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QUIZ
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This
quiz consists of
40 questions. Please answer each question by ticking one of the boxes.
You will need to complete all the questions at the same time as there
is no option to save and return. When you have finished, the programme
will calculate your score. You need to achieve at least 75% to pass.
If your score is lower you should re-visit some questions - the incorrect
answers will be highlighted.
The
quiz should take no more than half an hour to complete.
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1. What is the difference between an Adverse Event (AE) and an Adverse Drug Reaction (ADR):
Both terms mean the same
An ADR has some recognized causal relationship with the medicinal product that an AE does not have
An ADR is seen with a marketed product whereas an AE is seen with an experimental drug
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2. Good Clinical Practice is a standard providing assurance that:
The ethics committee will approved the study
The results are of good quality and that the patient's rights are protected
The experimental drug will obtain a marketing approval
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3. An Independent Ethics committee (IEC):
Must review the suitability of the protocol, investigators, facilities and the informed consent process
Must have at least two lay members (non-scientific, non-medical members)
Must meet at least every 6 weeks and return their opinion within 8 weeks of receipt of the documents
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4. An 'investigational product' is:
An active ingredient used in a clinical trial
An active ingredient or a marketed product used in a clinical trial
An active ingredient or a marketed product or a placebo used in a clinical trial
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5. For an Adverse Event or an Adverse Drug Reaction, 'Serious' includes:
Death, life threatening, hospitalisation, disability / incapacity, congenital anomaly / birth defect, but not cancer and overdose
All of the above plus cancer and overdose
Death and life threatening only
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6. An adverse drug reaction is 'unexpected' when:
The investigator did not think it might happen
The monitor did not think it might happen
The nature or severity of the ADR is not consistent with the 'product information'
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7. As an SAE should be reported 'immediately', what is the expected time frame for the investigator to inform
the coordinating centre of a Serious Adverse Event occurring:
Within one hour
Within 24 hours
Within one week
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8. Which of the following documents must be signed and returned to the coordinating centre before a trial can begin at the site:
CV, ethics approval, PI agreement
List of co-investigators, letter of support from your boss
All of the above
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9. A trial should be initiated and continued only if:
The risks are reasonable
The anticipated benefits justify the risks
The benefits are greater than the anticipated risks
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10. The participant's identity is:
Published upon sponsor's or ethics committee request
Communicated at project meetings
Protected respecting privacy and confidentiality
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11. In a clinical trial the most important considerations are:
The interests of science and society
The rights, safety and well-being of the trial participants
The investigator's requests
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12. Each individual conducting a clinical trial should be:
Over 45 years old
Qualified by education, training and experience
Intelligent and multilingual
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13. A trial should be conducted:
In compliance with the protocol approved by the relevant ethics committee
According to the investigator's availability
In compliance with the patient's request
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14. The medical care and the decisions made should be of:
A qualified doctor
A hospital nurse when appropriate
Patients, parents or relatives
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15. Investigational products are:
Manufactured, handled and stored according to Good Manufacturing Practice
Kept with hospital drugs
Stored by the patients
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16. An ethics committee should safeguard rights, safety and well-being of:
All trial participants
Particularly vulnerable participants only
All participants who have not taken part in a previous trial
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17. An ethics committee, at minimum, should obtain and review:
The trial protocol and amendments and investigator brochure
Written information to be provided to participants
All of the above
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18. In certain indications where prior written consent to enter a trial is not possible, an ethics committee should determine that the protocol and/or other documents adequately:
Contain details of all food to be consumed throughout the study
Addresses ethical concerns
Meets the investigator's needs
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19. Which of the following situations would not give rise to a conflict of interest:
The principal investigator is a member of the Ethics Committee evaluating the protocol
The trial is funded by a pharmaceutical company and the principal investigator has agreed not to publish the trial if the results are negative
The principal investigator does not have a financial stake in the outcome of the trial
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20. The investigator should promptly report to the IRB/IEC:
All the protocol deviations, including administrative / logistical issues
All adverse events
Changes that increase risk to the participants
All of the above
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21. Who has the responsibility for the study medication at a site during the study:
The sponsor
The coordinating centre
The investigator
The pharmacist
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22. Patient informed consent forms must be:
A maximum of four pages long
On three part carbon paper
Signed by a witness
Signed and personally dated by the patient (except in an emergency)
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23. Changes or corrections to the CRF should:
Over-write the original entry
Be in red ink in the margin
Always be explained
Endorsed by the investigator
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24. Any discrepancies between source documents and CRF should be:
Highlighted in fluorescent pen
Always amended to be consistent
Explained
Ignored
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25. Who should provide the clinical trial insurance or indemnify the investigator against claims arising from the use of investigational product during the trial (excluding malpractice and/or negligence):
The sponsor
The CRO
The hospital or institution
The investigator's professional association
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26. Access to patient's records (Source Data):
The investigator must agree in writing to providing direct access
The investigator may apply discretion as to which data or documents may be accessed
Patient records should never be available to anyone other than the investigator
The investigator may provide indirect access only to the source data or documents
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27. Unblinding of patient allocation should be done:
By the investigator after a patient completed the study
In the case of patient's death
According to procedures described in the protocol
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28. Statistical methods to be employed during study:
Are a part of the Investigator's Brochure
Are a part of the protocol
Are described separately
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29. The main purpose of the Investigator's Brochure (IB) is to provide:
A list of potential investigators for project managers
The investigators and others involved in the trial with the information to help them to understand key features of the protocol
Promotional material from the sponsor on the investigational product
Guidelines for investigators on conducting a clinical trial
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30. Patient randomisation log has to be filed:
By the PI or delegate
By the coordinating centre
Both
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31. Investigational product(s) accountability at site:
Is necessary for documenting the use of the product according to the protocol
Has to be completed by the PI or delegate
Both of the above
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32. When is it ethical for research participants in the control group of a trial of a diagnostic, therapeutic, or preventive intervention to receive 'placebo' or no treatment:
An established effective intervention is already available
Withholding an established effective intervention would expose participants to, discomfort or delay in relief of symptoms
There is no established effective intervention
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33. All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g. Investigator's Brochure) identifies as not needing immediate reporting:
True
False
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34. Which of the following have the capacity to give legal valid Consent:
Children (less than 16 years old)
Elderly
Patient with severe impairment in level of consciousness due to traumatic brain injury
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35. Which of the following is an advantage of double blind Randomised Controlled Trials (RCTs):
The significance of the results does not have to be tested using statistical methods
Blinding reduces bias on the part of both the investigator and the participant
It does not help assure compliance with the principle of distributive justice, in that all participants have an equal chance of receiving the new therapy and likewise an equal chance of being exposed to the risks of that therapy
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36. A trial planned with an adequate sample size may be flawed by which of the following:
A large number of participants lost to follow-up or by excessive missing data
Using every means possible to reduce loss to follow-up
Designing Case Record Forms to collect only the data required
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37. In measuring outcome, which of the following will minimise measurement bias:
Use of an objective outcome (e.g. death)
Varying the assessment of outcome
Investigators and patients are aware of the treatment allocation
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38. Which of the following best describes 'Statistical Power' of a trial:
Probability you will detect a meaningful difference, or effect, if one were to occur
Probability that a meaningful difference will be detected using a large sample
Probability that you will eliminate a Type I error
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39. All clinical trial information should be:
Kept with hospital records
Stored in a locked room
Accurately recorded, handled and stored
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40. Who is responsible for providing an up to date Investigator's Brochure to the responsible ethics committee:
The sponsor
The coordinating centre
The PI
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