ICH Good Clinical Priniciples Part 3

Question 1

Regarding withdrawals or drop outs among study subjects, ICH recommends that
a) They be reported to the IRB.
b) They be recorded and explained on the appropriate CRFs
c) Notifications be sent to the regulatory authorities
d) Notification be sent to the institution.

Answer 1

Regarding withdrawals or drop outs among study subjects, ICH recommends that
b) They be recorded and explained on the appropriate CRFs.

Question 2

ICH guidelines for trial design in protocol preparation includes all except
a) Description of the designs (double-blind, placebo, parallel design)
b) Randomization and blinding
c) Dosage regimens
d) Stopping rules
e) Data recorded directly without source documents
f) IRB communication guidelines

Answer 2

ICH guidelines for trial design in protocol preparation includes all except
f) IRB communication guidelines

Question 3

ICH guidelines for protocol preparation in clinical trials includes all except:
a) Inclusion and exclusion criteria
b) Withdrawal and replacement of subjects
c) Schedule of assessments
d) Assessments of safety and efficacy
e)Statistical analysis
f) Publication policy
g) Conflict of interest disclosure

Answer 3

ICH guidelines for protocol preparation in clinical trials includes all except:
g) Conflict of interest disclosure

Question 4

According to ICH statistical analysis section of the protocol should specify whether the following subjects will be included in the analysis except
a) All randomized subjects
b) All dosed subjects
c) All evaluable subjects
d) All eligible subjects
e) All screened subjects

Answer 4

According to ICH statistical analysis section of the protocol should specify whether the following subjects will be included in the analysis except
e) All screened subjects

Question 5

According to ICH the statistical analysis section of the protocol should include
a) Sample size and power calculations
b) Description of the statistical methods to be used
c) Level of significance for hypothesis testing
d) Criteria for termination of the trial
e) All of the above

Answer 5

According to ICH the statistical analysis section of the protocol should include
e) All of the above

a) Sample size and power calculations
b) Description of the statistical methods to be used
c) Level of significance for hypothesis testing
d) Criteria for termination of the trial

Question 6

Description of the investigator’s brochure is included in
a) DHHS regulations
b) ICH
c) FDA regulations and guidance
d) OHRP regulations and guidance

Answer 6

Description of the investigator’s brochure is included in
b) ICH

Question 7

According to ICH the investigator’s brochure should include
a) Physical, chemical and pharmaceutical properties and formulations
b) Nonclinical studies including nonclinical pharmacology
c) Pharmacokinetics and toxicology
d) Effects in humans
e) Summary of data and guidance for the investigator
f) All of the above

Answer 7

According to ICH the investigator’s brochure should include
f) All of the above

a) Physical, chemical and pharmaceutical properties and formulations
b) Nonclinical studies including nonclinical pharmacology
c) Pharmacokinetics and toxicology
d) Effects in humans
e) Summary of data and guidance for the investigator

Question 8

The investigator brochure is a living document that is continually updated in a clinical trial to include
a) The latest nonclinical studies
b) Changes in chemistry of the product
c) The latest results from completed clinical trials
d) All of the above

Answer 8

The investigator brochure is a living document that is continually updated in a clinical trial to include
d) All of the above

a) The latest nonclinical studies
b) Changes in chemistry of the product
c) The latest results from completed clinical trials

Question 9

According to ICH the essential documents to be placed on file before the start of a clinical trial include all of the following except
a) Investigator’s brochure
b) Protocol and other sponsor/ CRO agreements
c) Informed consents
d) Recruiting and advertising information
e) Financial aspects and insurance information
f) IRB approvals
g) CV for investigator and sub investigator
h) Randomization and decoding information
f) Site initiation report and pre-trial site suitability assessments
j) Forms 1571 and 1572

Answer 9

According to ICH the essential documents to be placed on file before the start of a clinical trial include all of the following except
j) Forms 1571 and 1572

Question 10

According to ICH, the additional documents to be placed on file during a clinical trial include
a) Enrollment and screening logs
b) Annual reports to the IRB
c) Signature sheet/delegation log
d) Drug accountability records
e) All of the above

Answer 10

According to ICH, the additional documents to be placed on file during a clinical trial include
e) All of the above

a) Enrollment and screening logs
b) Annual reports to the IRB
c) Signature sheet/delegation log
d) Drug accountability records

