knowledge

Question 1

What are original documents, data and records about a subject in a clinical trial captured in?

a.Case Report Forms

b.Medical Records

c.Source Documents

d.Essential Documents

Answer 1

Source Documents

Question 2

The Declaration of Helsinki states that “Measures to minimise the risks must be implemented”. In doing so, the risks must be continuously _______________, _______________, and _______________ by the researcher. (Indicate the correct order of the principles):

This question should have a single correct answer
Question 31Answer

a. Minimized, Audited, and Recorded

b. Monitored, Assessed, and Documented

c. Managed, Assessed, and Recorded

Question 3

In general, which ranks higher when conducting clinical trials?

Answer 3

Local Laws, Directives, or Regulations

Question 4

One benefit of transparent reporting of trial results is that it enables the reader to judge the reliability and validity of trial results.

True
False

Answer 4

True

Question 5

Deviations from standard medical practice are considered research.

True
False

Answer 5

False

Question 6

Elements of a clinical research protocol include all but which of the following?

1. Study rationale
2. Research objectives
3. Study Design description
4. Selection and withdrawal of subjects
5. Requirements for ethical approval and oversight
6. Statistical analysis description

Answer 6

Requirements for ethical approval and oversight

Question 7

Clinical equipoise is considered to be a necessary feature for the ethical enrollment of participants into a clinical trial.

True
False

Answer 7

True

Question 8

All of the following are key roles or entities involved in clinical trials EXCEPT which?

a. The Principal Investigator
b. The Clinical Research Associate (CRA)
c. The Sponsor
d. The Contract Research Organization (CRO)
e. The Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
f. The Patient Advocate
g. The Clinical Research Coordinator (CRC)
h. The Indpendent Data-Monitoring Committee (EDMC) or Data Safety Management Board (DSMB)
i. Regulatory Authorities

Answer 8

The Patient Advocate

Question 9

How should the statistical analysis plan be developed?

a. Prospectively, in conjunction with the protocol

b. Retrospectively, once the study has been completed

c. At the discretion of the Sponsor

Answer 9

Prospectively, in conjunction with the protocol

Question 10

Which is true of enrolling subjects who fail to meet all eligibility criteria?

a. Puts subject safety at risk
b. Compromises the ability to pool the data for analysis
c. Confounds the interpretation of results
d. Violates the principles outlined in the Declaration of Helsinki
e. All of the above
f. A, B and C only

Answer 10

Violates the principles outlined in the Declaration of Helsinki

Question 11

According to local low, Investigators should immediately report SAEs to the sponsors and IRB/IEC followed by detailed written reports within a timely fashion.

True
False

Answer 11

True

Question 12

How can data quality assurance be ensured?

a. Training of study personnel
b. Monitoring of investigators by sponsor/CRO personnel
c. Instruction manuals
d. Data verification
e. Centralized testing (e.g., labs, ECG readings)
f. All of the above
g. B and D only

Answer 12

All of the above

Question 13

Which of the following documents has/have influenced the ethical principles within the current GCP guidelines?

a. The Nuremberg Code
b. The Declaration of Helsinki
c. The Paris Report
d. A and B

Answer 13

d. A and B

Question 14

As part of their risk assessment process the sponsor determines that there is a high likelihood that enrollment in the trial will be challenging and slow. Which of the following is the best choice in this situation:

a. The sponsor should develop a risk management plan to handle this operational risk
b. The sponsor should develop a proactive recruitment strategy to mitigate the risk of low enrollment
c. The sponsor should outsource the trial to a CRO to ensure enrollment success
d. All of the above
e. A and B only

Answer 14

e. A and B only

Question 15

Use of alternate modalities of obtaining informed consent or assent such as use of videos, quizzes to gauge comprehension, requiring witness signatures or requiring more than just the subject to sign consent are examples of additional protections that may be in place to safeguard vulnerable populations.

True
False

Answer 15

True

Question 16

When critically analyzing study results, the reader may find flaws or limitations in which of the following areas?

