phases of an investigation quiz questions

1. A protocol is required to contain ________.

A description of the observations and measurements to fulfill the study's objectives

A description of the clinical procedures and laboratory procedures

A statement of the objectives and purpose

All of the above

21 CFR 312.23(6)(iii)

Explanation

21 CFR 312.23(6)(iii)

2. The purpose of an IRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and the welfare of human subjects.

True

False

The purpose of an Institutional Review Board (IRB) is to ensure that the rights and welfare of human subjects involved in research are protected. The IRB achieves this by conducting an advance review of research protocols and periodically reviewing ongoing research to ensure that appropriate steps are being taken to safeguard the participants. This includes assessing the informed consent process, evaluating the potential risks and benefits of the research, and ensuring that the research is conducted ethically and in compliance with applicable regulations and guidelines. Therefore, the statement that the purpose of an IRB is to assure the protection of human subjects' rights and welfare is true.

Explanation

The purpose of an Institutional Review Board (IRB) is to ensure that the rights and welfare of human subjects involved in research are protected. The IRB achieves this by conducting an advance review of research protocols and periodically reviewing ongoing research to ensure that appropriate steps are being taken to safeguard the participants. This includes assessing the informed consent process, evaluating the potential risks and benefits of the research, and ensuring that the research is conducted ethically and in compliance with applicable regulations and guidelines. Therefore, the statement that the purpose of an IRB is to assure the protection of human subjects' rights and welfare is true.

3. An IRB can do the following:

Disapprove research activities

Approve research activities

Require modifications to secure approval

All of the above

21 CFR 56.109(a)

Explanation

21 CFR 56.109(a)

4. The information that is given to a subject or the representative does not need to be in a language understandable to the subject or the representative.

True

False

21 CFR 50.20

Explanation

21 CFR 50.20

5. CFR stands for ______.

Code of Finance Regulations

Code of Federal Reserve

Code of Federal Regulations

Code of Free Regulations

21 CFR 50.1(b)

Explanation

21 CFR 50.1(b)

6. The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.

Research

Research subject's rights

Person/representative to contact in the event of a research-related emergency

All of the above

21 CFR 50.25(a)(7)

Explanation

21 CFR 50.25(a)(7)

7. The informed consent shall contain a description of ________.

Foreseeable risks or discomforts

Any benefits

Any alternative procedures

All of the above

21 CFR 50.25(a)(2-4)

Explanation

21 CFR 50.25(a)(2-4)

8. For a drug expected to be used in children, evaluation should be made in the appropriate age group.

True

False

E8 Section 3.1.4.3c

Explanation

E8 Section 3.1.4.3c

9. The safety and tolerability properties of a drug are commonly summarized across studies continuously during an investigational product's development, and in particular, for the submission of a marketing application.

True

False

E9 Section 6.2

Explanation

E9 Section 6.2

10. When there are sponsor representatives on the Independent Data Monitoring Committee, their role should be clearly defined in the committee's operating procedures.

True

False

E9 Section 4.6

Explanation

E9 Section 4.6

11. IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.

True

False

21 CFR 56.102 Definition - m

Explanation

21 CFR 56.102 Definition - m

12. An IRB can consist of all members in the same profession.

True

False

21 CFR 56.107(b)

Explanation

21 CFR 56.107(b)

13. In order for the IRB to approve research, the IRB shall determine that all of the following requirements have been met:

Risks to the subjects have been minimized

Risks to the subjects are reasonable in relation to the anticipated benefits

Selection of the subjects is equitable

All of the above

21 CFR 56.111(a)(1-3)

Explanation

21 CFR 56.111(a)(1-3)

14. When determining whether children are capable of providing assent, the IRB must take into account ______.

Maturity

Ages

Psychological state of the children involved

All of the above

21 CFR 50.55(b)

Explanation

21 CFR 50.55(b)

15. FDA stands for the ________.

Food and Device Administration

Freedom and Drug Association

Food and Drug Administration

Food and Drug Association

21 CFR 312.3(b)

Explanation

21 CFR 312.3(b)

16. An IEC ensured the protection of the ______ of human subjects in a clinical investigation.

Safety

Rights

Well-being

All of the above

21 CFR 312.3(b)

Explanation

21 CFR 312.3(b)

17. IRB stands for _______.

Institutional Research Board

Institutional Review Board

Institutional Research Branch

Institutional Research Board

21 CFR 50.3(i)

Explanation

21 CFR 50.3(i)

18. A statement that participation is voluntary is a ________.

Basic element

Additional element

Very good idea

Not required

21 CFR 50.25(a)(8)

Explanation

21 CFR 50.25(a)(8)

19. Any individual involuntarily confined or detained in a penal institution is known as prisoner.

True

False

45 CFR 46.303(c)

Explanation

45 CFR 46.303(c)

20. The term "parent" can refer to an adoptive parent.

True

False

45 CFR 46.402(d)

Explanation

45 CFR 46.402(d)

21. The primary endpoint should be the variable capable of providing the most clinically relevant and convincing evidence directly related to the primary objective of the trial.

