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ICH Good Clinical Practice E6

(R2)
RETAKE

100% complete

Quiz

Please ensure you have answered all questions before clicking the
‘submit’ button

Summary

Score for this module: 72%

1. Which of the following is NOT a principle of GCP: (Please

select all that apply)
Any foreseeable risks and inconveniences must be
weighed up against any benefits
Information must be recorded, handled and stored in
a manner that allows accurate reporting,
interpretation and verification and which ensures the
confidentiality of participants’ records.
Publication of results is not required if the study
results were not as expected. Your correct answer

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The study protocol must provide inclusion and

exclusion criteria, monitoring details and a
publication policy.
Available non-clinical and clinical information on the
investigational medicinal product being used must be
adequate to support the study.
The study must be conducted according to the
Nuremberg Code of 1947

2. ICH-GCP guidelines are a legal requirement and studies

found not following it will be terminated.
True Your answer
False

3. It is important for investigators in low-and middle-income

countries to adopt good clinical practice guidelines
because their studies will conseque…
True Your correct answer
False

4. Which of the following is NOT true about the informed

consent process: (Please select all that apply)
IEC/IRB approval must be gained for all participant
related materials and documents.
Details of any alternative treatments/options
must be given to participants after they have
given consent Your correct answer
Consent must be given freely without coercion or
undue influence.
A participant can withdraw from the study at any
time without providing a reason.
If the participant cannot read or write the consent
form can be marked/signed at any time during
participation as long as the participant has agreed to
join the study.

5. As long as you document the entire process, you can

unblind a participant at the request of a site investigator
who wants to enter the participant …
True
False Your correct answer

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6. Participants in a study with an investigational medicinal

product should only contact the study physician if feeling
unwell if their own physician …
True
False Your correct answer

7. Approval from the IEC/IRB is not required for which of the

following:
Study management plan
Study protocol Your answer
Compensation plans

8. The IMP temperature was not recorded for 3 days,

according to protocol this should have been monitored
daily; who will you hold responsible?
Laboratory technician
Sponsor
Investigator Your correct answer
Nurse

9. The protocol is replaced by which of the following:

GCP guidelines
Standard operating procedures
Statistical analysis plan
Study management plan
None of the above Your correct answer
All of the above

10. AEs and SAEs, as defined by the protocol, are:

Only recorded in the case of severe injury or death
Carefully and systematically recorded Your correct
answer
A routine part of all studies and should be ignored

11. Suspension or termination of the study by the

investigator should be reported to which of the following
groups:
Sponsor
DSMB
IEC/IRB
Collaborators

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All of the above Your correct answer

12. The investigator involved in running a study should be

qualified by: (Please select all that apply)
Training Your correct answer
Education Your correct answer
The World Health Organisation
Experience Your correct answer
An academic institution

13. Which of the following are GCP responsibilities of the

investigator: (Please select all that apply)
Ensuring all study staff are sufficiently qualified
Your correct answer
Communication with participants family members
Compliance with study protocol Your correct
answer
Compensation of study participants
Reporting Serious Adverse Events Your correct
answer

14. What does IEC Stand for?

Investigational Ethics Committee
International Ethics Committee
Institutional Ethics Committee
Independent Ethics Committee Your correct
answer

15. Which of the following are key principles of GCP (Please

select all that apply)
The rights, safety and well-being of participants
always take precedence over the interests of
science and society. Your correct answer
Individuals involved in running studies should be
qualified by training to perform their tasks. Your
correct answer
The research protocol must receive approval from
the IEC/ IRB and needs to be followed Your correct
answer
Investigational products must be used in
accordance with the standard operating
procedure. Your answer

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16. When conducting a clinical trial in accordance with GCP,

what is the most important consideration above all else?
Protection of participants Your correct answer
Protocol adherence
Accuracy of data
Quality checks

17. In accordance with GCP the investigator must ensure

which of the following: (Please select all that apply)
Recruitment of an adequate number of
participants Your correct answer
An appropriate amount of time is scheduled to
carry out and complete the study effectively Your
correct answer
Appropriate facilities for the duration of the study
Your correct answer
All staff receive appropriate training on the study
protocol, the investigational product and their
duties Your correct answer

18. Clinical studies should be run applying GCP principles

because:
Applying the principles means that the investigator
does not have to follow the study protocol
It means that the study will be run to a standard
which assures the credibility and accuracy of the
data and reported results Your correct answer
Demonstrating that GCP principles are being followed
means the study does not need to be audited

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DOWNLOAD MATERIALS:

This Course (PDF)

CONTENT NAVIGATION

1. Contents
2. Course Objectives
3. What is Good Clinical
Practice
1. What is Good Clinical
Practice

4. Who is Involved with GCP?

5. Recognition of GCP
6. Being GCP Qualified
7. Investigators' GCP
Responsibilities
1. Gaining informed consent
from study participants
1. Gaining informed
consent from study
participants
2. Gaining informed
consent from study
participants

2. Randomisation
procedures and
unblinding
3. Medical care of
participants
4. IEC/IRB communication
and approvals
5. Investigational product(s)
management
6. Study protocol
compliance
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7. Investigator qualifications
and agreements
1. Investigator
qualifications and
agreements

8. Records and reports

management
1. Records and reports
management

9. Safety reporting
1. Safety reporting

10. Ensuring adequate

resources
11. Management of
premature termination or
suspension of a trial
12. Progress reporting and
final reports
8. Practical application of GCP
9. Key Points to Remember
10. References and Resources
11. Quiz

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