ICH Questions Part 1

Question 1

In ICH-GCP an audit is defined as
a) A systematic and independent examination of trial related activities and documents
b) An investigation intended to discover and verify the clinical effects of an investigational product
c) Official review of documents facilities records and any other resources
d) Overseeing of the progress of a clinical trial

Answer 1

In ICH-GCP an audit is defined as
a) A systematic and independent examination of trial related activities and documents.

Question 2

In ICH-GCP an inspection is defined as
a) A systematic and independent examination of trial related activities and documents
b) An investigation intended to discover and verify the clinical effects of an investigational product
c) Official review of documents, facilities, records and any other resources
d) Overseeing of the progress of a clinical trial

Answer 2

In ICH-GCP an inspection is defined as
c) Official review of documents, facilities, records and any other resources

Question 3

In ICH-GCP monitoring is defined as
a) A systematic and independent examination of trial related activities and documents
b) An investigation intended to discover and verify the clinical effects of an investigational product
c) Official review of documents, facilities, records and any other resources
d) Overseeing of the progress of a clinical trial

Answer 3

In ICH-GCP monitoring is defined as
d) Overseeing of the progress of a clinical trial

Question 4

In ICH-GCP a clinical trial is defined as
a) A systematic and independent examination of trial related activities and documents
b) An investigation intended to discover and verify the clinical effects of an investigational product
c) Official review of documents, facilities, records and any other resources
d) Overseeing of the progress of a clinical trial

Answer 4

In ICH-GCP a clinical trial is defined as
b) An investigation intended to discover and verify the clinical effects of an investigational product

Question 5

In ICH-GCP an investigator is defined as
a) A person responsible for the conduct of the clinical trial
b) An individual supervised by the team leader
c) A person responsible for initiation, management and financing of a clinical trial
d) A person responsible for overseeing the progress of a clinical trial

Answer 5

In ICH-GCP an investigator is defined as
a) A person responsible for the conduct of the clinical trial

Question 6

In ICH-GCP a sponsor is defined as:
a) A person responsible for the conduct of the clinical trial
b) An individual supervised by the team leader
c) A person/entity responsible for initiation, management and financing of a clinical trial.
d) A person/ entity responsible for overseeing the progress of a clinical trial

Answer 6

In ICH-GCP a sponsor is defined as:
c) A person/entity responsible for initiation, management and financing of a clinical trial.

Question 7

In ICH-GCP a monitor is defined as:
a) A person responsible for the conduct of the clinical trial
b) An individual supervised by the team leader
c) A person/entity responsible for initiation, management and financing of a clinical trial
d) A person responsible for overseeing the progress of a clinical trial

Answer 7

In ICH-GCP a monitor is defined as:
d) A person responsible for overseeing the progress of a clinical trial

Question 8

In ICH-GCP a sub-investigator is defined as:
a) A person responsible for the conduct of the clinical trial
b) An individual supervised by the team leader
c) A person/entity responsible for initiation, management and financing of a clinical trial.
d) A person responsible for overseeing the progress of a clinical trial

Answer 8

In ICH-GCP a sub-investigator is defined as:
b) An individual supervised by the team leader

Question 9

In ICH-GCP a co-investigator is defined as
a) A person responsible for overseeing the progress of a clinical trial
b) An individual supervised by the team leader
c) A person responsible for assuming, when needed, the responsibilities of an investigator/team leader
d) A person responsible for funding the clinical trial.

Answer 9

In ICH-GCP a co-investigator is defined as
c) A person responsible for assuming, when needed, the responsibilities of an investigator/team leader.

Question 10

In ICH-GCP quality assurance is defined as
a) Planned and systematic action to ensure that the data is generated recorded and reported according to GCP
b) The act of overseeing the progress of a clinical trial
c) The act of performing inspections of a clinical trial
d) The act of performing an official review of a clinical trial

Answer 10

In ICH-GCP quality assurance is defined as
a) Planned and systematic action to ensure that the data is generated recorded and reported according to GCP.

Question 11

ICH-GCP requires that a regulatory authority be given direct access to a clinical trial records. Direct access includes the ability to do all except
a) Examine and analyze all clinical trial records
b) Verify the clinical trial records
c) Reproduce any records as needed
d) Not assume responsibility during an audit for the confidentiality of the clinical trial records.