Select one or more:

A. Limitations due to the sample size of the population
B. Lack of objectivity or presence of bias in the design of the study or interpretation of the results
C. Methodological issues in terms of study design
D. Lack of generalizability or applicability of the results

Answer 16

Limitations due to the sample size of the population

Lack of objectivity or presence of bias in the design of the study or interpretation of the results

Question 17

True or false? Direct communication between a sponsor and IRB/IEC is expressly prohibited per GCP.

Question 15Select one:
True
False

Answer 17

False

Question 18

Which of the following is NOT considered part of the definition of an SAE:

a.Results in death
b.Is a life-threatening event
c.Results in a visit to the emergency room/emergency department
d.Requires inpatient hospitalization or prolongation of hospitalization
e.Results in persistent or significant disability/incapacity
f.Is a congenital anomaly or birth defect

Answer 18

Results in a visit to the emergency room/emergency department

Question 19

What is true of an impartial witness?

This question should have a single correct answer

Question 17Answer

a.
Should always be present during the informed consent process

b.
Is required during the informed consent process for all vulnerable subjects

c.
Should attend the informed consent process if the subject or their legally acceptable representative cannot read

d.
Should be independent of the trial

e.
All of the above

f.
C and D only

Answer 19

C and D only

Question 20

Choose the best answer for this statement. Relevant communication between the sponsor/CRO and investigative sites should be documented.

Question 18Answer

a.
True

b.
False

c.
It depends if this expectation is documented within the sponsor’s SOPs or not

Answer 20

True

Question 21

All but which of the following have the authority to terminate a clinical trial for the entire study or at a given site?

a. The sponsor
b. The CRO
c. The IRB or IEC
d. The PI
e. The IDMC or DSMB
f. The Regulatory Authorities
g. B and E

Answer 21

g. B and E

Question 22

What is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), GCP, and the applicable regulatory requirements known as?

Question 20Answer

a.
Source data verification

b.
Auditing

c.
Monitoring

d.
Study coordinating

e.
Risk management and oversight

Question 23

One important distinction between standard of care medical treatment and clinical research is that the intent of medical treatment is to address the needs of an individual patient in the here and now, whereas clinical research is intended to answer questions about whether a treatment or procedure could benefit large groups of people in the future?

True
False

Answer 23

True

Question 24

As part of a risk-based quality management approach, ICH GCP E6 (R2) guidelines recommend that all of the following be included as risk control measures EXCEPT what?

This question should have a single correct answer

Question 22Answer

a.
That the sponsor determines which risks to accept or reduce

b.
That pre-defined quality tolerance limits (QLTs) are established

c.
That quality tolerance limits (QLTs) are determined on an as needed basis

d.
That deviations from QLTs should trigger an evaluation to determine if further action is needed

Answer 24

That quality tolerance limits (QLTs) are determined on an as needed basis

Question 25

When a potential subject confuses the research study for a proven treatment, this is known as what? a. Therapeutic misconception b. Clinical equipoise c. The participant's dilemma d. The uncertainty principle

Answer 25

Therapeutic misconception

Question 26

Choose the most appropriate answer for this statement. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s). a. True b. False c. It depends on the level of risk associated with the trial

Answer 26

True

Question 27

What are original documents, data and records about a subject in a clinical trial captured in? a. Case Report Forms b. Medical Records c. Source Documents d. Essential Documents

Answer 27

Source Documents

Question 28

True or false? The monitor or Clinical Research Associate (CRA) should correct data in the CRF after discussion with the investigator. True False

Answer 28

False

Question 29

The investigational new drug development process consists of which of the following? a. Pre-clinical testing, 2 phases of clinical trials and regulatory submission, review and approval of the marketing application b. Pre-clinical testing, 3 phases of clinical trials and regulatory submission, review and approval of the marketing application c. Pre-clinical testing, 4 phases of clinical trials and regulatory submission, review and approval of the marketing application d. Pre-clinical testing, 5 phases of clinical trials and regulatory submission, review and approval of the marketing application

