CCR Orientation to Clinical Trials

Answer key

Name: ___________________________

1. Which one of the following characterizes phase I drug testing?

a. It may involve patients with different kinds of cancer.

b. It is limited to patients who have highly effective treatment alternatives.
c. It uses a single dose level to ascertain response rates.
d. It always involves completely predictable toxicities.

2. Which one of the following characterizes phase II drug testing?

a. It uses a single dose of drug determined from the Phase I experience.

b. It always treats divergent pathologies in a single trial.
c. It is the first human clinical experience with a new agent.
d. It always leads to a new drug approval from FDA.

3. Which of the following characterizes phase III drug testing?

a. It usually requires small patient numbers.

b. It can be done without approval.
c. It usually involves a comparison between different treatments.
d. It always demonstrates superiority of the new approach.

4. Which one of the following characterizes animal models in drug

development?

a. They are always limited to the mouse model.

b. They always require primate drug development.
c. They remain important in the drug development process.
d. They have been entirely eliminated by modern technology.

5. All of the following must be determined prior to initiating a clinical trial

EXCEPT:

a. The number of patients needed to evaluate protocol sample size

b. The required laboratory tests and X-rays
c. The study design, i.e. randomized or single-arm trial
d. The degree to which the trial outcomes are met
e. The eligibility criteria

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 6. The following must be done prior to the first patient being entered on a
clinical trial EXCEPT:

a. Approval by an Institutional Review Board (IRB)

b. A written protocol
c. A written consent
d. Pharmacy process to obtain drug supplies
e. Data analysis

7. Which of the following statements about regulatory requirements is TRUE?

a. If a new toxicity is to be added to the consent form, it should be

submitted to the Institutional Review Board (IRB) for review.
b. The annual review of studies by an IRB can be done at intervals of greater
than 12 months, as long as no new patients have been entered on the study
since the last review.
c. The only time an Adverse Event Report must be filed is when a patient dies
while receiving the drug.
d. The IRB may review a study without a quorum being present as long as the
investigator is present to vote.
e. If the pharmacy has some of the investigational drug left over after the study
is closed, it can be used to treat other patients until all leftover supplies are
exhausted.

8. Currently, consent documents for the general population be written at what

grade level?

a. 4th grade
b. 8th grade
c. 12th grade
d. At the investigator’s discretion

9. Which of the following is a required element of an informed consent?

a. Clearly defined potential toxicities

b. A statement that participation is required after consent is signed
c. Guarantee of clinical improvement
d. Guarantee of health care at no cost for the disease under study

10. Tips for ease of comprehending informed consent include all of the following
EXCEPT:

a. Use upper case throughout document.

b. Break content into short sentences.
c. Use font size no smaller than 12 point.
d. Arrange content with subheadings.

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 11. What is the purpose of the Drug Accountability Record?

a. To record the number of study agents consumed by the patient

b. To document control/disposition of investigational medications
c. To calculate patient charges for reimbursement purposes
d. To report the study agent’s dose intensity

12. When a physician is entering a medical order to administer an investigational

agent he must:

a. Order the drug referencing the correct protocol number

b. Order the drug from any protocol which includes the same drug
c. Order the drug from the stock in the investigational laboratory
d. Order the drug prior to patient enrollment

13. For English speaking subjects, FDA regulations require a witness to sign the
consent form.

True False

14. All of the following are common examples of endpoints used in drug
development research EXCEPT:

a. Time to progression
b. Best clinical response
c. Percentage of patients who withdraw from study
d. Quality of Life measures

15. Which of the following FDA documents are “binding” requirements for
investigators conducting drug development research?
1. Laws 3. Guidance documents
2. Regulations 4. GCP (Good Clinical Practice)

a. 1 and 2
b. 1, 2 and 3
c. All of the above
d. None of the above

16. For what purpose does the IRB review the informed consent?

a. Protect the Institution

b. Protect the subject
c. Provide the Institution with information about proposed research trials
d. Protect the Sponsor

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 17. IRB membership includes all of the following EXCEPT:

a. At least five members: varying background and expertise

b. One or more members with ethics background
c. At least one Scientist and one non-scientist
d. At least one person not affiliated with the institution
e. At least one member with regulatory expertise

18. How long must research records be kept?

a. For 2 years
b. For 2 years after FDA approval for general distribution
c. For 7 years after end of study
d. Until last patient on the study dies

19. Which of the following is NOT an ESSENTIAL element of ethical research?

a. Valuable scientific question

b. Balance of risks and benefits
c. Subject selection based on locality
d. Independent review

