ICH Questions Part 2 Flashcards

1
Q

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

A

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

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2
Q

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

A

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

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3
Q

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

A

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

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4
Q

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

A

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

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5
Q

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.

A

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

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6
Q

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

A

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

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7
Q

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

A

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

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8
Q

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

A

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

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9
Q

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

A

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

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10
Q

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

A

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

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11
Q

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

A

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

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12
Q

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

A

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

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13
Q

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

A

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

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14
Q

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

A

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

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15
Q

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

A

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

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16
Q

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

A

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

17
Q

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

A

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

18
Q

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

A

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

19
Q

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

A

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

20
Q

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.

A

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

21
Q

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.

A

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

22
Q

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

A

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

23
Q

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

A

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

24
Q

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

A

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

25
Q

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

A

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

26
Q

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

A

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

27
Q

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

A

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

28
Q

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

A

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

29
Q

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

A

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

30
Q

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

A

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

31
Q

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

A

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