True

False

E9 Section 2.2.2

Explanation

E9 Section 2.2.2

22. The use of a test article on a human subject in a life-threatening situation in which there is no standard acceptable treatment, and in which there is not sufficient tiem to obtain IRB approval is known as emergency use.

True

False

21 CFR 56.102 Definition - d

Explanation

21 CFR 56.102 Definition - d

23. Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.

True

False

21 CFR 58.33 (c)

Explanation

21 CFR 58.33 (c)

24. The quality assurance unit shall assure management that ____ are in conformance with the regulations.

Personnel

Equipment

Methods

All of the above

21 CFR 58.35 (a)

Explanation

21 CFR 58.35 (a)

25. When the IRB determines that assent is required, it also must determine whether and how assent must be documented.

True

False

21 CFR 50.55(g)

Explanation

21 CFR 50.55(g)

26. If the legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, does the subject need to be informed of the clinical investigation?

Yes

No

21 CFR 50.24(b)

Explanation

21 CFR 50.24(b)

27. Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.

True

False

45 CFR 46.203(b)

Explanation

45 CFR 46.203(b)

28. Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to formal completion of a trial is an interim analysis.

True

False

E9 Section 4.5

Explanation

E9 Section 4.5

29. The FDA requires specific elements to be included in an informed consent document.

True

False

The FDA, which stands for the Food and Drug Administration, mandates certain elements that must be present in an informed consent document. This means that it is indeed true that the FDA requires specific elements to be included in such a document.

Explanation

The FDA, which stands for the Food and Drug Administration, mandates certain elements that must be present in an informed consent document. This means that it is indeed true that the FDA requires specific elements to be included in such a document.

30. Clinical investigation involving greater than minimal risk but presenting the prospect of direct benefit may involve children as subjects only if the IRB finds and documents that ______.

The risk is justified by the anticipated benefit

Adequate provisions are made for soliciting the assent of the children and permission of their parents and guardians

All of the above

21 CFR 50.52(a-c)

Explanation

21 CFR 50.52(a-c)

31. Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.

True

False

45 CFR 46.206(b)

Explanation

45 CFR 46.206(b)

32. _______ means a child's affirmative agreement to participate in research.

Permission

Assent

Participation

None of the above

45 CFR 46.402(b)

Explanation

45 CFR 46.402(b)

33. Only the principal investigator is allowed to transcribe data from the document to the CRF.

True

False

The statement is false because it states that only the principal investigator is allowed to transcribe data from the document to the CRF. This is incorrect because there may be other authorized individuals, such as research assistants or data entry personnel, who are also allowed to transcribe data onto the CRF. The statement does not account for the possibility of multiple individuals being involved in the data transcription process.

Explanation

The statement is false because it states that only the principal investigator is allowed to transcribe data from the document to the CRF. This is incorrect because there may be other authorized individuals, such as research assistants or data entry personnel, who are also allowed to transcribe data onto the CRF. The statement does not account for the possibility of multiple individuals being involved in the data transcription process.

34. The contents of a protocol should generally contain:

Trial objectives and purpose

Assessment of efficacy

Data handling and record keeping

All of the above

The contents of a protocol should generally contain trial objectives and purpose, assessment of efficacy, and data handling and record keeping. Including all of these components in a protocol ensures that the objectives and purpose of the trial are clearly defined, the efficacy of the intervention is properly assessed, and the data collected during the trial is handled and recorded appropriately. This comprehensive approach helps to ensure the accuracy and reliability of the trial results.

Explanation

The contents of a protocol should generally contain trial objectives and purpose, assessment of efficacy, and data handling and record keeping. Including all of these components in a protocol ensures that the objectives and purpose of the trial are clearly defined, the efficacy of the intervention is properly assessed, and the data collected during the trial is handled and recorded appropriately. This comprehensive approach helps to ensure the accuracy and reliability of the trial results.

35. Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.

Drug for human use

Medical device for human use

Biological product for human use

All of the above

21 CFR 56.102 Definition - l

Explanation

21 CFR 56.102 Definition - l

36. Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.

Current summary of training

Current summary of experience

A job description

All of the above

21 CFR 58.29 (b)

Explanation

21 CFR 58.29 (b)

37. Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.

True

False

21 CFR 50.56(a)

Explanation

21 CFR 50.56(a)

38. Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.