Answer 29

Pre-clinical testing, 4 phases of clinical trials and regulatory submission, review and approval of the marketing application

Question 30

Who determines the nature and extent of monitoring that should be performed for a given trial? a. The sponsor b. The CRO c. The Regulatory Authorities d. The IRB/IEC e. All of the above

Answer 30

The sponsor

Question 31

Which of the following is an influential document that led to the evolution of informed consent practices? a. The Nuremberg Code b. The Declaration of Helsinki c. The Belmont Report d. all of the above

Answer 31

all of the above

Question 32

The conduct of a sponsor's audit should be what? a. Independent of, and separate from routine monitoring or quality control functions b. To evaluate trial conduct and compliance with the protocol, SOPs, GCPs and the applicable regulatory requirements c. Performed by individuals who are independent of the trial d. Done a minimum of every six months e. All of the above f. A, B and C only

Answer 32

A, B and C only

Question 33

A monitor (CRA) is reviewing source documents at an investigative site and finds blood pressure recorded for a subject visit in a photocopy of the medical records for the day of the subject's visit. Which of the source document ALCOA-C principles is in conflict in this scenario? a. Attributable b. Legible c. Contemporaneous d. Original e. Accurate f. Complete

Answer 33

Original

Question 34

All of the following are examples of documents and reports that are required in the context of clinical trial conduct EXCEPT which? a. Monitoring visits reports b. Expedited safety reports c. Reports documenting communications between sponsors and sites (e.g., letters, written communications) d. Case Report Forms e. Patient status, recruitment and query reports f. Curriculum Vitae's for all site personnel g. Protocol deviation reports to IRBs/IECs

Question 35

All of the following are elements or principles of human subject protection EXCEPT a. Voluntary, informed consent b. Respect for persons: treated as autonomous agents c. The right to end participation in research at any time d. Right to safeguard integrity e. Benefits should outweigh risk f. Protection from physical, mental, and emotional harm g. The primary care physician can overrule the subject's decision to participate in a trial h. Access to information regarding research i. Protection of privacy and well-being

Answer 35

The primary care physician can overrule the subject's decision to participate in a trial

Question 36

The nature and level of risk in a clinical trial could impact which of the following? This question should have a single correct answer Question 36Answer a. Whether or not informed consent is required for the trial b. Whether the IRB/IEC may review the progress of the trial more frequently than every year c. Whether the sponsor conducts any monitoring of the trial d. All of the above

Answer 36

Whether the IRB/IEC may review the progress of the trial more frequently than every year

Question 37

Why are vulnerable populations named as such? This question should have a single correct answer Question 37Answer a. May be vulnerable to undue influence or coercion b. Have limited comprehension or ability to understand information c. Could likely bias the results of the research d. All of the above e. A and B only

Question 38

The primary purpose(s) of monitoring is/are to verify what? This question should have a single correct answer Question 38Answer a. The rights and well-being of human subjects are protected b. The reported trial data are accurate, complete, and verifiable from source documents c. The conduct of the trial is in compliance with the protocol, GCP and applicable regulatory requirements d. That all risks to human subjects have been minimized e. All of the above f. A, B and C only

Question 39

True or false? Any materials used for the purpose of recruitment subjects (e.g., advertisements, written information to be provided to subjects or any other subject-facing materials) should be reviewed and approved by the IRB/IEC prior to use: Question 39Select one: True False

Answer 39

True

Question 40

All of the following are examples of safeguards to protect human subjects in clinical trials EXCEPT This question should have a single correct answer a. Ethics approval of clinical trials b. Adequate financial compensation for trial participation c. Data safety monitoring boards d. Audits and inspections by sponsors and regulatory agencies e. Principal investigator qualifications f. Patient privacy policies and guidelines g. Subjects bill of rights

Answer 40

Adequate financial compensation for trial participation

Question 41

The terms auditing and monitoring can be used interchangeably and as long as one is performed during the conduct of a trial, it is not necessary to do the other. This question should have a single correct answer Question 41Select one: True False