20. Why do electronic data collection systems hold an advantage over paper-
based systems?

a. Because of the ability to maintain confidentiality of medical records

b. Because of the ability to insure data integrity
c. Because of the ability to review trends and analyze data
d. Because of the ability to insure that all required items are collected for a
clinical trial

21. Electronic data management systems enhance data integrity by:

a. Eliminating redundancy
b. Limiting free-text responses and maximizing the use of standard
vocabularies
c. Validating data values whenever possible
d. All of the above

22. What is the definition of an Adverse Event?

a. Any sign or symptom during the course of a clinical trial
b. Any event which the PI decides to report during the course of a clinical trial
c. Administration of the wrong dose of study agent
d. Patient participating in a clinical trial withdraws from study

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 23. Mr. X is admitted on the research study with a baseline GI assessment of
normal bowel function. During the first cycle of study agent with a pre-
clinical toxicity profile including nausea, diarrhea, alopecia, headache, and
pancytopenia, he experiences 5 liquid stools a day for approximately 3 days
and was treated with 1L IV fluids. Using the Common Terminology Criteria
for Adverse Events (CTCAE) version 3.0, the grade of this AE is _________.

a. Grade 1
b. Grade 2
c. Grade 3
d. Grade 4
e. Unable to assess

24. What is the most likely attribution of this Adverse Event?

a. Unlikely
b. Probably
c. Definitely
d. Unrelated

25. Which of the following are reasons to perform audits as part of your
organization’s Quality Assurance Programs?

a. To assure all patient protection measures are followed

b. To ensure protocol adherence
c. To find and correct errors
d. To ensure study results are valid
e. All of the above

26. Which of the following characterize a Data Safety Monitoring Board?

1. It is an independent committee for the protection of study participants

2. Ensures the evaluation of interim results are made competently
3. Ensures that decisions about continuing, monitoring or terminating the
protocol are unbiased and made competently
4. They must review all phases of clinical trials (I, II, III)

a. 1, 2 and 3 only
b. 2 and 4 only
c. 1 and 4 only
d. All of the above

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 27. All of the following are examples of what auditors/monitors look for during
the audit process EXCEPT:

a. Regulatory binder to include copies of current Clinical Laboratory

Improvement Amendment (CLIA) certificates for all labs used by patients
on a study
b. Copy of the signed informed consent is located in the patient’s medical
record
c. All eligibility criteria are met prior to patient enrollment on study
d. Documentation in the patient’s medical record of study drug administration
including dose, route, missed doses, modified doses

28. What is the purpose of FDA form 1572?

a. It ensures the return or disposition of unused investigational drug supplies.

b. It is an agreement with the “signing” investigator to comply with all
FDA regulations.
c. It ensures that investigational facilities are adequate to conduct the study.
d. It is an agreement with contracted monitors to provide periodic visits
evaluating study implementation.

29. Who is ultimately responsible for ensuring protocol integrity?

a. Principal Investigator
b. Study Coordinator
c. Study Monitor
d. The study research team

30. Why do sponsors conduct monitoring visits?

1. Required by law
2. Try to find new investigators
3. Check on the use of grant money
4. Ensure that subject’s rights are protect

a. 1 and 2
b. 1, 2 and 3
c. 1 and 4
d. All of the above

31. Which of the following is not an objective of routine monitoring visits?

a. To verify that the Investigator is following the protocol.

b. To check on subject enrollment
c. To verify CRF data against source documents
d. To collect completed CRFs
e. To have the investigator sign the Investigator Agreement

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 32. As defined in the Belmont Report, the ethical principle of beneficence related
to the general rule:
a. obtain consent form subjects
b. maximize possible benefits and minimize potential risks
c. the burdens of research should be shared equally
d. the benefits from research should be applied first to those who cannot
afford them

33. To conduct federally funded research, the regulations require institutions to

have which of the following?
a. a Certificate of Confidentiality
b. A contract for goods and services
c. An assurance of compliance with the human subject protection
regulations (e.g., Federal-Wide Assurance)
d. A Business Associate agreement

34. Recruitment advertisements for subjects are considered to be part of the

informed consent process. Therefore, ads must
a. contain all the federal elements of consent
b. be reviewed and approved by the IRB
c. only be in written formats
d. be in both English and expected non-English languages

35. According to the Belmont Report, the process of informed consent requires
three key components to be adequately addressed to be considered ethically
valid. These are:
a. confidentiality, compassion and comprehension
b. information, understanding and voluntary agreement
c. signatures of subject, person obtaining consent and a witness
d. subjects’ signature and date of signature plus receipt of a copy of the form

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