True

False

21 CFR 312.3(b)

Explanation

21 CFR 312.3(b)

39. DOD stands for _______.

Division of Defense

Department of Direction

Department of Defense

None of the above

21 CFR 50.23(d)(1)

Explanation

21 CFR 50.23(d)(1)

40. Clinical investigation means any experiment that involves a test article and no human subjects.

True

False

21 CFR 50.3(c)

Explanation

21 CFR 50.3(c)

41. Parent means a child's biological parent, but it does not refer to an adoptive parent.

True

False

21 CFR 50.3(p)

Explanation

21 CFR 50.3(p)

42. No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.

Geographical location

The time when the clinical trial was conducted

The medical practices of investigators and clinics

All of the above

E9 Section 2.2.1

Explanation

E9 Section 2.2.1

43. What date should an investigator write when he failed to sign the consent form on the date of the consent?

Date of consent

The day after the date of consent

Date of the investigator's signature

When an investigator fails to sign the consent form on the date of the consent, he should write the date of his signature when he eventually signs the form. This is because the date on the consent form should accurately reflect when the investigator actually signed it, rather than the original date of the consent.

Explanation

When an investigator fails to sign the consent form on the date of the consent, he should write the date of his signature when he eventually signs the form. This is because the date on the consent form should accurately reflect when the investigator actually signed it, rather than the original date of the consent.

44. IND means ______.

Investigation new drug application

Investigational new drug application

Investigator new drug application

Investigational new device application

21 CFR 312.3(b)

Explanation

21 CFR 312.3(b)

45. The obtaining of informed consent shall be deemed feasible unless, before use of test article, both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing that _______.

The human subject is confronted by a life-threatening situation

Time is not sufficient to obtain consent from the subject's legal representative

All of the above

21 CFR 50.23(a)(1-3)

Explanation

21 CFR 50.23(a)(1-3)

46. The ______ means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in research.

Witness

Physician

Legally authorized representative

All of the above

21 CFR 50.3(I)

Explanation

21 CFR 50.3(I)

47. _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.

Parents

Guardians

Children

Wards

45 CFR 46.402(a)

Explanation

45 CFR 46.402(a)

48. An overall summary and synthesis of the evidence on safety and efficacy from all the reported clinical trials is not required for a marketing application.

True

False

E9 Section 7.2

Explanation

E9 Section 7.2

49. For an IRB, there must be at least one member ________.

Whose primary concerns are in the scientific area

Whose primary concerns are in the non-scientific area

Who is not affiliated with the institution

All of the above

21 CFR 56.107(c)(d)

Explanation

21 CFR 56.107(c)(d)

50. ______ are not considered to be a vulnerable population.

Children

Prisoners

Pregnant women

Adults

21 CFR 56.111(3)

Explanation

21 CFR 56.111(3)

51. The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.

True

False

21 CFR 58.35 (7)

Explanation

21 CFR 58.35 (7)

52. _______ means a child who is placed in the legal custody of the state or other agency, institution, or entity, consistent with federal, state, or local law.

Orphan

Foster child

Ward

Guardian

21 CFR 50.3(q)

Explanation

21 CFR 50.3(q)

53. No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.

The purpose of the activity is to meet the health needs of the fetus

The risk to the fetus will be minimal

A and b

None of the above

45 CFR 46.208(a)

Explanation

45 CFR 46.208(a)

54. When a rating scale is used as a primary variable, it is important to address the following factors:

Sensitivity for discriminating different medical conditions

Content validity

Inter- and intra-rater reliability

All of the above

E9 Section 2.2.2

Explanation

E9 Section 2.2.2

55. In combination with blinding, ________ helps to avoid possible bias in the selection and allocation of subjects arising from the predictability of treatment assignments.

Stratification

Randomization

Unblinding

All of the above

E9 Section 2.3.2

Explanation

E9 Section 2.3.2

56. ______ means that the probability of and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Maximum risk

Minimal risk

Risk

All of the above

21 CFR 56.102 Definition - i

Explanation

21 CFR 56.102 Definition - i

57. ________ means an individual who actually conducts a clinical investigation.

Clinical Research Organization

Food and Drug Administration

Sponsor

Investigator

21 CFR 312.3(b)

Explanation

21 CFR 312.3(b)

58. An IND may be submitted for one or more phases of an investigation.

True

False

21 CFR 312.21

Explanation

21 CFR 312.21

59. The FDA shall provide a written determination ______ after FDA received the IND or earlier.

15 days

30 days

2 months

1 year

21 CFR 312.20(c)

Explanation

21 CFR 312.20(c)

60. ______ studies usually include from several hundred to several thousand subjects.

