GCP Study 1 Flashcards
GCP Study 1
1
Q
Who is ultimately responsible for Source Data Verification?
a) The coordinator
b) The subject
c) The monitor
d) The investigator
A
c) The monitor
2
Q
Every research study involving human subjects must be registered in a publicly accessible database
a) True
b) False
A
a) True
3
Q
The Declaration of Helsinki was developed by?
a) The Nuremberg tribunal
b) The World Medical Association
c) The government of Finland
d) The American Medical Association
A
b) The World Medical Association
4
Q
This phase determines therapeutic benefit and is usually done in a larger, specific population:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
A
c) Phase 3
5
Q
This phase begins after drug approval and explores therapeutic use:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
A
d) Phase 4
6
Q
This is the most typical study. investigates human pharmacology. it is the initial administration of an investigational new drug into humans. it is most commonly done in healthy subjects.
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
A
a) Phase 1
7
Q
Providing a unified standard for Europe, US and Japan to facilitate the acceptance of clinical trials is the:
a) Mission Statement of the ICH
b) Mission Statement of the Declaration of Helsinki
c) Mission Statement of the GCP Guidelines
d) Mission Statement of Canada Health
A
a) Mission Statement of the ICH
8
Q
An investigator can be defined as (Select all that can apply)
a) A person responsible for the conduct of the clinical trial with the sponsor
b) A person responsible for writing the clinical protocol
c) The responsible leader of the clinical research team at the site and may be called the principal investigator
d) A person responsible for the conduct of the clinical trial at that site
A
c) The responsible leader of the clinical research team at the site and may be called the principal investigator
d) A person responsible for the conduct of the clinical trial at that site
9
Q
A sub-investigator can be defined as:
a) The clinical research coordinator (CRC) or clinical trial nurse
b) Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make trial-related decisions
c) Any individual member of the clinical trial team supervised by the investigator at a trial site to perform trial-related procedures
d) Any individual member of the clinical trial team that performs trial related duties
A
b) Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make trial-related decisions
10
Q
A sponsor can be defined as:
a) An individual who both initiates and conducts, alone or with others, a clinical trial
b) An individual who participates in a trial
c) An individual or juridical or other body authorized under applicable law to consent to the subject’s participation in the clinical trial
d) An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing a clinical trial
A
d) An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing a clinical trial
11
Q
What is the purpose of ICH-GCP?
a. To standardize the design, conduct, recording, and reporting of clinical trials
b. To instruct clinicians as to how to conduct preclinical toxicology tests
c. To ensure that subjects are treated with the best available therapy
d. To increase the number of abbreviations used in clinical practice
A
a. To standardize the design, conduct, recording, and reporting of clinical trials
12
Q
What is the purpose of the IRB/IEC?
a. To help ensure that trials are
conducted according to the protocol
b. To monitor clinical trials
c. To design trial protocols
d. To protect subject safety
A
d. To protect subject safety
13
Q
According to ICH, the abbreviation ‘LAR’ stands for ‘Legally authorized Representative’.
A. True
b. False
A
A. True
14
Q
What is the minimum number of members on an IRB/IEC?
A. 3
b. 5
c. 7
d. 8
A
b. 5
15
Q
Who is responsible for providing the trial protocol?
A. The sponsor
b. The investigator
c. The IRB/IEC
d. The Institution
A
A. The sponsor
16
Q
What does ‘DSMB’ stand for?
A. Data Record Monitoring Board
b. Drug Statistics Measurement
Bureau
c. Drug Safety Monitoring Board
d. Data and Safety Monitoring Board
A
d. Data and Safety Monitoring Board
17
Q
In any trial, what should be the main concern of the physician?
A. The welfare of the subjects
b. Ensuring that the allotted quota of
subjects enrolled
c. The esteem that will be gained from a
successful trial outcome
d. The scientific outcome of the trial
A
A. The welfare of the subjects
18
Q
The World Medical Association (WMA) ethical principles for medical research involving
human subjects is called:
a. The International Research Act
b. The Belmont Report
c. The National Research Act
d. The Declaration of Helsinki
A
d. The Declaration of Helsinki
19
Q
The process by which a subject voluntarily confirms his or her willingness to participate in a
clinical trial is known as:
a. Intent to treat
b. Legally authorized agreement
c. Informed consent of trial subjects
d. IRB/IEC approval
A
c. Informed consent of trial subjects
20
Q
One of the primary purposes of a Phase I study is to:
a. Demonstrate long term safety and efficacy
b. Determine he metabolic and pharmacologic action of the drug in humans
c. Demonstrate efficacy within the established safe dose range
d. Gather information on additional indications for the drug
A
b. Determine he metabolic and pharmacologic action of the drug in humans
21
Q
What is the purpose of the ‘Data and Safety Monitoring Board (DSMB)’?
