ICH Questions Part 5

Question 1

With regard to liability claims that may arise against the investigator/institution the sponsor should
a) Provide indemnification
b) Provide insurance where possible
c) Specify compensation for trial subjects in the event of trial related injury
d) All of the above

Answer 1

With regard to liability claims that may arise against the investigator/institution the sponsor should
d) All of the above

a) Provide indemnification
b) Provide insurance where possible
c) Specify compensation for trial subjects in the event of trial related injury

Question 2

The sponsor should ensure that in planning for a clinical trial the sponsor should ensure all of the following except
a) Sufficient safety and efficacy data is available from non clinical studies
b) Pilot studies in human subjects have been performed
c) That the drug will be safe in pregnant women and children
d) Data to support route, dosage and duration of treatment is available.

Answer 2

The sponsor should ensure that in planning for a clinical trial the sponsor should ensure all of the following except
c) That the drug will be safe in pregnant women and children

*should be considered in separate protocols

Question 3

With regard to access to medical records during a clinical trial
a) The subject should consent in writing to medical record access
b) Access should be guaranteed for monitoring, audits, IRB review and regulatory inspection
c) Access should be in accord with prevailing federal and state laws
d) All of the above

Answer 3

With regard to access to medical records during a clinical trial
d) All of the above

a) The subject should consent in writing to medical record access
b) Access should be guaranteed for monitoring, audits, IRB review and regulatory inspection
c) Access should be in accord with prevailing federal and state laws

Question 4

The monitor should ensure all of the following except (check all that apply)
a) Informed consent was obtained before subject participation
b) The investigator receives the investigators brochure
c) Protocol procedures are performed is specified in the protocol’s schedule of assessments
d) Only eligible subjects are enrolled
e) CRFs are accurate and supported by sourced documents
f) Participate in the meetings between the investigator and staff
g) Contribute to the investigator’s recruitment efforts
h) Failed visits, test and procedures not performed are reported on CRFs i Adverse events are reported to the IRB and sponsor in timely fashion

Answer 4

The monitor should ensure all of the following except (check all that apply)
f) Participate in the meetings between the investigator and staff
g) Contribute to the investigator’s recruitment efforts

Question 5

The monitoring report should include
a) Name of the investigator
b) Significant findings, deviations and deficiencies
c) Actions needed to secure compliance
d) All of the above

Answer 5

The monitoring report should include
d) All of the above

a) Name of the investigator
b) Significant findings, deviations and deficiencies
c) Actions needed to secure compliance

Question 6

With regard to access to the sponsors audit report by regulatory authority ICH advises
a) Regulatory authority should not routinely request access to the audit report
b) Require the audit report to be part of he study binder
c) Ask to see the internal audit reports prior to commencing their audits
d) Record the absence of an internal audit report a deficiency

Answer 6

With regard to access to the sponsors audit report by regulatory authority ICH advises
a) Regulatory authority should not routinely request access to the audit report

Question 7

Toxicological effects in the investigator’s brochure should include
a) Carcinogenicity
b) Irritancy
c) Reproductive toxicity
d) Genotoxicity and mutagenicity
e) All of the above

Answer 7

Toxicological effects in the investigator’s brochure should include
e) All of the above

a) Carcinogenicity
b) Irritancy
c) Reproductive toxicity
d) Genotoxicity and mutagenicity

Question 8

The investigator’s brochure should include all of the following except
a) Marketing experience in foreign countries
b) Summary and data Guidance for the investigator
c) Discussion of published reports on related products
d) Potential costs of the clinical trial.

Answer 8

The investigator’s brochure should include all of the following except
d) Potential costs of the clinical trial.

Question 9

Which of the following would not be classified as an SAE?
a) An anaphylactic event which needed an emergency room visit
b) An acute renal failure, which resulted in an increased hospitalization stay of one day
c) A stroke which occurred during a clinical trial
d) Severe hallucinations caused by the ingestion of a recreational drug

Answer 9

Which of the following would not be classified as an SAE?
d) Severe hallucinations caused by the ingestion of a recreational drug

Question 10

In response to new preclinical studies a sponsor revises the Investigator’s Brochure which leads to changes in the inclusion and exclusion criteria and informs the Pl of these changes. The Pl or CRC should
a) File an amendment to the IRB detailing the change
b) Make revisions in the informed consent
c) Reconsent existing enrolled subjects
d) All of the above

Answer 10

In response to new preclinical studies a sponsor revises the Investigator’s Brochure which leads to changes in the inclusion and exclusion criteria and informs the Pl of these changes. The Pl or CRC should
d) All of the above

a) File an amendment to the IRB detailing the change
b) Make revisions in the informed consent
c) Reconsent existing enrolled subjects