Answer 41

False

Question 42

A planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants is called what? This question should have a single correct answer Question 42Select one: 1. An outcome measure 2. A primary objective 3. A hypothesis 4. None of the above

Question 43

In considering whether or not to approve a clinical trial, the IRB/IEC should consider the qualifications of the investigator via review of a current curriculum vitae or other documentation. This question should have a single correct answer Question 43Answer a. True b. False c. It depends - only if the IRB/IEC hasn't worked with the investigator in the past

Question 44

In almost all situations, research needs trump or prevail over an individual's basic privacy rights. This question should have a single correct answer Question 44Select one: True False

Question 45

Who are the primary stakeholders involved in approving clinical trials, at the site or overall study level? Question 45Answer a. The sponsor b. The CRO c. The IRB or IEC d. The PI e. The IDMC or DSMB f. The Regulatory Authorities g. All of the above h. A, C, D, and F only

Question 46

Generally speaking, sponsors must report SUSARs (Serious Suspected Unexpected Serious Adverse Reactions) to the regulatory authorities within 5 days (if a death or life-threatening event) or within 10 days for all other SUSARs. This question should have a single correct answer Question 46Select one: True False

Question 47

The Declaration of Helsinki states that "Measures to minimise the risks must be implemented". In doing so, the risks must be continuously _______________, _______________, and _______________ by the researcher. (Indicate the correct order of the principles): a. Minimized, Audited, and Recorded b. Monitored, Assessed, and Documented c. Managed, Assessed, and Recorded

Answer 47

Monitored, Assessed, and Documented

Question 48

According to GCPs, which of the following methods best ensure transparency and allow for the reconstruction of the course of events taking place in a clinical trial? a. Audit Trail b. Source Document Verification c. Trial Master Files d. Case Report Forms e. None of the above

Question 49

Per the protocol, an ECG should be performed at Visit 2. At site #A123, subject A-102 missed the visit due to a winter storm. The appointment was rescheduled for a week later, although this was out of the protocol visit window, and the ECG was performed at that time and revealed no abnormalities. What is this an example of? a. A major protocol deviation b. A preventable protocol deviation c. Serious misconduct but no protocol deviation d. A protocol deviation that should be addressed via a note to file and retraining e. A protocol deviation that should be documented f. A protocol deviation that should be reported to the IRB/IEC

Answer 49

A protocol deviation that should be documented

Question 50

According to GCPs, which of the following parties determines the temperature requirements and storage conditions for investigational products to ensure they are adequate and controlled during the clinical trial: a. The regulatory authority b. The sponsor c. The CRO d. The IRB/IEC e. The Investigator

Answer 50

The sponsor

Question 51

Use of alternate modalities of obtaining informed consent or assent such as use of videos, quizzes to gauge comprehension, requiring witness signatures or requiring more than just the subject to sign consent are examples of additional protections that may be in place to safeguard vulnerable populations. True False

Question 52

All of the following are elements or principles of human subject protection EXCEPT This question should have a single correct answer a. Voluntary, informed consent b. Respect for persons: treated as autonomous agents c. The right to end participation in research at any time d. Right to safeguard integrity e. Benefits should outweigh risk f. Protection from physical, mental, and emotional harm g. The primary care physician can overrule the subject's decision to participate in a trial h. Access to information regarding research i. Protection of privacy and well-being

Question 53

All of the following are examples of safeguards to protect human subjects in clinical trials EXCEPT This question should have a single correct answer Question 34Answer a. Ethics approval of clinical trials b. Adequate financial compensation for trial participation c. Data safety monitoring boards d. Audits and inspections by sponsors and regulatory agencies e. Principal investigator qualifications f. Patient privacy policies and guidelines g. Subjects bill of rights

Question 54

One benefit of transparent reporting of trial results is that it enables the reader to judge the reliability and validity of trial results. Question 35Select one: True False

Question 55

True or false? Direct communication between a sponsor and IRB/IEC is expressly prohibited per GCP. Question 36Select one: True False