A. To approve the trial protocol
b. To ensure that the monitor is performing his/her duties correctly
c. To assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints
d. To ensure the accuracy of data and to carry out data analysis
A
c. To assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints
22
Q
What does the IRB/IEC evaluate? (select all that apply)
a. The subject-selection procedure
b. The rights, safety, and well-being of the subjects participating in the trial
c. The scientific tenability of the trial
d. The contract between the sponsor and investigator
A
a. The subject-selection procedure
b. The rights, safety, and well-being of the subjects participating in the trial
c. The scientific tenability of the trial
23
Q
Which of the following documents is the investigator obliged to comply with during the trial?
(select all that apply)
a. The sponsor’s desire to present the investigational product in the best possible light
b. All applicable laws and regulations
c. ICH-GCP
d. The trial protocol
A
b. All applicable laws and regulations
c. ICH-GCP
d. The trial protocol
24
Q
What is the purpose of the initiation visit? (Select all that apply)
a. To carry out source documentation verification
b. To review standard procedures
c. To review the blank Case Report Forms (crfs)
d. To review the protocol
A
b. To review standard procedures
c. To review the blank Case Report Forms (crfs)
d. To review the protocol
25
According to the principles of ICH GCP... (Select all that apply)
a. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against
the anticipated benefit for the individual trial subject and society.
A. trial should be initiated
and continued only of the anticipated benefits justify the risks.
B. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
C. Clinical trials should be conducted in accordance with the ethical principles that have origin in
the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory
requirements).
D. The available nonclinical and clinical information on an investigational product should be
adequate to support the proposed clinical trial.
A. trial should be initiated
and continued only of the anticipated benefits justify the risks.
B. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
C. Clinical trials should be conducted in accordance with the ethical principles that have origin in
the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory
requirements).
D. The available nonclinical and clinical information on an investigational product should be
adequate to support the proposed clinical trial.
26
Source data are...
A. Original documents, data, and records like hospital record and laboratory notes
b. Detailed, written instructions to achieve uniformity of the performance of a specific function
c. A written description of a change to or formal clarification of a protocol
d. All information in original records and certified copies of original records of the critical
findings, observations, or other activities in a clinical trial necessary for the reconstruction and
evaluation of the trial.
d. All information in original records and certified copies of original records of the critical
findings, observations, or other activities in a clinical trial necessary for the reconstruction and
evaluation of the trial.
27
A potential investigator usually only receives a protocol and Investigator's Brochure to
review from a sponsor:
a. After the protocol has been through initial IRB/IEC review
b. After an initial telephone conversation
c. After signing of a confidentiality agreement
d. After an initial visit has been made
c. After signing of a confidentiality agreement
28
Which of the following is NOT one of the required elements of an informed consent form?
A. A listing of all site personnel who will be involved in the research
b. The purpose of the research
c. A description of benefits that may be reasonable expected from the research
d. A contact person for questions about the research
A. A listing of all site personnel who will be involved in the research
29
Which of the following should the investigator do if a Serious Adverse Event (SAE) occurs?
(Select all that apply)
a. Inform the IRB/IEC, if required by local regulations
b. Discontinue the subject from the study
c. Report it to the monitor during the next study visit
d. Inform the sponsor immediately
a. Inform the IRB/IEC, if required by local regulations
d. Inform the sponsor immediately
30
After a Serious Adverse Event (SAE) has occurred, how should a subject identification occur on the immediate and follow-up reports?
A. By their subject identification number
b. By their address
c. By their name
d. By a unique code for serious Adverse Event (AE) reporting
A. By their subject identification number
31
In the event of a subject's death, what additional information should be supplied to the
sponsor? (Select all that apply)
a. Terminal medical reports, if available
b. The address of the next of kin so that the sponsor can write a letter of condolence
c. An autopsy report, if available
d. The name and address of the subject's general practitioner (GP)
A, C
32
32. What documentation should be supplied to the sponsor before the study? (Select all that
apply)
a. The cvs of all investigators and other study personnel who are significantly involved in trial
related duties
b. The signed contract between sponsor and investigator
c. The completed subject informed consent forms
d. The completed Case Report Form (CRF)
A, B
33
Who must sign the Informed Consent Form (ICF)? (Select all that apply)
a. The subject with the subject's legal representative (as applicable)
b. The monitor
c. A member of the IRB/IEC
d. The person who conducted the informed consent interview
A, D
34
34. Which of the following documents are required by the IRB/IEC before approval? (Select all
that apply)
a. Telephone script for patient recruitment
b. Clinical Trial Budget
c. Subject information leaflet
d. Study protocol
A, C, D
35
What details need to be documented in the subject notes when an Adverse Event (AE)
occurs? (Select all that apply)
a. What the subject thinks caused the
event
b. No documentation is necessary
c. The severity of the event
d. When the event occurred
C, D
36
Who is responsible for the appropriate monitoring of clinical trials?
