Exam Practice Questions

Question 1

A research study, in which there is no intended clinical benefit to the subject, is being submitted to the IRB/IEC. What benefit information should be included in the ICF?

a. The benefits section should be left out of the ICF, as it is not applicable.

b. Wording indicating that there is no expected benefit should be included.

c. A section on the benefits of clinical research in general should be added.

d. A description of the subject visit stipends should be included as a benefit.

Answer 1

b. Wording indicating that there is no expected benefit should be included.

Question 2

When would an impartial witness be needed during the consent process for an illiterate subject?

a. To explain the consent form

b. To be present for the signature

c. To observe the consent process

d. To assist when the LAR is not available

Answer 2

c. To observe the consent process

Question 3

A blood sample collection is required to screen for bloodborne pathogens before subject could be enrolled in a study. Where will subjects find information of the procedures and any foreseeable risks or inconveniences?

a. Study outline

b. Study protocol

c. CRO’s website

d. ICF

Answer 3

d. ICF

Question 4

A medical student is approached by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the subject?

a. Consenting in the presence of PI

b. Offering a stipend for participating in the study

c. Allowing flexibility in scheduling research visits

d. Consenting in the presence of figure of authority

Answer 4

d. Consenting in the presence of figure of authority

Question 5

An unconscious adult subject was enrolled in a study after obtaining consent from an LAR, and protocol therapy was initiated. The subject showed significant improvement in his clinical condition, and regained consciousness. The Investigator should inform the subject about the study and:

a. obtain assent from the subject for the study.

b. tell the subject he is benefiting from the study therapy.

c. obtain consent from the subject for the study.

d. tell the subject that an LAR provided consent for his participation.

Answer 5

c. obtain consent from the subject for the study.

Question 6

In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF?

a. The subject’s primary physician

b. The subject’s legally acceptable representative

c. The impartial witness

d. The subject’s significant other

Answer 6

b. The subject’s legally acceptable representative

Question 7

An investigator is notified by the sponsor that a study will terminate. The PI would like to continue to follow the subjects for another year. What should the PI do?

a. Continue following the subjects in the study

b. Request permission from the IRB/IEC to continue the study

c. Consent subjects to a new IRB/IEC approved protocol

d. Request IP from the sponsor to continue the study

Answer 7

c. Consent subjects to a new IRB/IEC approved protocol

Question 8

Which of the following is an optional section of the IB?

a. Safety and Efficacy

b. Marketing Experience

c. Non-clinical Studies

d. Signature Page

Answer 8

d. Signature Page

Question 9

A PI is having challenges retaining subjects in the follow-up portion of a clinical trial. He decides to offer gift cards to them for each visit they attend. What should the PI do to initiate this option?

a. Tell the CRC to purchase the gift cards and notify patients

b. Tell the sponsor and have the sponsor purchase gift cards

c. Wait for IRB approval and then purchase gift cards

d. Wait for sponsor approval and then purchase gift cards

Answer 9

c. Wait for IRB approval and then purchase gift cards

Question 9

A PI wants to start a clinical trial on acute stroke patients. Most of the patients will not be conscious when they arrive at the hospital with their family. Which of the following is true regarding the unconscious patients?

a. Consent can be waived.

b. They should not be included in this study.

c. They can only be included if an independent physician agrees.

d. They will need a LAR to consent on their behalf.

Answer 9

d. They will need a LAR to consent on their behalf.

Question 9

When conducting the informed consent process with a potential subject, what is the most important aspect of consent?

a. The patient has read the consent

b. The patient has signed the consent

c. The patient significant other is with him

d. The person understands the language of the consent

Answer 9

d. The person understands the language of the consent

Question 9

New safety information has become available from the Sponsor about the IP being used in a clinical trial. The Investigator must:

a. email each participant with the new safety information.

b. submit a revised ICF to the IRB/IEC noting the new safety information.

c. discuss the new safety information on the phone with participants.

d. make a note in the patient chart.

Answer 9

b. submit a revised ICF to the IRB/IEC noting the new safety information.