Question 56

How can data quality assurance be ensured? This question should have a single correct answer Question 38Answer a. Training of study personnel b. Monitoring of investigators by sponsor/CRO personnel c. Instruction manuals d. Data verification e. Centralized testing (e.g., labs, ECG readings) f. All of the above g. B and D only

Question 57

Which is true of enrolling subjects who fail to meet all eligibility criteria? This question should have a single correct answer Question 39Answer a. Puts subject safety at risk b. Compromises the ability to pool the data for analysis c. Confounds the interpretation of results d. Violates the principles outlined in the Declaration of Helsinki e. All of the above f. A, B and C only

Question 58

Per the protocol, an ECG should be performed at Visit 2. At site #A123, subject A-102 missed the visit due to a winter storm. The appointment was rescheduled for a week later, although this was out of the protocol visit window, and the ECG was performed at that time and revealed no abnormalities. What is this an example of? This question should have a single correct answer Question 40Answer a. A major protocol deviation b. A preventable protocol deviation c. Serious misconduct but no protocol deviation d. A protocol deviation that should be addressed via a note to file and retraining e. A protocol deviation that should be documented f. A protocol deviation that should be reported to the IRB/IEC

Question 59

Which of the following documents has/have influenced the ethical principles within the current GCP guidelines? This question should have a single correct answer Question 41Answer a. The Nuremberg Code b. The Declaration of Helsinki c. The Paris Report d. A and B

Question 60

A planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants is called what? This question should have a single correct answer Question 42Select one: 1. An outcome measure 2. A primary objective 3. A hypothesis 4. None of the above

Question 61

Deviations from standard medical practice are considered research. Question 43Select one: True False

Question 62

A research hypothesis states what the researcher expects to find – it is the tentative answer to the research question that guides the entire study. Question 44Select one: True False

Question 63

The investigational new drug development process consists of which of the following? This question should have a single correct answer Question 45Answer a. Pre-clinical testing, 2 phases of clinical trials and regulatory submission, review and approval of the marketing application b. Pre-clinical testing, 3 phases of clinical trials and regulatory submission, review and approval of the marketing application c. Pre-clinical testing, 4 phases of clinical trials and regulatory submission, review and approval of the marketing application d. Pre-clinical testing, 5 phases of clinical trials and regulatory submission, review and approval of the marketing application

Question 64

The conduct of a sponsor's audit should be what? This question should have a single correct answer Question 46Answer a. Independent of, and separate from routine monitoring or quality control functions b. To evaluate trial conduct and compliance with the protocol, SOPs, GCPs and the applicable regulatory requirements c. Performed by individuals who are independent of the trial d. Done a minimum of every six months e. All of the above f. A, B and C only

Question 65

All of the following are key roles or entities involved in clinical trials EXCEPT which? This question should have a single correct answer Question 47Answer a. The Principal Investigator b. The Clinical Research Associate (CRA) c. The Sponsor d. The Contract Research Organization (CRO) e. The Institutional Review Board (IRB) or Independent Ethics Committee (IEC) f. The Patient Advocate g. The Clinical Research Coordinator (CRC) h. The Indpendent Data-Monitoring Committee (EDMC) or Data Safety Management Board (DSMB) i. Regulatory Authorities

Question 66

What is true of an impartial witness? This question should have a single correct answer Question 48Answer a. Should always be present during the informed consent process b. Is required during the informed consent process for all vulnerable subjects c. Should attend the informed consent process if the subject or their legally acceptable representative cannot read d. Should be independent of the trial e. All of the above f. C and D only

Question 67

All of the following are examples of documents and reports that are required in the context of clinical trial conduct EXCEPT which? This question should have a single correct answer Question 49Answer a. Monitoring visits reports b. Expedited safety reports c. Reports documenting communications between sponsors and sites (e.g., letters, written communications) d. Case Report Forms e. Patient status, recruitment and query reports f. Curriculum Vitae's for all site personnel g. Protocol deviation reports to IRBs/IECs