A. The Sponsor
b. The Principal Investigator
c. The Contract Research
d. The IRB/IEC
A. The Sponsor
37
During the trial, who is responsible for communicating with the IRB/IEC?
A. The pharmacist
b. The sponsor
c. The monitor
d. The investigator
d. The investigator
38
Which of the following individuals could be members of an IRB/IEC? (Select all that apply)
a. The sponsor
b. Lay people
c. Trial Subjects
d. Medical professionals
b. Lay people
d. Medical professionals
39
In what format should approval be received from the IRB/IEC?
A. Electronic
b. Verbal
c. Personal
d. Written
d. Written
40
How can an Adverse Drug Reaction (ADR) be defined?
A. As an investigational drug that requires a second drug to be taken in order for the first one to be effective
b. As a noxious and unintended response to the investigational drug
c. As a positive response to the investigational drug
d. As an investigational drug that prevents any other drug from being effective
b. As a noxious and unintended response to the investigational drug
41
Which of the following would be most appropriate for Adverse Event (AE) reporting?
A. Telling subjects to only report Serious Adverse Events (saes)
b. Documenting and reporting all Adverse Events (aes). However trivial they may appear to be
c. Only documenting Adverse Events (aes) if more than one subject reports the event
d. Only informing subjects about the Serious Adverse Events (saes) that are likely to occur
b. Documenting and reporting all Adverse Events (aes). However trivial they may appear to be
42
Which of the following criteria is described in ICH-GCP as necessary for classifying an Adverse Event
(AE) as an Adverse Drug Reaction (ADR)?
A. That a causal relationship is at least a reasonable possibility
b. That a causal relationship is a definite possibility
c. That a causal relationship is a strong possibility
d. That a causal relationship is a very strong possibility
A. That a causal relationship is at least a reasonable possibility
43
What information needs to be included in the subject's medical records? (Select all that
apply)
a. Medical history
b. Occurrence of AE's
c. Randomization number
d. Name of the monitor
A, B, C
44
Which groups of potential subjects are mentioned in ICH-GCP as being 'vulnerable subjects'?
(Select all that apply)
a. Junior members of the medical profession
b. People with heart conditions
c. Employees of the pharmaceutical industry
d. Members of the armed forces
A, C, D
45
Who conducts clinical research Quality Control (QC) activities?
A. Investigator
b. Inspector
c. Monitor
d. Site staff
c. Monitor
46
According to the Declaration of Helsinki, physicians may use an unproven intervention.
A. True
B. False
A. True
47
What is the minimum amount of time after formal discontinuation of the clinical development of an
investigational product that essential documents should be retained according to ICH-GCP?
A. 16 years after the last marketing application approval in an ICH-GCP region
b. 4 years after the last marketing application approval in an ICH-GCP region
c. 2 years after the last marketing application approval in an ICH-GCP region
d. 8 years after the last marketing application approval in an ICH-GCP region
c. 2 years after the last marketing application approval in an ICH-GCP region
48
Medical research with a vulnerable group is only justified if the research is responsive to the health
needs or priorities of this group and it cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from
the research.
A. True
B. False
A. True
49
A candidate presents him/herself for a monitor position. What qualifications should the
potential monitor be able to provide proof of to be considered for the position?
A. Have the clinical knowledge needed to monitor a trial
b. Have the scientific knowledge needed to monitor a trial
c. Be familiar with GCP
d. A bachelor degree
A, B, C
50
A monitor is tasked to select investigators for a new upcoming oncology trial. What evidence of
qualifications should the potential investigator be able to provide to be considered for the conduct of
the trial? (Select all that apply)
a. A university degree
b. A log of training records of all trial specific training the investigator ever took
c. An up to date CV, showing evidence of adequate education, training and experience
d. Evidence of awareness of and compliance with GCP and the regulatory requirements
C, D
51
A subject visits the investigator at the scheduled visit window in her office as an outpatient and
reports he suffers from a fever after being treated by the Investigational Product (IP) for a week.