Question 9

A PI wants to start a clinical trial on car accident victims. Most of the patients will be conscious when they arrive at the hospital with their families, but they will be in shock. Which of the following is true?

a. The consent discussion must be conducted after the hospital staff finished treating the patient.

b. The potential subjects will not be involved in the consent discussion since they are incapacitated.

c. The potential subjects can provide consent for themselves since they are conscious.

d. As soon as capacity is regained, the subjects should confirm their consent to remain in the study.

Answer 9

d. As soon as capacity is regained, the subjects should confirm their consent to remain in the study.

Question 10

Following the completion of the first phase III study the sponsor has decided to begin studying the IP in the pediatric population. How should the sponsor proceed?

a. Use the current protocol and insert the word pediatric subject as appropriate.

b. Develop a pediatric specific protocol

c. Decide it is futile to conduct studies in the pediatric population

d. Write an amendment to change the inclusion/exclusion criteria to include younger people in the study.

Answer 10

b. Develop a pediatric specific protocol

Question 10

A subject is enrolled in a clinical trial by obtaining consent from a LAR. The subject is asked to consent 3 days later and refuses participation in the study. The CRA arrives onsite to monitor the data collected up to day 3. Is the CRA able to see source documents?

a. Yes, because there is consent on file.

b. No, because subject withdrew consent.

c. Yes, because data can be used up to the date of withdrawal from the study.

d. No, because the LAR consent does not apply.

Answer 10

b. No, because subject withdrew consent.

Question 10

When should a research study involving human subjects be registered in a publicly accessible database?

a. Before recruiting the first subject

b. After recruiting the last subject

c. Before the first site is selected

d. After the interim analysis

Answer 10

a. Before recruiting the first subject

Question 11

A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be:

a. Phase I

b. Phase II

c. Phase III

d. Phase IV

Answer 11

b. Phase II

Question 12

A pediatric dermatologist wishes to be PI on a new study looking at blood serum levels of a new pediatric leukemia drug. The study requires a high number of blood draws but is still an acceptable volume. The sponsor has provided the IB and the PI has evaluated the risk/benefit of the IP, signed off on the protocol, and submitted to the central IRB/IEC for the study. The IRB/IEC sends back a disapproval of the research submission. What is the most-likely reason the IRB/IEC returned a not favorable opinion to the PI?

a. The submission should have been to the institutional IRB/IEC.

b. Risk to pediatric subjects is too high due to the blood volume required.

c. The risk/benefit evaluation of the IP is unfavorable.

d. The Investigator is not qualified to be PI on this study.

Answer 12

d. The Investigator is not qualified to be PI on this study.

Question 13

During an interim monitoring visit, the CRA observes a recruitment poster that has not been approved for use by the IRB/IEC hanging in the hospital elevator. What is the CRA’s next action?

a. Remove the unapproved poster.

b. Report the GCP violation to the sponsor.

c. Report the GCP violation to the IRB/IEC.

d. Report the GCP violation to the PI.

Answer 13

d. Report the GCP violation to the PI.

Question 14

A serious adverse event is one that is:

a. severe.

b. life-threatening.

c. related to IP.

d. not related to IP.

Answer 14

b. life-threatening.

Question 15

Per ICH, an IRB/IEC must keep correspondence for at least how long after the completion of a clinical trial?

a. 2 years

b. 3 years

c. 15 years

d. 25 years

Answer 15

b. 3 years

Question 16

A CRA notices during an onsite visit that the date on IRB/IEC approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST?

a. Confirm dates of initial receipt of the sponsor protocol and the IRB/IEC submission dates.

b. Ask the IRB/IEC to correct the approval letter since they made a mistake.

c. Ask the sponsor and PI to update the signatory page.

d. Submit the protocol deviation to the IRB/IEC.

Answer 16

a. Confirm dates of initial receipt of the sponsor protocol and the IRB/IEC submission dates.

Question 17

In a multi-arm, randomized clinical trial, one arm of the protocol was terminated due to an increased risk of breast cancer in the subjects. Who is responsible for providing a written report to the IRB/IEC?

a. CRC

b. Sponsor

c. PI

d. CRA

Answer 17

c. PI

Question 18

Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the:

a. Sponsor and regulatory authorities.

b. IRB/IEC and PI.

c. regulatory authorities and IRB/IEC.

d. PI and Sponsor.

