ICH Good Clinical Priniciples Part 2

Question 1

According to ICH the investigator should promptly report the following to the IRB:
a) Deviations from protocol to eliminate immediate hazards
b) Changes in risk in protocol
c) Serious and unexpected adverse drug reactions
d) New information that may affect the safety of subjects
e) All of the above

Answer 1

According to ICH the investigator should promptly report the following to the IRB:
e) All of the above

a) Deviations from protocol to eliminate immediate hazards
b) Changes in risk in protocol
c) Serious and unexpected adverse drug reactions
d) New information that may affect the safety of subjects

Question 2

According to ICH, the sponsor may request the following from the IRB
a) A copy of the minutes of an IRB meeting
b) IRB correspondence with OHRP
c) Rationale for IRB disapproval
d) Written procedures and membership lists

Answer 2

According to ICH, the sponsor may request the following from the IRB
d) Written procedures and membership lists.

Question 3

According to ICH the investigator should
a) Demonstrate the potential for recruiting the required number of subjects
b) Have sufficient time and staff to conduct the trial
c) Ensure that the delegated staff be informed about the protocol, duties and product
d) All of the above

Answer 3

According to ICH the investigator should
d) All of the above

a) Demonstrate the potential for recruiting the required number of subjects
b) Have sufficient time and staff to conduct the trial
c) Ensure that the delegated staff be informed about the protocol, duties and product

Question 4

According to ICH the investigator should
a) Ascertain the reason for withdrawal of a subject
b) Inform a subject’s physician about subject participation in a clinical trial
c) Ensure that adequate care is provided for any adverse event experienced by the subject
d) All of the above

Answer 4

According to ICH the investigator should
d) All of the above

a) Ascertain the reason for withdrawal of a subject
b) Inform a subject’s physician about subject participation in a clinical trial
c) Ensure that adequate care is provided for any adverse event experienced by the subject

Question 5

With regard to keeping the IRB informed about the Investigator’s brochure, ICH states that
a) It is the sponsor’s responsibility
b) It is the investigator’s responsibility
c) It is not needed
d) Updates to the brochure need not be provided.

Answer 5

With regard to keeping the IRB informed about the Investigator’s brochure ICH states that
b) It is the investigator’s responsibility.

Question 6

If the investigator implements a change in the protocol to eliminate an immediate hazard the following entities should be informed:
a) The IRB
b) The sponsor
c) Regulatory authority if applicable
d) All of the above

Answer 6

If the investigator implements a change in the protocol to eliminate an immediate hazard the following entities should be informed:
d) All of the above

a) The IRB
b) The sponsor
c) Regulatory authority if applicable

Question 7

ICH recommends that responsibility for the investigational product and its accountability be assigned to
a) The sub-investigator
b) The research coordinator
c) The study monitor
d) The pharmacist

Answer 7

ICH recommends that responsibility for the investigational product and its accountability be assigned to
d) The pharmacist

Question 8

Drug accountability for the investigational product includes
a) Delivery and inventory at the trial site
b) Use and return of the product
c) Batch, serial numbers and expiration dates
d) All of the above

Answer 8

Drug accountability for the investigational product includes
d) All of the above

a) Delivery and inventory at the trial site
b) Use and return of the product
c) Batch, serial numbers and expiration dates

Question 9

With regard to randomization the investigator should:
a) Follow the sponsor’s randomization plan
b) Explain to the sponsor any premature unblinding due to an adverse event
c) Both a and b
d) Neither a nor b

Answer 9

With regard to randomization the investigator should:
c) Both a and b

a) Follow the sponsor’s randomization plan
b) Explain to the sponsor any premature unblinding due to an adverse event

Question 10

According to ICH the informed consent should be
a) Signed but not dated by the subject
b) Signed and dated by the subject only
c) Signed and dated by the subject and the person obtaining consent
d) Witnessed for all consent situations

Answer 10

According to ICH the informed consent should be
c) Signed and dated by the subject and the person obtaining consent.

Question 11

Features of the informed consent in ICH which differ from DHHS guidelines include all of the following except
a) The probability of assignments to each treatment group
b) The risks and benefits of alternative treatments
c) The access to the subject’s medical records for the monitor, auditor and IRB
d) The anticipated expenses for the subject
e) The number of subjects in the trial.

Answer 11

Features of the informed consent in ICH which differ from DHHS guidelines include all of the following except
e) The number of subjects in the trial.