Question 11

The person who the subject should contact for research subject rights is
a) The person noted in the consent form for such contact
b) A person other than the principal investigator
c) Usually an IRB appointed Research Subject Advocate described in the consent form
d) All of the above

Answer 11

The person who the subject should contact for research subject rights is
a) The person noted in the consent form for such contact

Question 12

The person who should be contacted regarding a medical emergency experienced at home by a clinical trial subject is
a) Always the principal investigator
b) The sponsor’s medical safety officer
c) The research coordinator
d) The person designated for contact for medical matters on the consent form

Answer 12

The person who should be contacted regarding a medical emergency experienced at home by a clinical trial subject is
d) The person designated for contact for medical matters on the consent form

Question 13

The best way for a Pl to inform a subject about a placebo in a double-blind trial includes all of the following except
a) There is a fifty percent chance that you may be in a group that does not receive the investigational drug
b) Because of the restrictions of the study I cannot tell you if you are in the group receiving drug or a sugar pill
c) You will receive the same attention regardless of whether you are in the group receiving a drug or a sugar pill
d) You need not concern yourself about whether you are receiving the drug or a sugar pill as we cannot tell you if the clinical trial has had any beneficial effect.

Answer 13

The best way for a Pl to inform a subject about a placebo in a double-blind trial includes all of the following except
d) You need not concern yourself about whether you are receiving the drug or a sugar pill as we cannot tell you if the clinical trial has had any beneficial effect.

Question 14

According to ICH all of the following are essential documents except
a) Delegation of authority forms
b) Certificates of analysis for new batches of investigational drugs
c) Normal values for the analytes being tested
d) Conflict of interest information for core team members

Answer 14

According to ICH all of the following are essential documents except
d) Conflict of interest information for core team members

Question 15

A clinical trial in which the only the research pharmacist knows the identity of the test article being given to subjects is a
a) Single-blind trial
b) Double-blind trial
c) Open label trial
d) Crossover design trial

Answer 15

A clinical trial in which the only the research pharmacist knows the identity of the test article being given to subjects is a
b) Double-blind trial

Question 16

A subject on a clinical trial for GI reflux disease experiences several bowel movements and is hospitalized for dehydration. He has been on the test drug for three weeks and the event is thought by the PI to be related to the test drug. The event should be reported in all of the following ways except
a) As a serious adverse event to the IRB
b) To the sponsor on the appropriate CRF
c) By the sponsor to the regulatory agency
d) To the family physician for symptom management

Answer 16

A subject on a clinical trial for GI reflux disease experiences several bowel movements and is hospitalized for dehydration. He has been on the test drug for three weeks and the event is thought by the PI to be related to the test drug. The event should be reported in all of the following ways except
d) To the family physician for symptom management

Question 17

A fatal or life threatening SAE experienced by a subject on a test drug for a clinical trial should be reported to
a) Immediately to the sponsor
b) To the regulatory agency within 7 calendar days
c) To the IRB usually depending on institutional policy
d) All of the above

Answer 17

An SAE experienced by a subject on a test drug for a clinical trial should be reported to
d) All of the above

a) Immediately to the sponsor
b) To the regulatory agency within 7 calendar days
c) To the IRB depending on institutional policy

Question 18

In consenting an adult illiterate subjects who cannot read or write English the consent process should include
a) Reading the consent form to the subject
b) Having the subject make a mark “X” on the subject signature line
c) Have an impartial witness present
d) All of the above

Answer 18

In consenting an adult illiterate subjects who cannot read or write English the consent process should include
d) All of the above

a) Reading the consent form to the subject
b) Having the subject make a mark “X” on the subject signature line
c) Have an impartial witness present

Question 19

About 15 subjects were enrolled in a clinical trial. The trial is most likely
a) Phase l
b) Phase ll
c) Phase III
d) Phase IV

Answer 19

About 15 subjects were enrolled in a clinical trial. The trial is most likely
a) Phase l

Question 20

A clinical trial requires five CT scans in the period of one year. For the disease condition only one CT scan per year is indicated. The situation requires
a) The radiation safety committee evaluation and approval prior to IRB approval
b) Statement about radiation risk in the consent form
c) A consideration of an alternative imaging technique if possible.
d) All of the above

Answer 20

A clinical trial requires five CT scans in the period of one year. For the disease condition only one CT scan per year is indicated. The situation requires
d) All of the above

a) The radiation safety committee evaluation and approval prior to IRB approval
b) Statement about radiation risk in the consent form
c) A consideration of an alternative imaging technique if possible

Question 21

During the course of a clinical trial the CRC notices that the Hct values have been consistently low in several subjects. Upon further investigation it was discovered that the lab assistant was storing the samples under his desk and sending the entire batch for analysis once every week. The CRC should
a) Immediately inform the Pl
b) File a protocol deviation with the IRB
c) Inform the sponsor
d) Arrange to have the lab assistant retrained or disciplined
e) Initiate a CAPA plan
f) All of the above