Is this occurrence an Adverse Event (AE) or a Serious Adverse Event (SAE)?
A. This is an SAE because the fever could be life-threatening, could result in death, could require
inpatient hospitalization or prolongation of hospitalization in case the subject was hospitalized,
could result in persistent significant disability/incapacity or is a congenital anomaly/birth defect.
B. This is an SAE because the fever could be related to the intake of the IP and could result in
hospitalization.
C. This is an AE because it can be classified as an untoward medical occurrence in a subject
administered a pharmaceutical product and which does not necessarily have a causal
relationship with this treatment.
C. This is an AE because it can be classified as an untoward medical occurrence in a subject
administered a pharmaceutical product and which does not necessarily have a causal
relationship with this treatment.
52
An experienced research coordinator was asked to train a new junior clinical trial team member on
safety reporting. What should she train on? (Select all that apply).
A. Report Unexpected Serious Adverse Drug Reactions (SUSARS) as per the applicable regulatory requirements.
B. Supply the IRB/IEC with a summary of all Adverse Events (aes) and Serious Adverse Events
(saes) on a monthly basis
c. All subjects should be identified by unique code numbers rather than by the subject's name.
D. Supply the sponsor and the IRB/IEC with any additional requested information for any
reported deaths.
A, C, D
53
When an Adverse Event (AE) occurs, why is it important for the investigator to have a list of
drugs that may or may not be permitted during the conduct of the trial?
A. To inform subjects
b. To avoid using contraindicated medication to treat the Adverse Event (AE)
c. As background information
d. To make sure the Adverse Event (AE) is not treated unintentionally
b. To avoid using contraindicated medication to treat the Adverse Event (AE)
54
Which of the following documents can ONLY be found in the sponsor's files?
A. Master randomization list
b. Investigator's brochure
c. Insurance statement
d. Signed agreement between the investigators
and the sponsor
A. Master randomization list
55
Data and Safety Monitoring Boards (dsmbs) have the power to recommend which of the following?
(Select all that apply)
a. That sponsor should stop the trial
b. That the sponsor should modify the trial
c. That the sponsor should continue the trial
d. That the sponsor should start a new trial
a. That sponsor should stop the trial
b. That the sponsor should modify the trial
c. That the sponsor should continue the trial
56
How can expected Adverse Events (aes) be described?
A. Those that are can be seen in every day practice
b. Those that have been reported in previous clinical or preclinical trials
c. Those that are consistent with the applicable product information
d. Those that aren't serious
b. Those that have been reported in previous clinical or preclinical trials
c. Those that are consistent with the applicable product information
57
Who is permitted to enter data into the case report form? (Select all that apply)
a. The investigator
b. The subject
c. The sponsor
d. Any person delegated by the investigator to carry out this task, as documented
a. The investigator
d. Any person delegated by the investigator to carry out this task, as documented
58
Which of the following documents is only filed in the investigator's files?
A. Serious Adverse Event (SAE) forms
b. IRB/IEC approval
c. The investigator's (IB) brochure
d. Signed informed consent forms
d. Signed informed consent forms
59
When is verbal consent prior to participation in a research study permitted?
A. When the subject is illiterate
b. When the subject has a Legally
Acceptable Representative (LAR)
c. When the study has minimal risk
d. When the study has more than minimal risk
A. When the subject is illiterate
60
What will be reviewed during an audit? (Select all that apply)
a. Procedures for reporting Serious
Adverse Events (saes)
b. Informed consent procedures
c. The accounts of the hospital/research unit
d. Adherence to protocol
a. Procedures for reporting Serious
Adverse Events (saes)
b. Informed consent procedures
d. Adherence to protocol
61
In which of the following instances is it necessary to contact the IRB/IEC?