Phase 1

Phase 2

Phase 3

All of the above

21 CFR 312.21(c)

Explanation

21 CFR 312.21(c)

61. Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.

Parent(s)

Guardian

Grandparent(s)

Parent(s) or guardian

21 CFR 50.3(r)

Explanation

21 CFR 50.3(r)

62. A pregnant woman may be involved as a subject in an activity covered in Subpart B if the risk to the fetus is minimal.

True

False

45 CFR 46.207(a)

Explanation

45 CFR 46.207(a)

63. Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.

True

False

45 CFR 46.210

Explanation

45 CFR 46.210

64. Depending on the drug and endpoint studied, pharmacodynamic studies and studies relating to drug blood levels to response (PK/PD) may be conducted in _________.

Patients with a target disease

Unhealthy volunteer subjects

Healthy volunteer subjects

A and c

E8 Section 3.1.3.1c

Explanation

E8 Section 3.1.3.1c

65. In reporting adverse events for a trial , you will need to report ________ adverse events.

Treatment-related

Possible

Nontreatment-related

All

E9 Section 6.3

Explanation

E9 Section 6.3

66. An IRB shall conduct continuing review of research covered at intervals appropriate to the degree of risk, but not _______ a year.

Less than twice

Less than once

Less than three

More than two years

21 CFR 56.109(f)

Explanation

21 CFR 56.109(f)

67. A/An ______ must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the clinical investigation.

Advocate

Parent

Witness

None of the above

21 CFR 50.56(b)(3)

Explanation

21 CFR 50.56(b)(3)

68. The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?

True

False

E8 Section 1.c

Explanation

E8 Section 1.c

69. ________ are the two most important design techniques for avoiding bias in a clinical trial.

Randomization and stratification

Randomization and unblinding

Randomization and endpoints

Randomization and blinding

E9 Section 2.3

Explanation

E9 Section 2.3

70. Investigational new drug means a _______ that is used in a clinical investigation.

New biological drug

New drug

All of the above

None of the above

21 CFR 312.3(b)

Explanation

21 CFR 312.3(b)

71. The father's informed consent need not be secured for the following:

The pregnancy resulted from rape

Father is not reasonably available

Father's identity or whereabouts is reasonably ascertained

A and b

45 CFR 46.207(b)

Explanation

45 CFR 46.207(b)

72. The probability and magnitude of physical or psychological harm that is normally encountered in daily lives of healthy persons is known as _______.

Minimal risk

Risk

High risk

All of the above

45 CFR 46.303(d)

Explanation

45 CFR 46.303(d)

73. An individual may not serve as an advocate for more than one child.

True

False

45 CFR 46.409(b)

Explanation

45 CFR 46.409(b)

74. Phase 2 is usually considered to start with the initiation of studies in which the secondary objective is to explore the therapeutic efficacy in animals

True

False

E8 Section 3.1.3.2

Explanation

E8 Section 3.1.3.2

75. What FDA document must all investigators sign prior to participating in a drug clinical trial?

1571

483

1572

All investigators must sign FDA Form 1572 prior to participating in a drug clinical trial. This form is known as the Statement of Investigator and is required by the FDA to ensure that investigators understand their responsibilities and comply with regulations during the trial. By signing this document, investigators acknowledge their commitment to follow the protocol, protect the rights and welfare of participants, and accurately report data to the FDA.

Explanation

All investigators must sign FDA Form 1572 prior to participating in a drug clinical trial. This form is known as the Statement of Investigator and is required by the FDA to ensure that investigators understand their responsibilities and comply with regulations during the trial. By signing this document, investigators acknowledge their commitment to follow the protocol, protect the rights and welfare of participants, and accurately report data to the FDA.

76. Each IRB shall have at least _______ members, with varying background to promote complte and adequate review of the research activities at their institution.

3

4

5

10

21 CFR 56.107(a)

Explanation

21 CFR 56.107(a)

77. For a double blind study, ________ are unaware of the treatment assignments.

Participant

Sponsor staff and participant

Investigator

Investigator, sponsor staff, and participant

E8 Section 3.2.2.5b

Explanation

E8 Section 3.2.2.5b

78. The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.

Stage of development

Stage of disease

Indication to be studied

A and c

E8 Section 3.2.2.1

Explanation

E8 Section 3.2.2.1

79. Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.

Conscious

Unconscious

Conscious and unconscious

None of the above

E9 Section 2.3.1

Explanation

E9 Section 2.3.1

80. According to FDA guidelines, the financial disclosure form should be completed by all study personnel that have a significant role in the study.