Answer 11

ICH-GCP requires that a regulatory authority be given direct access to a clinical trial records. Direct access includes the ability to do all except
d) Not assume responsibility during an audit for the confidentiality of the clinical trial records.

Question 12

Source documents in a clinical trial refer to all except
a) Medical notes and pertinent parts of a medical record
b) Laboratory and radiology findings
c) Pathology reports
d) Patient diaries and pharmacy records
e) Site monitoring reports

Answer 12

Source documents in a clinical trial refer to all except
e) Site monitoring reports

Question 13

The ethical framework cited in ICH-GCP as the framework for conducting clinical trials is
a) Declaration of Helsinki
b) Belmont report
c) Nuremberg Code
d) CIOMS guidelines

Answer 13

The ethical framework cited in ICH-GCP as the framework for conducting clinical trials is
a) Declaration of Helsinki

Question 14

Which of the following statements about risk in clinical trials does not apply to ICH-GCP?
a) Foreseeable risk should be weighed against anticipated benefit
b) Anticipated benefit should justify the risk
c) The well-being of the subject should prevail over the interests of science and society
d) The importance of the objective may in certain circumstances outweigh the risk to the subject

Answer 14

Which of the following statements about risk in clinical trials does not apply to ICH-GCP?
d) The importance of the objective may in certain circumstances outweigh the risk to the subject

Question 15

Regarding informed consent in clinical trials ICH states that
a) Waivers of informed consent are possible
b) Waiver of documentation of informed consent may be given
c) Informed consent should be obtained from every subject
d) Parental permission should be given only when it is a reasonable protection

Answer 15

Regarding informed consent in clinical trials ICH states that
c) Informed consent should be obtained from every subject.

Question 16

Regarding the protection of privacy and confidentiality, ICH:
a) States that specific guidelines be followed for the protection of confidentiality
b) Affirms the principles of HIPAA in privacy and confidentiality
c) Does not mention privacy and confidentiality explicitly in its guidelines
d) Affirms that privacy and confidentiality be protected in accordance with applicable regulatory requirements

Answer 16

Regarding the protection of privacy and confidentiality, ICH:
d) Affirms that privacy and confidentiality be protected in accordance with applicable regulatory requirements

Question 17

With regard to quality assurance in clinical trials ICH affirms of all of the following except
a) States that systems with procedures that assure quality be implemented for every aspect of the clinical trial
b) The sponsor is responsible for implementing and maintain quality assurance and quality control with written SOPs
c) Quality control be applied to every stage of data handling
d) The IRB should review the quality control measures of a clinical trial.

Answer 17

With regard to quality assurance in clinical trials ICH affirms of all of the following except
d) The IRB should review the quality control measures of a clinical trial.

Question 18

Agreements between the sponsor and the investigator:
a) Should be In writing as part of the protocol or in a separate agreement
b) May be verbally implemented
c) Must be provided to the IRB prior to study approval
d) May be signed by the CRO on behalf of the sponsor

Answer 18

Agreements between the sponsor and the investigator:
a) Should be In writing as part of the protocol or in a separate agreement.

Question 19

According to ICH, the IRB should obtain the following documents from the investigator
a) Protocol, consent, recruitment procedures, investigator’s brochure, payments
b) Protocol, consent, case report forms, payments, CV
c) Protocol, consent, monitoring plan, payments, CV, recruitment
d) Protocol, monitoring plan, investigator’s brochure, payments, CV

Answer 19

According to ICH the IRB should obtain the following documents from the investigator
a) Protocol, consent, recruitment procedures, investigator’s brochure, payments.

Question 20

According to ICH, the copy of the CV given to the IRB should be
a) No more than a year old
b) No more than two years old
c) No date on the CV is required
d) Current

Answer 20

According to ICH the copy of the CV given to the IRB should be
d) Current

Question 21

With regard to payments to subjects ICH indicates that
a) Payments be free of coercion and undue influence
b) Payments should be prorated
c) Methods, amounts and schedule of payments be set forth in the informed consent.
d) All of the above.

Answer 21

With regard to payments to subjects ICH indicates that
d) All of the above.

Question 22

With regard to a quorum for the IRB ICH specifies that
a) It is majority of members
b) It is more than 50% of the roster
c) It is governed by a specified formula
d) It should be stipulated in the written procedures

Answer 22

With regard to a quorum for the IRB ICH specifies that
d) It should be stipulated in the written procedures