A. When a subject is found to be
noncompliant with the trial medication
b. When a Serious, Unexpected Adverse
Drug Reaction (sadrs) occurs
c. Each time a new subject is enrolled
d. If the investigator does not complete
enrollment
b. When a Serious, Unexpected Adverse
Drug Reaction (sadrs) occurs
62
62. Which signatures are required by ICH Guidelines to be on the Informed Consent Form (ICF)?
A. The investigator
b. The person who conducted the informed
consent discussion
c. The investigator and the subject
d. The subject
b. The person who conducted the informed
consent discussion
d. The subject
63
63. Whose responsibility is it to safeguard the rights and safety of subjects in clinical trials?
(Select all that apply)
a. The investigator
b. The sponsor
c. The IRB/IEC
d. The subjects' general practitioner (GP)
a. The investigator
b. The sponsor
c. The IRB/IEC
64
64. Which hospital personnel are normally directly involved in a clinical trial? (Select all that
apply)
a. Research nurses
b. The sponsor
c. Pharmacists
d. Hospital orderlies
a. Research nurses
c. Pharmacists
65
65. Who does the investigator need to inform if he/she deviates from the protocol? (Select all
that apply)
a. The sponsor
b. The regulatory authorities
c. The office staff
d. The IRB/IEC
a. The sponsor
b. The regulatory authorities
d. The IRB/IEC
66
66. Who should have access to the trial files?
(Select all that apply)
a. The subject
b. The monitor
c. The investigator
d. The pharmacist
b. The monitor
c. The investigator
67
67. An Adverse Event (AE) that is severe in intensity:
a. Is always classified as serious
b. Is never classified as serious
c. May not meet the definition of serious
d. Should be submitted to the sponsor within
24 hours
c. May not meet the definition of serious
68
68. Which of the following is always true?
A. Adverse Drug Reactions (adrs) are evidence that the drug is working
b. An Adverse Drug Reaction (ADR) is an Adverse Event (AE)
c. An Adverse Event (AE) is an Adverse Drug Reaction (ADR)
d. Adverse Events (aes) are less frequently observed in placebo arms.
b. An Adverse Drug Reaction (ADR) is an Adverse Event (AE)
69
69. Which of the following tasks is the investigator responsible for? (Select all that apply)
a. Treating the subject if an Adverse Event (AE) occurs in the case the investigator is a qualified
physician or dentist
b. Make reasonable efforts to ascertain the reasons for a subject's premature withdrawal from the
trial
c. Encouraging subjects to report all Adverse Events (aes)
d. Upon permission of the subject, inform primary physician of subject's participation in the trial
A, b, c, d
70
70. Why is it a good idea to develop standard procedures? (Select all that apply)
a. To assign responsibility
b. To promote compliance
c. To ensure that the trial is run consistently
d. To practice logical thinking skills
a. To assign responsibility
b. To promote compliance
c. To ensure that the trial is run consistently
71
71. What topics are discussed during the pre-trial visit? (Select all that apply)
a. Laboratory requirements
b. Availability of subjects
c. Competing studies
d. Sponsor expectations
A, b, c, d
72
72. How should any leftover investigational product be disposed?
A. It should always be returned to the sponsor company
b. It should always be incinerated at the hospital
c. It should always be disposed of by the monitor, as this is one of his/her key responsibilities
d. It should be disposed of according to an agreed-to-procedure arranged before the start of the
study
d. It should be disposed of according to an agreed-to-procedure arranged before the start of the
study
73
73. During a monitoring visit, it was discovered that a new clinical research coordinator had been
hired and assigned to an ongoing study. What actions must be taken by the monitor? (Select all that
apply)
a. Ensure that the coordinator's name is on
the delegation of duties log
b. Conduct a background check
c. Train the coordinator in GCP and
protocol
d. Verify coordinator's training and
qualifications
a. Ensure that the coordinator's name is on
the delegation of duties log
d. Verify coordinator's training and
qualifications
74
74. Design in which subjects are randomized to one of two or more arms, each arm being allocated a
different treatment. These treatments will include their investigational product at one or more
doses, and one or more control treatments, such as placebo and/or an active comparator.
A. Crossover design
b. Adaptive design
c. Parallel design
d. Randomized design
c. Parallel design
75
75. The clinical trial design in which each subject is randomized to a sequence of two or more
treatments and hence acts as his own control for treatment comparisons.
A. Crossover design
b. Adaptive design
c. Parallel design
d. Randomized design
A. Crossover design
76
76. A subject in its third trial week in an oncology trial at a hospital site asks the investigator
during a follow-up visit for some clarifications on the Investigational Product (IP) dosage used. The
investigator refers the subject to the pharmacist for more information as (s)he claims not to know the details
of how to use the IP. Is this answer in compliance with the GCP E6 guideline?
A. Yes. The pharmacist is responsible for all IP related duties and questions if this task was
delegated to the pharmacist and the delegation of duties form was completed by the investigator
at the start of the trial.