True

False

According to FDA guidelines, all study personnel who play a significant role in the study are required to complete the financial disclosure form. This form ensures transparency and helps identify any potential conflicts of interest that could influence the study's outcome. By requiring all relevant personnel to disclose their financial interests, the FDA aims to maintain the integrity and credibility of the study results. Therefore, the statement is true.

Explanation

According to FDA guidelines, all study personnel who play a significant role in the study are required to complete the financial disclosure form. This form ensures transparency and helps identify any potential conflicts of interest that could influence the study's outcome. By requiring all relevant personnel to disclose their financial interests, the FDA aims to maintain the integrity and credibility of the study results. Therefore, the statement is true.

81. The pre-analysis review blinded to study treatment should ______.

Check possible transformations and define outliers

Reconsider the use of parametric or nonparametric methods

Cover decisions concerning the inclusions of subjects

A and b

E9 Section 7.1

Explanation

E9 Section 7.1

82. A waiver request is required to contain at least _______.

Other information justifying a waiver

A description of alternative submission or course of action

An explanation of why the sponsor's compliance with the requirement is unnecessary or cannot be achieved

All of the above

21 CFR 312.10(a)

Explanation

21 CFR 312.10(a)

83. In general, protocols for ______ studies may be less detailed and more flexible.

Phase 1

Phase 2

Phase 3

All of the above

21 CFR 312.23(6)

Explanation

21 CFR 312.23(6)

84. Sponsor means a person who does not initiate a clinical investigation.

True

False

21 CFR 50.3(e)

Explanation

21 CFR 50.3(e)

85. Protocols involving an exception to the informed consent requirement under Section 50.24 must be performed under a separate investigational new drug application or investigational device exemption that clearly identifies such protocols as protocols that may include subjects who are unable to consent.

True

False

21 CFR 50.24(d)

Explanation

21 CFR 50.24(d)

86. The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:

Pregnant women

Human in vitro fertilization

The fetus

All of the above

45 CFR 46.201

Explanation

45 CFR 46.201

87. For a Phase 2 study, which of the following statements is not correct:

They include several hundred to several thousand subjects.

They are well controlled.

They are closely monitored.

They usually involve no more than several hundred subjects

21 CFR 312.21(c)

Explanation

21 CFR 312.21(c)

88. If an IRB uses an expedited review procedure, the other IRB members do not have to be informed of the research proposals which have been approved by expedited review.

True

False

21 CFR 56.110(c)

Explanation

21 CFR 56.110(c)

89. If the research presents no more than minimal risk or harm and involves no procedure for which written consent is normally required outside the research content, the IRB may waive the requirement for a signed written consent form.

True

False

21 CFR 56.109(c)(1)

Explanation

21 CFR 56.109(c)(1)

90. A ______ fetus means a fetus ex utero which, although living, is not viable.

Viable

Nonviable

Premature

None of the above

45 CFR 46.203(e)

Explanation

45 CFR 46.203(e)

91. The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.

Interim analysis

Meta-analysis

Blind review

Analysis plan

E9 Annex 1 Glossary

Explanation

E9 Annex 1 Glossary

92. A representative of the _____ shall have access to the written procedures established for the inspection.

OHRP

Study director

FDA

None of the above

21 CFR 58.35 (d)

Explanation

21 CFR 58.35 (d)

93. Phase 1 studies may be conducted in ______.

Patients

Animals

Normal volunteer subjects

A and c

21 CFR 312.21(a)

Explanation

21 CFR 312.21(a)

94. The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.

Protocol

Amendment

IND

Waiver

21 CFR 312.20(a)

Explanation

21 CFR 312.20(a)

95. The sponsor shall submit a/an _____ of all submissions to the IND file, including the original submission and all of the amendments and reports.

Two copies

Three copies

Original and two copies

One copy

21 CFR 312.23

Explanation

21 CFR 312.23

96. The product of conception from the implantation time, until a determination is made, following expulsion or extraction, that it is viable is known as a ________.

Dead fetus

Fetus

Nonviable fetus

None of the above

45 CFR 46.203(c)

Explanation

45 CFR 46.203(c)

97. After the sponsor has found that the results of an investigation appear to establish sufficient data to support a marketing application, it is acceptable for the sponsor to prolong the investigation.

True

False

21 CFR 312.7(c)

Explanation

21 CFR 312.7(c)

98. If the short form method is utilized, the witness shall sign _______.

Copy of the summary

Short form

Short form and copy of the summary

Consent form

21 CFR 50.27(b)(2)

Explanation

21 CFR 50.27(b)(2)

99. If 500 subjects were enrolled on a clinical trial and 10 subjects were excluded from the analysis, the report will only reflect the 490 subjects.

True

False

E9 Section 7.1

Explanation

E9 Section 7.1

100. Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.