Answer 18

d. PI and Sponsor.

Question 19

A site is screening potential subjects for a study looking at mild cognitive impairment. One of the inclusion criteria is a score of 25 or less on a psychometric test, a research-specific tool which measures cognitive ability. Which of the following individuals can administer the psychometric test to the potential subjects?

a. A sponsor representative who is experienced in using the psychometric test.

b. A research assistant who is certified to administer the psychometric test.

c. The PI who is familiar with these patients and their cognitive ability.

d. A new CRC who is very familiar with this patient population.

Answer 19

b. A research assistant who is certified to administer the psychometric test.

Question 20

After completion of a study, the final trial close-out monitoring report prepared by the CRA should be filed in which of the following stakeholder files?

a. The sponsor’s files

b. The investigator’s files

c. The sponsor’s and the investigator’s files

d. The investigator’s, the sponsor’s, and the IRB/IEC’s files

Answer 20

a. The sponsor’s files

Question 21

During a multi-site clinical study, whose responsibility is it to report subject recruitment rate?

a. The CRA

b. The IRB Chair

c. The Medical Monitor

d. The statistician

Answer 21

a. The CRA

Question 22

If the IRB/IEC terminates or suspends its approval/favorable opinion of a trial, the investigator/institution should promptly notify the:

a. Sponsor

b. IRB/IEC

c. Subjects

d. Monitor

Answer 22

a. Sponsor

Question 23

A PI on a currently enrolling study has decided to discontinue participation in the study for personal reasons. In addition to notifying the study sponsor, who else should the investigator/institution notify:

a. Other Study Investigators

b. Regulatory Authority

c. IRB/IEC

d. CRO

Answer 23

c. IRB/IEC

Question 24

A sponsor is developing an IP for treatment of a medical condition where there is one additional marketed product approved for treatment of the condition. The sponsor believes their product works as well or better than the current treatment with fewer side effects. What is the most-likely study design they will use to test the efficacy of the IP?

a. Superiority

b. Equivalence

c. Non-inferiority

d. Dose-response

Answer 24

c. Non-inferiority

Question 25

Centralized monitoring supports clinical data review by:

a. Eliminating the need for onsite visits

b. Requiring a call to the PI

c. Examining data trends

d. Identifying fraud

Answer 25

c. Examining data trends

Question 26

A sponsor decides to use the services of a CRO for a proposed study. What is required for this to happen?

a. Any trial-related duty must be specified in writing.

b. Favorable opinion from the IRB/IEC.

c. No contract is required if they are a preferred vendor.

d. A verbal agreement is all that is needed.

Answer 26

a. Any trial-related duty must be specified in writing.

Question 27

When can IP be shipped to the trial site?

a. After filing the PI with the regulatory agency

b. After the site initiation visit

c. After the investigator meeting

d. After IRB/IEC approval

Answer 27

d. After IRB/IEC approval

Question 28

When considering participation in a study, the investigator should determine if he/she:

a. sees enough patients who would qualify for the study.

b. has ever used the EDC system that will be used for the study.

c. has any financial stake in the sponsor’s stock.

d. can obtain IRB/IEC approval of advertisement material.

Answer 28

a. sees enough patients who would qualify for the study.

Question 29

A site is in the start-up phase of an industry-sponsored phase 3 trial, and has received IRB/IEC approval. The site can begin enrolling subjects after:

a. the CRA has conducted a site initiation visit.

b. the first DSMB/IDMC meeting report has been issued.

c. the site receives approval from the medical monitor to begin enrolling.

d. a signed clinical trial agreement between the site and sponsor is in place.

Answer 29

d. a signed clinical trial agreement between the site and sponsor is in place.

Question 30

A research subject’s responsibilities for study participation should be described in the:

a. protocol.

b. patient diary.

c. IRB/IEC submission.

d. ICF.

Answer 30

d. ICF.

Question 31

What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial?

a. Inform the subject’s primary physician about the withdrawal.

b. Explain the benefits of continued participation in the trial.

c. Try to obtain the subject’s reason for withdrawal.

d. Obtain sponsor approval to withdraw the subject.