B. Yes. The responsibility for the IP handling is automatically handed over from the investigator
to
the pharmacist when a trial is conducted at a site that is situated in a hospital that has its own
internal pharmacy. The pharmacist should instruct the subject and check periodically for
understanding/compliance
c. No
D
D
77
77. A monitor has discovered that an investigational product was stored in a room affected by a
power outage over a weekend. The temperature log reflects that the room temperature dropped to
45of/7oc on Sunday. All investigational products must be stored at temperatures between 59 and 77of (15
and 25oc). What action should the monitor take? (Select all that apply)
a. Record the temperature excursion in the morning report. No further action would be needed
since the room did not reach freezing temperature.
B. Contact the sponsor to report the excursion and determine the next course of action regarding
the use of investigational products at the site.
C. Return all investigational products stored in that room to the sponsor and request a new
shipment.
D. Document the temperature excursion in the monitoring report and assist the site with a
corrective and preventative action.
B. Contact the sponsor to report the excursion and determine the next course of action regarding
the use of investigational products at the site.
D. Document the temperature excursion in the monitoring report and assist the site with a
corrective and preventative action.
78
78. An investigator is confronted with a life-threatening situation that necessitates using a test article in a
human subject who is unable to provide informed consent and there is no time to obtain consent
from the individual's legal representative. Which of the following describes the best course of action
for the investigator?
A. Sign the consent form on behalf of the subject and use the test article
b. Enroll the subject per required measures described in the protocol, with documented approval/favorable opinion by the IRB/IEC. The subject's legally acceptable representative should be informed as soon as possible to continue consent.
C. Do not use the test article until either the subject or the subject's legally acceptable
representative
can give consent.
D. Call the IRB/IEC and ask for an exemption.
b. Enroll the subject per required measures described in the protocol, with documented approval/favorable opinion by the IRB/IEC. The subject's legally acceptable representative should be informed as soon as possible to continue consent.
79
79. A subject, who has been 100% compliant this far, has forgotten to bring her medication back
to the clinic for her regular visit. She reports that she has not missed any doses and has been fully
compliant with the protocol. What is the most appropriate action for the investigator/clinical
research coordinator to take?
A. Contact the sponsor to report the protocol deviation
b. Document that the subject has forgotten to return her medication in the source document and ask her to bring the medication back to the clinic as soon as possible or at her next visit.
C. Record nothing in the source document or in the product accountability log.
D. Record no missed doses in the source document and in the investigational product accountability log.
b. Document that the subject has forgotten to return her medication in the source document and ask her to bring the medication back to the clinic as soon as possible or at her next visit
80
80. If the investigator becomes ill during the trial, what will happen to the study?
A. The monitor will take over the running of the study until the investigator returns.
B. A "second-in-command" (appointed before the start of the study) will take over the running of
the study until the investigator returns.
C. The study will be put on hold until the investigator is sufficiently well to return to work.
D. This study will be postponed for one month (or a period prearranged with the sponsor). After
this period, if the investigator is still ill, a fellow member of the team will be appointed investigator.
B. A "second-in-command" (appointed before the start of the study) will take over the running of
the study until the investigator returns.
81
81. The subject arrives for the informed consent interview, but the investigator has no more
informed consent forms. What should the investigator do? (Select all that apply)
a. Write the details on a blank piece of paper
b. Ask the subject to come back
c. Have already made sure that there were enough forms before the interview
d. Photocopy another subject's form and use correction fluid to remove the details
b. Ask the subject to come back
c. Have already made sure that there were enough forms before the interview
82
82. What action should be taken if the protocol is altered during the trial? (Select all that apply)
a. The trial must begin again.
B. The subject should be asked to re-consent if alterations to the protocol could affect their
willingness to participate.
C. The sponsor must dismiss the investigator.
D. The IRB/IEC should be informed and approve the changes if the trial is to continue.
B. The subject should be asked to re-consent if alterations to the protocol could affect their
willingness to participate.
D. The IRB/IEC should be informed and approve the changes if the trial is to continue.
83
83. A site has been notified it will be inspected. What is the best way to ensure that the site is adequately
prepared?
A. Complete any incomplete forms with any relevant information the investigator can remember.
B. Comply with ICH-GCP guidelines and protocol requirements throughout the study.
C. Ensure that everything is tidy.
D. Cover up any shortcomings where the investigator thinks inspectors will reveal serious
findings.
B. Comply with ICH-GCP guidelines and protocol requirements throughout the study.
84
84. A site is being renovated and no longer has adequate storage space to hold all of the past studies it has conducted. Some studies are older than 20 years. Some Investigational Products (ips) are now
marketed. How can the site determine which files it still needs to store?
A. Contact the sponsor for each trial to ask for a letter outlining instructions for disposition of
records.