Investigator

Sponsor

Investigator and sponsor

Research coordinator/research nurse

E8 Section 2.1

Explanation

E8 Section 2.1

101. Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.

True

False

21 CFR 58.29 (e)

Explanation

21 CFR 58.29 (e)

102. The ________ may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member's participation in a particular military operation.

Secretary of Defense

Vice President

President

All of the above

21 CFR 50.23(d)(1)

Explanation

21 CFR 50.23(d)(1)

103. For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.

True

False

In an industry sponsored trial, it is not appropriate for a site to allow only the sponsor's monitor access to the regulatory files. Regulatory files should be accessible to all relevant parties, including regulatory authorities, ethics committees, and other monitors or auditors. This ensures transparency and accountability in the trial process.

Explanation

In an industry sponsored trial, it is not appropriate for a site to allow only the sponsor's monitor access to the regulatory files. Regulatory files should be accessible to all relevant parties, including regulatory authorities, ethics committees, and other monitors or auditors. This ensures transparency and accountability in the trial process.

104. A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.

True

False

21 CFR 58.35 (11)

Explanation

21 CFR 58.35 (11)

105. If a clinical investigation is approved, the IRB must require appointment of a/an ______ for each child who is a ward.

Parent

Advocate

Guardian

All of the above

21 CFR 50.56(b)

Explanation

21 CFR 50.56(b)

106. A _______ trial has the primary objective of showing that the reponse to the investigational product is superior to a comparative agent.

Noninferiority

Multicenter

Superiority

Equivalence

E9 Annex 1 Glossary

Explanation

E9 Annex 1 Glossary

107. The only way an IRB member may participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest is to provide information to the IRB.

True

False

21 CFR 56.107(e)

Explanation

21 CFR 56.107(e)

108. Subpart D deals with clinical investigations for _________ .

Adults

Children

Vulnerable persons

All of the above

21 CFR 50.50

Explanation

21 CFR 50.50

109. The documentation required after using a test article shall be submitted to the IRB within _____ working days.

Five

Three

Ten

Seven

21 CFR 50.23(c)

Explanation

21 CFR 50.23(c)

110. When a short form written consent document is used, there shall be a ________ to the oral presentation.

Witness

Witness and subject

Legal authorized representative

None of the above

21 CFR 50.27(b)(2)

Explanation

21 CFR 50.27(b)(2)

111. The ______ has overall responsibility for the technical conduct of the study.

Study coordinator

Research nurse

Study director

All of the above

21 CFR 58.33

Explanation

21 CFR 58.33

112. A test article includes all of the following except for _______.

Medical device for animal use

Color additive

Human food additives

Electronic product

21 CFR 50.3(j)

Explanation

21 CFR 50.3(j)

113. The composition of the board where prisoners are involved shall meet the following requirements:

At least one board member must be a prisoner

A majority of the board shall have no association with the prison involved

A and b

None of the above

45 CFR 46.304(a,b)

Explanation

45 CFR 46.304(a,b)

114. Testing facility management may replace the study director during the conduct of the study.

True

False

21 CFR 58.31 (b)

Explanation

21 CFR 58.31 (b)

115. Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.

Protocol

Consent form

Written information sheet

None of the above

21 CFR 50.23(d)(1)(viii)

Explanation

21 CFR 50.23(d)(1)(viii)

116. A statement that significant new findings developed during the course of the research which may relate tot he subject's willingness to continue participation will be provided to the subject is a/an _______.

Basic element

Good idea

Additional element

None of the above

21 CFR 50.25(b)(5)

Explanation

21 CFR 50.25(b)(5)

117. The regulations in Subpart C are applicable to the biomedical and behavioral research conducted by the Department of Health and Human Services involving _______ as subjects.

Fetuses

Pregnant women

Prisoners

All of the above

45 CFR 46.301(a)

Explanation

45 CFR 46.301(a)

118. Where parental permission is to be obtained, the IRB may find that the permission of ________ is sufficient, if consistent with state law, for clinical investigations to be conducted under 50.51 and 50.52.

Both parents

One parent

A legally authorized representative

All of the above

21 CFR 50.55(e)(1)

Explanation

21 CFR 50.55(e)(1)

119. Even when the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement if ________.

The clinical investigation involves no more than minimal risk

The waiver will adversely affect the rights and welfare of the subjects

The clinical investigation could not practically be carried out without the waiver

All of the above

A and c

21 CFR 50.55(d)(1 and 3)

Explanation

21 CFR 50.55(d)(1 and 3)

120. The contract research organization assumes all of the following for a sponsor except for ______.

Evaluation of reports

Accrual of subjects

Design of the protocol

Preparation of materials to be submitted to the FDA

21 CFR 312.3(b)

Explanation

21 CFR 312.3(b)

121. _______ are expanded controlled and uncontrolled trials.