Question 12

The ICH guidelines differ from DHHS guidelines in that they
a) Describe in detail the features of a non-therapeutic trial
b) Describe the process of managing non-therapeutic trials
c) Affirm the need for signed and dated consent and IRB approval of non-therapeutic trials
d) All of the above

Answer 12

The ICH guidelines differ from DHHS guidelines in that they
d) All of the above

a) Describe in detail the features of a non-therapeutic trial
b) Describe the process of managing non-therapeutic trials
c) Affirm the need for signed and dated consent and IRB approval of non-therapeutic trials

Question 13

The following agreements between sponsor and investigator should be documented in writing
a) Financial arrangements and contracts
b) Protocol agreement document
c) Investigator’s brochure receipt and confidentiality document
d) All of the above

Answer 13

The following agreements between sponsor and investigator should be documented in writing
d) All of the above

a) Financial arrangements and contracts
b) Protocol agreement document
c) Investigator’s brochure receipt and confidentiality document

Question 14

According to ICH the case report forms should be
a) Consistent with source documents
b) Dated, initialed and explained when needed
c) Show the original when corrections are made
d) All of the above

Answer 14

According to ICH the case report forms should be
d) All of the above

a) Consistent with source documents
b) Dated, initialed and explained when needed
c) Show the original when corrections are made

Question 15

Serious adverse events in a clinical trial should be reported to the sponsor according to
ICH
a) Immediately
b) Within one day
c) Within one week
d) As time permits

Answer 15

Serious adverse events in a clinical trial should be reported to the sponsor according to
ICH
a) Immediately

Question 16

When the IRB suspends a clinical trial it should inform
a) The institution
b) The sponsor
c) OHRP
d) All of the above

Answer 16

When the IRB suspends a clinical trial it should inform
d) All of the above

a) The institution
b) The sponsor
c) OHRP

Question 17

According to ICH the ultimate responsibility for the quality and integrity of the data rests with
a) The investigator
b) The research coordinator
c) The site monitor and CRO
d) The sponsor

Answer 17

According to ICH the ultimate responsibility for the quality and integrity of the data rests with
d) The sponsor

Question 18

Under ICH the sponsor’s responsibilities for electronic data handling includes all of the following except
a) Accuracy, reliability and consistent performance guided by SOPs
b) Security and backup of the system and access to authorized individuals only
c) Safeguarding of the blinding
d) Part 11 compliance

Answer 18

Under ICH the sponsor’s responsibilities for electronic data handling includes all of the following except
d) Part 11 compliance

Question 19

If the sponsor discontinues clinical development of a drug the records of a clinical trial should be retained for
a) One year
b) Two years
c) Three years
d) Four years

Answer 19

If the sponsor discontinues clinical development of a drug the records of a clinical trial should be retained for
b) Two years

Question 20

In ICH, with regard to the retention of records by the investigator, the sponsor
a) Can request retention for as long as the sponsor needs the data
b) Can request retention for at least two years post NDA approval, according to FDA guidelines
c) Should notify the investigator in writing when the records are no longer needed
d) All of the above

Answer 20

In ICH, with regard to the retention of records by the investigator, the sponsor
d) All of the above

a) Can request retention for as long as the sponsor needs the data
b) Can request retention for at least two years post NDA approval, according to FDA guidelines
c) Should notify the investigator in writing when the records are no longer needed

Question 21

According to ICH the purpose of monitoring is
a) Protect the rights and well-being of human subjects
b) Ensure data are accurate complete and verifiable
c) The conduct of the trial is in agreement with the protocol, GCP and regulatory
requirements
d) All of the above

Answer 21

According to ICH the purpose of monitoring is
d) All of the above

a) Protect the rights and well-being of human subjects
b) Ensure data are accurate complete and verifiable
c) The conduct of the trial is in agreement with the protocol, GCP and regulatory
requirements

Question 22

With regard to the training of monitors ICH states that they should be
a) Appropriately trained with documented qualifications
b) Have the needed scientific and clinical knowledge
c) Familiar with the protocol and the consent form
d) All of the above

Answer 22

With regard to the training of monitors ICH states that they should be
d) All of the above

a) Appropriately trained with documented qualifications
b) Have the needed scientific and clinical knowledge
c) Familiar with the protocol and the consent form

Question 23

In determining the extent of monitoring, the sponsor should consider
a) Objective, design, complexity, blinding and size
b) Objective, payments, complexity, blinding, cost
c) Objective, drug supply, payments, complexity, cost
d) Objective, site support, payments, complexity, blinding

Answer 23

In determining the extent of monitoring the sponsor should consider
a) Objective, design, complexity, blinding and size

Question 24

The monitor should
a) Serve as the person who decides on whether a trial should continue at the site
b) List complaints about Pl behavior
c) Train the research coordinator in their daily duties
d) Serve as the main line of communication between the sponsor and the investigator.