Question 11

According to ICH the additional documents to be included on file after completion of the trial are
a) Final close out study monitoring report
b) Final report to IRB
c) Clinical study report to document results and interpretation of trial
d) All of the above

Answer 11

According to ICH the additional documents to be included on file after completion of the trial are
d) All of the above

a) Final close out study monitoring report
b) Final report to IRB
c) Clinical study report to document results and interpretation of trial

Question 12

According to ICH, the following statements about the involvement of a CRO in a clinical trial are correct:
a) A sponsor may transfer any or all of the trial related duties and functions to a CRO
b) The CRO should implement quality assurance and quality control
c) The delegated CRO responsibilities should be specified in writing
d) All of the above

Answer 12

According to ICH the following statements about the involvement of a CRO in a clinical trial are correct:
d) All of the above

a) A sponsor may transfer any or all of the trial related duties and functions to a CRO
b) The CRO should implement quality assurance and quality control
c) The delegated CRO responsibilities should be specified in writing

Question 13

It would be usual practice for a CRO to assume all of the responsibilities outlined below except
a) Collection of forms 1572 form the PI
b) Preparation and distribution of the regulatory binder
c) Site initiation and site close out visits
d) Monitoring data integrity and quality e)
Reviewing the delegation of authority log
f) Pretrial investigator and facilities assessment
g) Preparation of the investigator’s brochure and the updates
h) Distribution of the protocol and protocol updates.

Answer 13

It would be usual practice for a CRO to assume all of the responsibilities outlined below except
g) Preparation of the investigator’s brochure and the updates.

Question 14

It would be usual practice for a CRO to assume all of the responsibilities outlined below except
a) Implementation of randomization schema
b) Review of all regulatory aspects pertaining to the laboratory
c) Review of all regulatory aspects of drug accountability
d) Implementing and monitoring payments to subjects.
e) Collection of SAE reports and forwarding to sponsor
f) Protocol preparation and DSMB management

Answer 14

It would be usual practice for a CRO to assume all of the responsibilities outlined below except
f) Protocol preparation and DSMB management

Question 15

The Medical Safety Officer at the sponsor carries out which of the duties listed below?
a) Providing medical advice during the clinical trial
b) Assessing medical waivers of eligibility
c) Review of SAEs and continuance of subjects on the study
d) All of the above.

Answer 15

The Medical Safety Officer at the sponsor carries out which of the duties listed below?
d) All of the above

a) Providing medical advice during the clinical trial
b) Assessing medical waivers of eligibility
c) Review of SAEs and continuance of subjects on the study

Question 16

Which of the duties listed below are typically carried out by the sponsor and not the CRO?
a) Protocol preparation and updates
b) Investigator brochure preparation and updates
c) Correspondence and interaction with the FDA
d) Manufacture and supply of investigational drug
e) Preparation of the pharmacy manual
f) Management of the DSMB
g) All of the above

Answer 16

Which of the duties listed below are typically carried out by the sponsor and not the CRO?
g) All of the above

a) Protocol preparation and updates
b) Investigator brochure preparation and updates
c) Correspondence and interaction with the FDA
d) Manufacture and supply of investigational drug
e) Preparation of the pharmacy manual
f) Management of the DSMB

Question 17

If the investigator terminates a trial at the site without prior approval from the sponsor he should inform the following in writing of this decision
a) IRB
b) Institution
c) Sponsor
d) All of the above

Answer 17

If the investigator terminates a trial at the site without prior approval from the sponsor he should inform the following in writing of this decision
d) All of the above

a) IRB
b) Institution
c) Sponsor

Question 18

Regarding the issuance of a final report by the investigator, the ICH advises that the investigator should
a) Inform the institution
b) Provide the IRB with a summary of the trial’s outcome
c) Provide regulatory authorities with any reports that may be required, if applicable.
d) All of the above

Answer 18

Regarding the issuance of a final report by the investigator the ICH advises that the investigator should
d) All of the above

a) Inform the institution
b) Provide the IRB with a summary of the trial’s outcome
c) Provide regulatory authorities with any reports that may be required, if applicable.