Phase 1

Phase 2

Phase 3

All of the above

21 CFR 312.21(c)

Explanation

21 CFR 312.21(c)

122. ________ is a technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be identical.

Blinding

Stratification

Double dummy

Randomization

E9 Annex 1 Glossary

Explanation

E9 Annex 1 Glossary

123. _______ means any experiment that involves a test article and one or more human subjects.

Clinical investigation

Clinical research

Research

All of the above

21 CFR 56.102 Definition - c

Explanation

21 CFR 56.102 Definition - c

124. The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.

Office for Human Research Protection

National Cancer Institute

A and b

Department of Health and Human Services

45 CFR 46.204(a)

Explanation

45 CFR 46.204(a)

125. If the clinical investigation involves more than minimal risk and no prospect of direct benefit, children may only be involved if the ______ provides approval.

IRB

Parent

Child

All of the above

21 CFR 50.53

Explanation

21 CFR 50.53

126. The term _______ as used in section 520(g) of the act is deemed to be synonymous with the term institution for purposes of this part.

Site

Facility

Research organization

Membership

21 CFR 56.102 Definition - f

Explanation

21 CFR 56.102 Definition - f

127. The ______ provide adequate follow-up to assess whether there are beneficial or adverse health consequences that result from the use of the investigational product.

President

Secretary of Defense

Department of Defense

None of the above

21 CFR 50.23(d)(1)(xi)

Explanation

21 CFR 50.23(d)(1)(xi)

128. The _______ is responsible for ensuring the adequacy of the information required in Section 50.25 (except for the information described in 50.25(a)(8).

IRB

Sponsor

Investigator

Department of Defense

21 CFR 50.23(e)(5)

Explanation

21 CFR 50.23(e)(5)

129. Any investigation commenced before July 27, 1981, and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date still requires IRB review.

True

False

21 CFR 56.103 b

Explanation

21 CFR 56.103 b

130. A clinical investigation involving the use of a placebo is exempt from the requirements of this part if the investigation does not otherwise submission of an IND.

True

False

21 CFR 312.2(5)

Explanation

21 CFR 312.2(5)

131. The sponsor will provide training to the appropriate medical personnel and potential recipients on the specific investigation new drug to be administered prior to its use.

True

False

21 CFR 50.23(d)(1)(xiv)

Explanation

21 CFR 50.23(d)(1)(xiv)

132. The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.

Study director

Study coordinator

Quality assurance unit

All of the above

21 CFR 58.35 (21)

Explanation

21 CFR 58.35 (21)

133. The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.

True

False

21 CFR 56.102 Definition - c

Explanation

21 CFR 56.102 Definition - c

134. ______ means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.

Patient

Subject

Human subject

All of the above

21 CFR 56.102 Definition - e

Explanation

21 CFR 56.102 Definition - e

135. Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.

Human pharmacology

Therapeutic confirmatory

Therapeutic exploratory

Therapeutic use

E8 Table 1

Explanation

E8 Table 1

136. The duly constituted IRB, must include at least ______ non-affiliated members who shall not be employees or officers of the Federal Government and shall be required to obtain any necessary security clearances.

Five

Three

Two

One

21 CFR 50.23(d)(2)

Explanation

21 CFR 50.23(d)(2)

137. Which of the following is not an additional duty of the IRB where prisoners are involved:

The risks are not commensurate to those of non-prisoner volunteers

Selection procedures are fair to all prisoners

Decisions regarding parole are not based on study participation

The information is presented in a language which is understandable to the subject population

45 CFR 46.305(3)

Explanation

45 CFR 46.305(3)

138. The IRB responsible for the review, approval, and continuing review of the clinical investigation described in Section 50.24 may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is not a member of or consultant to the IRB and who is participating in the clinical investigation).

True

False

21 CFR 50.24(a)

Explanation

21 CFR 50.24(a)

139. ________ is not an objective of a human pharmacology study.

Refine dosing recommendations

Assess tolerance

Estimate activity

Explore drug metabolism

E8 Table 1

Explanation

E8 Table 1

140. Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.

Phase 1

Phase 2

Phase 3

Phase 4

E8 Section 3.1.3.4

Explanation

E8 Section 3.1.3.4

141. An individual who is authorized under state or local law to consent on behalf of a child for general medical care is know as a ________.

Guardian

Parent

A and b

All of the above

45 CFR 46.402(e)

Explanation

45 CFR 46.402(e)

Phases Of An Investigation Quiz Questions

1. A protocol is required to contain ________.

2.

What first name or nickname would you like us to use?