B. Dispose of studies who products are now marketed in the U.S. for at least 2 years.
C. Contact the sponsor for the files the site no longer can store and ask them to store the records.
D. Dispose of any studies older than 20 years since patent has expired.
A. Contact the sponsor for each trial to ask for a letter outlining instructions for disposition of
records.
85
85. A non-English speaking subject has responded to a recruitment ad to participate in a trial for treatment of her diabetes. She arrives at the site with her daughter who is fluent in English. The informed consent forms are only available in English. What actions are compliant with GCP?
A. Find a member of the clinic staff who speaks the same language as the subject to serve as the
interpreter.
B. Contact the IRB/IEC and ask for an exemption to screen subject.
C. Call the sponsor to request a translation of the informed consent.
D. Ask the subject's daughter to serve as interpreter and read the consent form to the subject.
C. Call the sponsor to request a translation of the informed consent.
86
86. The investigator at a big research center asked the monitor to complete the drug accountability forms
as the site staff was not able to complete this on time before the Quality Control (QC) visit of the monitor. How should the monitor respond best?
A. The monitor should not respond and ask advice from their manager on how to act.
B. The monitor should refuse kindly and ask the site staff to complete the drug accountability
forms.
C. The monitor should do as the investigator asks because the investigator is the leader of the
trial.
D. The monitor should suggest to collaborate with the site staff and complete the drug
accountability
forms together at the occasion of the site visit.
B. The monitor should refuse kindly and ask the site staff to complete the drug accountability
forms.
87
87. An investigator is willing to lead the conduct of a clinical trial if the sponsor allows deviations from the
protocol to accommodate the trial subjects. How should the sponsor react to this request?
A. The sponsor should refuse this request as no protocol changes are ever allowed.
B. The sponsor should state that each request would need to be considered for a possible
amendment prior to allowing any deviations.
C. The sponsor should ask the local regulatory bodies for advice.
D. The sponsor should allow this as the investigator is responsible for trial conduct.
B
B. The sponsor should state that each request would need to be considered for a possible
88
88. During a routine monitoring visit the monitor finds out the Informed Consent Form (ICF) of one of the
subjects enrolled in the trial was NOT personally dated by the subject. What is the BEST corrective
action to be taken by the monitor?
A. The monitor should leave as is and make a note of it in the monitoring visit report.
B. The monitor should ask the site staff to inform the IRB/IEC of the error.
C. The monitor should ask the site staff to discuss the issue with the subject and document the
discussion in the source documents.
D. The monitor should ask the site staff to take action and have the subject date personally and
provide an explanation of the change on the original ICF.
D. The monitor should ask the site staff to take action and have the subject date personally and
provide an explanation of the change on the original ICF.
89
89. A Clinical Research Coordinator (CRC) adjusted the dose of the Investigational Product (IP)
for subject as the subject was suffering from Adverse Events (AEs) like headaches and vomiting.
When is a CRC allowed to do this task?
A. Only when the CRC is a qualified physician
B. Only under the supervision of another site staff member who is named on the signature and delegation log
C. Never
D. Always; patient safety comes first
A. Only when the CRC is a qualified physician
90
90. A monitor is making corrections on the Case Report Form (CRF) during a monitoring visit and asks
the site staff (as identified on the signature and delegation log) to sign and date these corrections.
This is an accepted way of working because:
a. Anybody can complete the CRF
b. The sponsor is ultimately responsible for the quality of the trial data and the investigator only
needs to document the corrections.
C. It does not matter who makes the corrections on the CRF (sponsor representatives or its staff identified on the signature and delegation log) as long as they are made, when necessary, endorsed by the investigator, and documented.
D. The monitor is best suited to make those changes because he/she is considered the experts on
the protocol.
C. It does not matter who makes the corrections on the CRF (sponsor representatives or its staff identified on the signature and delegation log) as long as they are made, when necessary, endorsed by the investigator, and documented.
91
91. In general, unused investigational drugs:
a. Can be kept for the next study
b. Can be destroyed by the investigator or
pharmacy
c. Can be re-dispensed by the pharmacy
d. Must be returned to the sponsor
d. Must be returned to the sponsor
92
92. How long is the follow up period for subjects after Adverse Events (aes)?
A. One year
b. It is specified in the protocol
c. Two years
d. Six months
b. It is specified in the protocol
93
93. Which of the following statements would be unacceptable in a consent form?
A. In the event of any injury related to this research, you will be given medical treatment.
B. I waive any possibility of compensation for injuries that I may receive as a result of participation in
this research.