Question 19

According to ICH, for an investigator to be eligibie to conduct a clinical trial he should be
a) Qualified by education, training and experience
b) Meet the qualification specified by regulatory authorities and the IRB
c) Should provide documentary evidence of his qualifications to the sponsor and the IRB
d) All of the above

Answer 19

According to ICH, for an investigator to be eligibie to conduct a clinical trial he should be
d) All of the above

a) Qualified by education, training and experience
b) Meet the qualification specified by regulatory authorities and the IRB
c) Should provide documentary evidence of his qualifications to the sponsor and the IRB

Question 20

ICH advises that the following individuals may be utilized in trial design except
a) Biostatisticians
b) Clinical pharmacologists
c) Physicians
d) Financial analysts

Answer 20

ICH advises that the following individuals may be utilized in trial design except
d) Financial analysts

Question 21

ICH advises that in terms of compensation for claims arising during a clinical trial the sponsor should
a) Not provide any assurances to the site
b) Assume negligence on the part of the PI
c) Provide insurance or indemnify the investigator
d) Compensate only life threatening emergencies on the part of the subject.

Answer 21

ICH advises that in terms of compensation for claims arising during a clinical trial the sponsor should
c) Provide insurance or indemnify the investigator

Question 22

Regarding the monitor’s reports ICH advises that they include all of the following except
a) They be in written form, dated and signed
b) Include a summary of what was reviewed, deviations and deficiencies and actions to be taken
c) Review and follow up of the report with the sponsor
d) Punitive actions to be taken against the Pl or study coordinator

Answer 22

Regarding the monitor’s reports ICH advises that they include all of the following except
d) Punitive actions to be taken against the Pl or study coordinator

Question 23

Regarding the sponsor’s audits of a clinical trial ICH advises all of the following except
a) Written procedures to be followed in the event of an audit
b) The audit plan takes into account the complexity and importance of the clinical trial
c) Where applicable an audit certificate should be issued
d) Send the audit report to the IRB.

Answer 23

Regarding the sponsor’s audits of a clinical trial ICH advises all of the following except
d) Send the audit report to the IRB.

Question 24

An adverse drug reaction is
a) A congenital birth defect caused by a drug
b) An event described in the Adverse Drug Reaction Tabulation at the FDA
c) A repeat hospitalization caused by progression of disease
d) A noxious and unintended response to a drug at any dose

Answer 24

An adverse drug reaction is
d) A noxious and unintended response to a drug at any dose

Question 25

A response to a medical product in the context of an adverse drug reaction is best defined as
a) An event documented in the medical record
b) A death
c) A causal relationship between a drug and an adverse event that is possible
d) An event that occurs in the time frame of drug administration

Answer 25

A response to a medical product in the context of an adverse drug reaction is best defined as
c) A causal relationship between a drug and an adverse event that is possible

Question 26

A possible relationship of an adverse drug reaction to a drug may be defined as one
a) Reported by the patient
b) Suspected by the Principal investigator
c) An event that is discontinued when the drug is discontinued
d) An event in which the relationship cannot be ruled out

Answer 26

A possible relationship of an adverse drug reaction to a drug may be defined as one
d) An event in which the relationship cannot be ruled out.

Question 27

An adverse event is defined as
a) A mild clinical event not associated with hospitalization
b) An episode that interrupts a daily activity
c) An event that requires a doctor’s visit
d) A medical occurrence which may not be causally related to a drug

Answer 27

An adverse event is defined as
d) A medical occurrence which may not be causally related to a drug

Question 28

Which of the following is true?
a) All adverse events are adverse drug reactions
b) All adverse drug reaction may be classified as adverse events
c) An adverse event is never classified as an adverse drug reaction
d) An adverse drug reaction excludes mild adverse events

Answer 28

Which of the following is true?
b) All adverse drug reaction may be classified as adverse events

Question 29

An adverse event is one which occurs
a) Within ten days of drug administration
b) An event which may occur after study treatments have been completed
c) An event which occurs immediately after drug administration
d) An event temporally associated with drug use which may or may not be drug related.

Answer 29

An adverse event is one which occurs
d) An event temporally associated with drug use which may or may not be drug related.

Question 30

Steps to reduce bias in clinical trial include
a) Blinding
b) Masking
c) Randomization
d) All of the above

Answer 30

Steps to reduce bias in clinical trial include
d) All of the above

a) Blinding
b) Masking
c) Randomization