2. The purpose of an IRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and the welfare of human subjects.

3. An IRB can do the following:

4. The information that is given to a subject or the representative does not need to be in a language understandable to the subject or the representative.

5. CFR stands for ______.

6. The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.

7. The informed consent shall contain a description of ________.

8. For a drug expected to be used in children, evaluation should be made in the appropriate age group.

9. The safety and tolerability properties of a drug are commonly summarized across studies continuously during an investigational product's development, and in particular, for the submission of a marketing application.

10. When there are sponsor representatives on the Independent Data Monitoring Committee, their role should be clearly defined in the committee's operating procedures.

11. IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.

12. An IRB can consist of all members in the same profession.

13. In order for the IRB to approve research, the IRB shall determine that all of the following requirements have been met:

14. When determining whether children are capable of providing assent, the IRB must take into account ______.

15. FDA stands for the ________.

16. An IEC ensured the protection of the ______ of human subjects in a clinical investigation.

17. IRB stands for _______.

18. A statement that participation is voluntary is a ________.

19. Any individual involuntarily confined or detained in a penal institution is known as prisoner.

20. The term "parent" can refer to an adoptive parent.

21. The primary endpoint should be the variable capable of providing the most clinically relevant and convincing evidence directly related to the primary objective of the trial.

22. The use of a test article on a human subject in a life-threatening situation in which there is no standard acceptable treatment, and in which there is not sufficient tiem to obtain IRB approval is known as emergency use.

23. Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.

24. The quality assurance unit shall assure management that ____ are in conformance with the regulations.

25. When the IRB determines that assent is required, it also must determine whether and how assent must be documented.

26. If the legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, does the subject need to be informed of the clinical investigation?

27. Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.

28. Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to formal completion of a trial is an interim analysis.

29. The FDA requires specific elements to be included in an informed consent document.

30. Clinical investigation involving greater than minimal risk but presenting the prospect of direct benefit may involve children as subjects only if the IRB finds and documents that ______.

31. Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.

32. _______ means a child's affirmative agreement to participate in research.

33. Only the principal investigator is allowed to transcribe data from the document to the CRF.

34. The contents of a protocol should generally contain:

35. Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.

36. Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.

37. Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.

38. Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.

39. DOD stands for _______.

40. Clinical investigation means any experiment that involves a test article and no human subjects.

41. Parent means a child's biological parent, but it does not refer to an adoptive parent.

42. No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.

43. What date should an investigator write when he failed to sign the consent form on the date of the consent?

44. IND means ______.

45. The obtaining of informed consent shall be deemed feasible unless, before use of test article, both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing that _______.

46. The ______ means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in research.

47. _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.

48. An overall summary and synthesis of the evidence on safety and efficacy from all the reported clinical trials is not required for a marketing application.

49. For an IRB, there must be at least one member ________.

50. ______ are not considered to be a vulnerable population.

51. The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.

52. _______ means a child who is placed in the legal custody of the state or other agency, institution, or entity, consistent with federal, state, or local law.

53. No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.

54. When a rating scale is used as a primary variable, it is important to address the following factors:

55. In combination with blinding, ________ helps to avoid possible bias in the selection and allocation of subjects arising from the predictability of treatment assignments.

56. ______ means that the probability of and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

57. ________ means an individual who actually conducts a clinical investigation.

58. An IND may be submitted for one or more phases of an investigation.

59. The FDA shall provide a written determination ______ after FDA received the IND or earlier.

60. ______ studies usually include from several hundred to several thousand subjects.

61. Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.

62. A pregnant woman may be involved as a subject in an activity covered in Subpart B if the risk to the fetus is minimal.

63. Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.

64. Depending on the drug and endpoint studied, pharmacodynamic studies and studies relating to drug blood levels to response (PK/PD) may be conducted in _________.

65. In reporting adverse events for a trial , you will need to report ________ adverse events.

66. An IRB shall conduct continuing review of research covered at intervals appropriate to the degree of risk, but not _______ a year.

67. A/An ______ must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the clinical investigation.

68. The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?

69. ________ are the two most important design techniques for avoiding bias in a clinical trial.

70. Investigational new drug means a _______ that is used in a clinical investigation.

71. The father's informed consent need not be secured for the following:

72. The probability and magnitude of physical or psychological harm that is normally encountered in daily lives of healthy persons is known as _______.

73. An individual may not serve as an advocate for more than one child.

74. Phase 2 is usually considered to start with the initiation of studies in which the secondary objective is to explore the therapeutic efficacy in animals

75. What FDA document must all investigators sign prior to participating in a drug clinical trial?

76. Each IRB shall have at least _______ members, with varying background to promote complte and adequate review of the research activities at their institution.

77. For a double blind study, ________ are unaware of the treatment assignments.