Answer 24

The monitor should
d) Serve as the main line of communication between the sponsor and the investigator.

Question 25

With regard to the investigator, the monitor should
a) Verify that the investigator has adequate qualifications, resources, facilities and staff
b) Verify whether the investigator meets regularly with staff
c) Verify whether the investigator is delivering on all 1572 commitments
d) Check on the Pl’s characteristics by talking to staff.

Answer 25

With regard to the investigator the monitor should
a) Verify that the investigator has adequate qualifications, resources, facilities and staff.

Question 26

With regard to drug accountability the monitor should
a) Verify storage items and adequacy of supplies
b) Verify whether eligible patients are getting the drug at the right doses
c) Verify whether subjects are informed and trained about drug use and storage
d) Verify the receipt, use, return and disposition of unused drug
e) All of the above

Answer 26

With regard to drug accountability the monitor should
e) All of the above

a) Verify storage items and adequacy of supplies
b) Verify whether eligible patients are getting the drug at the right doses
c) Verify whether subjects are informed and trained about drug use and storage
d) Verify the receipt, use, return and disposition of unused drug

Question 27

The study monitor reviews case report forms during
a) Routine site visits
b) Site initiation visit
c) Study close out visit
d) Pre-study visit

Answer 27

The study monitor reviews case report forms during
a) Routine site visits

Question 28

The study monitor verifies final disposition of unused drug during
a Routine site visits
b) Site initiation visit
c) Study close out visit
d) Pre-study visit

Answer 28

The study monitor verifies final disposition of unused drug during
c) Study close out visit

Question 29

The study monitor reviews the protocol and schedule of assessments with the staff during
a) Routine site visits
b) Site initiation visit
c) Study close out visit
d) Pre-study visit

Answer 29

The study monitor reviews the protocol and schedule of assessments with the staff during
b) Site initiation visit

Question 30

The study monitor assesses the investigator’s qualification, resources and facilities during
a) Routine site visits
b) Site initiation visit
c) Study close out visit
d) Pre-study visit

Answer 30

The study monitor assesses the investigator’s qualification, resources and facilities during
d) Pre-study visit

Question 31

The study monitor should verify all of the following except
a) Informed consents
b) Receipt and distribution of current copies of the investigator’s brochure
c) Delegation of duties to staff
d) Eligibility of enrolled subjects
e) Recruitment rate
f) Case report forms and source documents
g) Record of failed visits and tests and procedures not done
h) The budget for the site and accuracy of financial disclosures

Answer 31

The study monitor should verify all of the following except
h) The budget for the site and accuracy of financial disclosures

Question 32

The site monitor’s findings should be summarized in
a) Periodic site monitoring reports
b) E-mails to the investigator
c) Verbal communication with research coordinators
d) Summarized at the close out visits

Answer 32

The site monitor’s findings should be summarized in
a) Periodic site monitoring reports

Question 33

According to ICH when non-compliance which is serious or persistent is observed, the sponsor should
a) Terminate the investigator’s participation in the clinical trial
b) Inform the IRB
c) Inform the regulatory authorities
d) All of the above

Answer 33

According to ICH when non-compliance which is serious or persistent is observed the sponsor should
d) All of the above

a) Terminate the investigator’s participation in the clinical trial
b) Inform the IRB
c) Inform the regulatory authorities

Question 34

According to ICH in multi-center trials the sponsor should
a) Carefully define the responsibilities of the coordinating site principal investigator
b) Delegate monitoring to the coordinating site
c) Allow different standards of compliance depending on the site
d) Permit changes in the CRFs for sites that may suggest these

Answer 34

According to ICH in multi-center trials the sponsor should
a) Carefully define the responsibilities of the coordinating site principal investigator.

Question 35

Regarding protocol and GCP deviations observed by the monitor in a periodic site visit the sponsor may
a) Require that these be reported promptly to the IRB
b) Institute a corrective measure promptly
c) Develop a CAPA plan as needed
d) All of the above

Answer 35

Regarding protocol and GCP deviations observed by the monitor in a periodic site visit the sponsor may
d) All of the above

a) Require that these be reported promptly to the IRB
b) Institute a corrective measure promptly
Develop a CAPA plan as needed