C. Your participation in this research is voluntary. If you choose not to participate but change your
mind later, your decision will not affect your relationship with your doctor.
D. The investigator may stop you from participating in this research without your consent if you
experience side effects that make your condition worse.
B. I waive any possibility of compensation for injuries that I may receive as a result of participation in
this research.
94
94. What should be done in case of inability to provide the relevant data for a requested piece of
information on the Case Report Form (CRF)?
A. Enter 'N/A' (Not Applicable)
b. Take the average of the previous two
readings
c. Document why the information cannot be
provided
d. Nothing
c. Document why the information cannot be
provided
95
95. Who should provide for the cost of treatment of trial subjects in the event of trial-related injuries?
A. The sponsor
b. The clinician
c. The subject
d. The pharmacist
A. The sponsor
96
96. If a piece of equipment required for use during the trial is out of order, what should the
investigator do?
A. Wait for the instrument to be repaired.
B. Have already-made contingency plans for back-up equipment before the trial started.
C. Inform the monitor and ask him/her to find another instrument that will perform the same
task.
D. Exclude any tests performed using this equipment from that point onwards.
B. Have already-made contingency plans for back-up equipment before the trial started.
97
97. Before the trial begins, what tasks should be undertaken with the pharmacist with regard to
trial medication? (Select all that apply)
a. The investigator should inform the pharmacist as to how to package and label materials.
B. The pharmacist should remove any medication that could be confused with the trial
medication
from the pharmacy.
C. The pharmacist should be informed as to when medication will arrive and how it will need to
be stored.
D. The investigator should show the pharmacist all the drug accountability documentation that
will be used in trial.
a. The investigator should inform the pharmacist as to how to package and label materials.
medication
from the pharmacy.
C. The pharmacist should be informed as to when medication will arrive and how it will need to
be stored.
be stored.
D. The investigator should show the pharmacist all the drug accountability documentation that
will be used in trial.
98
98. What type of document is the Case Report Form (CRF)?
A. A source document
b. A superfluous document
c. A non-essential document
d. An essential document that can also be a source document
d. An essential document that can also be a source document
99
99. Failing to meet recruitment expectations can lead to problems in which of the following areas? (Select
all that apply)
a. Statistical analysis
b. Delays in the product reaching patients
c. Source Data Verification (SDV)
d. Subject compliance
a. Statistical analysis
b. Delays in the product reaching patients
100
100. During the conduct of a trial an investigator receives updated Investigator's Brochures (IB's)
from the sponsor. The investigator never forwards a copy to the IRB/IEC as (s)he claims this is not
needed because the IB was sent to the IRB/IEC and the trial was approved in writing by the IRB/IEC
before the trial started. Is this a correct statement?
A. Yes. Sending an updated IB to the IRB/IEC is not a GCP requirement.
B. Yes. The updates to the IB are mostly administrative in nature so patient safety is
safeguarded.
C. No. The investigator can decide on a case per case basis to supply the IRB/IEC with a copy of
the IB or not. In the event of a safety issue, the investigator must provide the IRB/IEC with a
copy.
D. No. The investigator should supply a copy of the updated IB to the IRB/IEC.
D. No. The investigator should supply a copy of the updated IB to the IRB/IEC.
101
Belmont Report (1979)
CORRECT ANSWER
Ethical principles and guidelines for the
protection of human subjects of research.
102
Respect for persons
CORRECT ANSWER
Individuals should be treated as autonomous agents
and persons with diminished autonomy are entitled to protection.
103
An autonomous person
CORRECT ANSWER
A person capable of deliberation about personal
goals and of acting under the direction of such deliberation
104
Beneficences
CORRECT ANSWER
Do not harm and maximize possible benefits and minimize possible harm.
105
Justice
CORRECT ANSWER
Whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide
advantages only to those who can afford them and that such research should not unduly involve
persons from groups unlikely to be among the beneficiaries of subsequent applications of the
research.
106
Three elements of the consent process
CORRECT ANSWER
Information, comprehension, voluntariness.
107
What is an example of how the principle of beneficence can be applied to a study employing
human subjects
CORRECT ANSWER
Determining the study has a maximization of benefits and a minimization of risks
108
What are the three principles discussed in the Belmont Report?
CORRECT ANSWER
Respect for persons, beneficence, justice
109
The Belmont Report's principle of respect for persons incorporates at least 2 ethical convictions:
first, that individuals should be treated as autonomous agents, and second, that:
CORRECT ANSWER
Persons with diminished autonomy are entitled to protection