Answer 21

During the course of a clinical trial the CRC notices that the Hct values have been consistently low in several subjects. Upon further investigation it was discovered that the lab assistant was storing the samples under his desk and sending the entire batch for analysis once every week. The CRC should
f) All of the above

a) Immediately inform the Pl
b) File a protocol deviation with the IRB
c) Inform the sponsor
d) Arrange to have the lab assistant retrained or disciplined
e) Initiate a CAPA plan

Question 22

A CRC has scheduled a first visit for a subject for an IRB approved study. When the patient arrives the CRC notices that the IRB approval letter is missing a date. The CRC should do all of the following except
a) Reschedule the visit
b) Contact the IRB and ask for a dated letter
c) Inform the Pl
d) File an unanticipated event report with the IRB

Answer 22

A CRC has scheduled a first visit for a subject for an IRB approved study. When the patient arrives the CRC notices that the IRB approval letter is missing a date. The CRC should do all of the following except
d) File an unanticipated event report with the IRB

Question 23

A phase I oncology study for lymphoma in children should enroll
a) Healthy adults
b) Healthy children
c) Children with any known cancer
d) Children with lymphoma who have failed standard treatment

Answer 23

A phase I oncology study for lymphoma in children should enroll
d) Children with lymphoma who have failed standard treatment

Question 24

The features of a source document should include their being
a) Attributable and legible
b) Contemporaneous
c) Original and accurate
d) All of the above

Answer 24

The features of a source document should include their being
d) All of the above

a) Attributable and legible
b) Contemporaneous
c) Original and accurate

Question 25

In conducting an audit of source documents the auditor would look for
a) Original entries that were clearly visible, including alterations
b) Traceable or attributable documents
c) An audit trail of access to or alteration of the source documents
d) All of the above

Answer 25

In conducting an audit of source documents the auditor would look for
d) All of the above

a) Original entries that were clearly visible, including alterations
b) Traceable or attributable documents
c) An audit trail of access to or alteration of the source documents

Question 26

Clinical trial records should be preserved for at least
a) Two years post marketing approval
b) Two years post study closure
c) Four years after the filing of marketing application
d) As long as sponsor wants

Answer 26

Clinical trial records should be preserved for at least
a) Two years post marketing approval

Question 27

If a sponsor finds in an audit an action of the investigator which compromises human subject protection or reliability of the trial the sponsor should
a) Immediately terminate the investigator’s involvement
b) Notify the regulatory agency
c) Notify the IRB
d) Conduct a root cause analysis

Answer 27

If a sponsor finds in an audit an action of the investigator which compromises human subject protection or reliability of the trial the sponsor should
d) Conduct a root cause analysis

Question 28

If a potential subject cannot speak or write English and an informed consent conference has to be held, the investigator should
a) Request the appropriate foreign language form from the sponsor
b) Follow IRB procedures, including the use of a consent short form of the foreign language
c) Utilize a qualified and certified interpreter for the communication of the foreign language consent form
d) All of the above

Answer 28

If a potential subject cannot speak or write English and an informed consent conference has to be held, the investigator should
d) All of the above

a) Request the appropriate foreign language form from the sponsor
b) Follow IRB procedures, including the use of a consent short form of the foreign language
c) Utilize a qualified and certified interpreter for the communication of the foreign language consent form

Question 29

A patient with a history of migraines in a clinical trial reports a migraine episode of greater frequency than usuals the investigator should
a) Report the event as an SAE to the IRB
b) Notify the sponsor of an SAE and do so promptly
c) Neither report nor record the event
d) Record and report the episode as an adverse event to the sponsor

Answer 29

A patient with a history of migraines in a clinical trial reports a migraine episode of greater frequency than usuals the investigator should
d) Record and report the episode as an adverse event to the sponsor

Question 30

An SAE is a medical event associated with
a) Death
b) Life threatening event
c) Hospitaization or increased hospitalization stay
d) All of the above

Answer 30

An SAE is a medical event associated with
d) All of the above

a) Death
b) Life threatening event
c) Hospitaization or increased hospitalization stay

Question 31

At a site initiation visit the sponsors CRA reviews
a) The protocol
b) The schedule of assessments and associated CRFs
c) The site’ SOPs
d) All of the above

Answer 31

At a site initiation visit the sponsors CRA reviews
d) All of the above

a) The protocol
b) The schedule of assessments and associated CRFs
c) The site’ SOPs

Question 32

The monitor is responsible for
a) Verifying conflict of interest information on the part of the investigator
b) Facilitating recruitment at the site
c) Assisting the local CRC in scheduling patients
d) Source document verification

Answer 32

The monitor is responsible for
d) Source document verification