Answer 31

c. Try to obtain the subject’s reason for withdrawal.

Question 32

Which of the following is the best way to assess subject compliance taking once-daily IP?

a. Dispensing 30 days of IP to the subject and asking them to return on day 29 for their next batch.

b. Calling the subject weekly and asking them to report if they have taken IP for the last week.

c. Providing blister packs with the “date to be taken” indicated on the package for each pill.

d. Counting the number of pills returned and not taken, at the subject’s next follow-up visit.

Answer 32

d. Counting the number of pills returned and not taken, at the subject’s next follow-up visit.

Question 33

What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP?

a. Protocol

b. Clinical study report

c. Product monograph

d. Investigator’s brochure

Answer 33

d. Investigator’s brochure

Question 34

Which of the following required elements should be included in a clinical trial protocol?

a. The subject’s responsibilities

b. The alternative treatments that may be available to the subject

c. The subject inclusion and exclusion criteria

d. The compensation available to the subject for trial-related injury

Answer 34

c. The subject inclusion and exclusion criteria

Question 35

The primary purpose of blinding a clinical trial is to:

a. compare the efficacy of a two established treatments.

b. ensure equal number of subjects in each treatment arm.

c. prevent identification of the treatment a subject receives.

d. randomly assign subjects to the treatment arms.

Answer 35

c. prevent identification of the treatment a subject receives.

Question 36

Under what circumstance can breaking the blind during the study be considered?

a. During an inspection by the regulator agency.

b. If the subject wishes to know their treatment assignment.

c. During interim analysis.

d. When knowledge of the treatment is essential for medical care of the subject.

Answer 36

d. When knowledge of the treatment is essential for medical care of the subject.

Question 37

A Phase III clinical trial evaluating IP versus a placebo is to be conducted in children. Which of the following can be considered a rationale for conducting the study?

a. It will be easier to recruit from a pediatric than an adult population.

b. There is no current treatment for the indication in children.

c. The results of the study can be used to find out safety information about the IP.

d. The investigators want to learn about the pharmacokinetics of the IP.

Answer 37

b. There is no current treatment for the indication in children.

Question 38

A PI wants to conduct a study proving drug A is a good treatment option; better than no drug and better than drug B, which currently is the only marketed treatment option. The study design involves two study arms, where subjects are randomized 1:1 to receive either drug A or drug B. Is this a good study design to answer the question?

a. Yes, because it compares drug A to drug B.

b. Yes, because it randomizes the subjects.

c. No, because it needs another study arm.

d. No, because drug B is the approved standard.

Answer 38

c. No, because it needs another study arm.

Question 39

What type of clinical trial most likely requires enrollment of the largest number of research subjects?

a. Therapeutic use

b. Pharmacokinetic

c. Therapeutic exploratory

d. Therapeutic confirmatory

Answer 39

d. Therapeutic confirmatory

Question 40

During a monitoring visit, what records would a CRA reference to verify a subject’s compliance to the study visit schedule and assessments?

a. Clinic’s appointment schedule

b. Electronic Medical Record

c. Drug accountability records

d. Recruitment log

Answer 40

b. Electronic Medical Record

Question 41

A CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for:

a. validation, accuracy, reliability, and completeness.

b. accuracy, validation, readability, and completeness.

c. completeness, editability, accuracy, and readability.

d. editability, validation, completeness, and dependability.

Answer 41

a. validation, accuracy, reliability, and completeness.

Question 42

Part of a sponsor’s responsibility pertaining to electronic trial data handling is to:

a. provide a guidance document for changing the electronic trial data handling system.

b. maintain an audit trail, data trail, and edit trail.

c. maintain a list of all user passwords.

d. ensure that the systems are designed to completely eliminate data entry errors.

Answer 42

b. maintain an audit trail, data trail, and edit trail.

Question 43

Which of the following documents are required to be maintained in the sponsor files?

a. Subject recruitment advertisements

b. Signed Informed Consent Forms

c. Subject Identification Code List

d. Monitoring Visit Reports

Answer 43

d. Monitoring Visit Reports