation of clinical development of the drug
b) For a period of longer than two years if applicable regulatory requirements demand it
c) As long as the sponsor deems it necessary

Question 23

Premature termination of a clinical trial should be reported by the investigator to
a) The research subjects
b) The regulatory authority if applicable
c) The IRB
d) All of the above

Answer 23

Premature termination of a clinical trial should be reported by the investigator to
d) All of the above

a) The research subjects
b) The regulatory authority if applicable
c) The IRB

Question 24

If the IRB suspends a clinical trial the investigator should report it to
a) The sponsor
b) The institution
c) The regulatory authority
d) Both a and b

Answer 24

If the IRB suspends a clinical trial the investigator should report it to
d) Both a and b

a) The sponsor
b) The institution

Question 25

The final report of the investigator should be provided to
a) The IRB
b) The regulatory authority
c) Both a and b
d) The institution

Answer 25

The final report of the investigator should be provided to
c) Both a and b

a) The IRB
b) The regulatory authority

Question 26

Individuals utilized by the sponsor for all stages of the clinical trial process may include all of the following except
a) Biostatisticians
b) Clinical pharmacologists
c) Physicians
d) Trial subjects where appropriate

Answer 26

Individuals utilized by the sponsor for all stages of the clinical trial process may include all of the following except
d) Trial subjects where appropriate

Question 27

With regard to electronic trial data the sponsor should ensure all of the following except
a) The EDC vendor is approved by the IRB
b) The data changes are documented
c) There is no deletion of entered data
d) An audit, data and edit trials are maintained

Answer 27

With regard to electronic trial data the sponsor should ensure all of the following except
a) The EDC vendor is approved by the IRB

Question 28

For identification of all subject data the sponsor should
a) Use the medical record number
b) Use the name
c) Use an identification code
d) Use a social security number or driver’s license number

Answer 28

For identification of all subject data the sponsor should
c) Use an identification code

Question 29

Before entering an agreement with the investigator/institution the spsnor should provide
a) The IRB with the protocol
b) The investigator/institution with the protocol only
c) The investigator/institution with investigator’s brochure
d) The investigator/institution with protocol and the investigator’s brochure

Answer 29

Before entering an agreement with the investigator/institution the spsnor should provide
d) The investigator/institution with protocol and the investigator’s brochure

Question 30

Delegation of authority to the staff at the site level should be
a) Done independently by the investigator
b) Approved by the IRB
c) Defined established and allocated by the sponsor
d) Delegated to the CRO

Answer 30

Delegation of authority to the staff at the site level should be
c) Defined established and allocated by the sponsor