SoCRA Exam Prep Questions
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- 1.Which of the following is IRB Functions and Regulations?
- A.
21CFR56.108 Subpart D
- B.
21CFR56.108 Subpart C
- C.
21CFR56.106 Subpart B
- D.
I seriously can't believe this is a question
- 2.
- 3.The FDA form 483 is used for _______
- 4.The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as
- A.
The ICH
- B.
Good Clinical Practice (GCP)
- C.
The Declaration of Helsinki
- D.
Fundamental Ethical Principles (FEP)
- 5.
- A.
True
- B.
False
- 6.A(n) _________ is an investigational or marketed product, or placebo, used as a reference in a clinical trial.
- 7.21CFR56.107 Subpart B is IRB Membership
- A.
True
- B.
False
- 8.What is 21CFR50.23 Subpart B?
- A.
Documentation of Informed Consent
- B.
Exception from Informed Consent Requirements for Emergency Research
- C.
Exception from General Requirements
- D.
General Requirements for Informed Consent
- 9.This form is used for the voluntary reporting of adverse events and product problems
- 10.
- A.
IRB Documentation
- B.
IRB Exemptions
- C.
IRB Duties
- D.
IRB Membership Guidelines
- 11.
- A.
Mission statement of the ICH
- B.
Mission statement of the GCP Guidelines
- C.
Mission statement of the Declaration of Helsinki
- D.
Mission statement of Canada Health
- 12.The object of GCP is part of the ICH mission statement.
- A.
True
- B.
False
- 13.What is the FDA form 3455?
- A.
Certification - Disclosure of Conflict of Interest
- B.
Declaration of Conflict of Interest
- C.
Certification - Financial Interests and Arrangements of Clinical Investigators
- D.
Disclosure - Financial Interests and Agreements of Clinical Investigators
- 14.
- A.
Clinical Investigations not involving greater than minimal risk - children
- B.
Clinical Investigations involving greater than minimal risk - children
- C.
Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition - children
- D.
Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects – children
- 15.What is a person or an organization (commercial, academic, or other) contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function?
- A.
CRO - Clinical Research Organization
- B.
CRO - Contracted Research Organization
- C.
CRO - Center for Research Operations
- D.
CRO - Contracted Research Operations
- 16.
- A.
Registration
- B.
IRB Membership
- C.
IRB Functions and Operations
- D.
Option4
- 17.
- A.
IRB documentation
- B.
IRB membership
- C.
IRB functions and operations
- D.
IRB review of research
- 18.
- A.
21CFR11
- B.
45CFR46
- C.
21CFR812
- D.
21CFR312
- 19.When a short form is used for Informed Consent, the witness must sign either the short form or the summary.
- A.
True
- B.
False
- 20.21CFR56 is IRB Functions and Operations
- A.
True
- B.
False
- 21.What is the FDA form 3454?
- A.
Certification - Disclosure of Conflict of Interest
- B.
Declaration of Conflict of Interest
- C.
Certification - Financial Interests and Arrangements of Clinical Investigators
- D.
Declaration - Financial Interests and Arrangements of Clinical Investigators
- 22.What is the federal department responsible for helping people of Canada maintain and improve their health?
- A.
Federal Department of Food and Drug Administration
- B.
Health Canada
- C.
Canada Health
- D.
Federal Department of Canadian Health and Safety
- 23.What is 45CFR46?
- A.
HHS - Protection of Human Subjects
- B.
DDS - Protection of Human Subjects
- C.
FDA - Protection of Research Participants
- D.
HHS - Protection of Research Participants
- 24.What is the minimum number of IRB members?
- A.
2
- B.
10
- C.
15
- D.
5
- 25.__________is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.
- 26.What is 21CFR50 Subpart B?
- A.
Informed consent of Human Subjects
- B.
Additional Safeguards for Children in Clinical Investigations
- C.
IRB Functions and Operations
- D.
Records and Reports
- 27.What is 45CFR46 Subpart C?
- A.
Additional Protection for Children and Unborn Fetuses
- B.
Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
- C.
Additional Protection for Prisoners and Vulnerable Subjects
- D.
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
- 28.What is 21CFR50.25 Subpart B?
- A.
Elements of Informed Consent
- B.
Documentation of Informed Consent
- C.
Exemptions of Informed Consent
- D.
Documentation of Emergency Use of Experimental Treatments
- 29.Under 21CFR312, form___________ is the statement of the investigator of a clinical trial
- 30.What does 21CFR54 deal with?
- A.
IRB regulations
- B.
Exemptions of Informed Consent for emergency use
- C.
Financial disclosure of clinical investigators
- D.
Protection of human subjects: prisoners
- 31.
- A.
Requirements for permission by parents or guardians and for assent by children.
- B.
Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
- C.
Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
- D.
Wards
- 32.Who monitors the progress of all clinical trial investigations being conducted under its IND?
- A.
The Principle Investigator
- B.
The Institutional Review Board
- C.
The Sponsor
- D.
The CRO
- 33.What is 21CFR50 Subpart D?
- A.
Records and Reports
- B.
Protection of Human Subjects
- C.
IRB Functions and Operations
- D.
Additional Safeguards for Children in Clinical Investigations
- 34.The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
- A.
True
- B.
False
- 35.What is 21CFR50.20 Subpart B?
- A.
Exception from General Requirements
- B.
General Requirements for Informed Consent
- C.
Exception from Informed Consent Requirements for Emergency Research
- D.
Documentation of Informed Consent
- 36.The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR_____
- 37.HHS stands for________
- 38.What is 21CFR50.55 Subpart D?
- A.
Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
- B.
Requirements for permission by parents or guardians and for assent by children.
- C.
Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
- D.
Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
- 39.The "Doctor's Trial" prompted the Belmont Report.
- A.
True
- B.
False
- 40.
- A.
Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to health, safety, or the well-fare of the subject.
- B.
Is intended as an implant and presents a potential for serious risk to health, safety, or the well-fare of the subject.
- C.
For use of the substantial importance of diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents potential risk to health, safety, or well-fare of the subject.
- D.
Option4
- 41.
- 42.What is 21CFR50.27 Subpart B?
- A.
Documentation of informed consent
- B.
Exemptions of Informed Consent
- C.
Exception from Informed Consent Requirements for Emergency Research
- D.
General Requirements for Informed Consent
- 43.What is 21CFR56.110 Subpart C?
- A.
IRB review of research
- B.
IRB functions and operations
- C.
Expedited review procedures for certain kinds of research involving no more than minimal risk for minor changes in approved research
- D.
IRB registration
- 44.What is 21CFR50.52 Subpart D?
- A.
Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children
- B.
Clinical Investigations not involving greater than minimal risk - children
- C.
Clinical Investigations involving greater than minimal risk - children
- D.
Option4
- 45.A ________is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
- 46.The IRB may, for some or all subjects, waive the requirement that the subject, or the subject's legally authorized representative, sign a written consent form if it finds that the research presents more than minimal risk of harm to subjects and involves no procedures for which written consent is normal required outside the research context.
- A.
True
- B.
False
- 47.21CFR56 Subpart B is IRB Documentation.
- A.
True
- B.
False
- 48.The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is..
- A.
21CFR56
- B.
21CFR812
- C.
21CFR11
- D.
21CFR312
- 49.The Code of Federal Regulations that applies to Institutional Review Boards is..
- A.
45CFR46
- B.
21CFR312
- C.
21CFR56
- D.
21CFR50
- 50.What is 21CFR50.51 Subpart D?
- A.
Clinical Investigations involving minimal risk - prisoners
- B.
Clinical Investigations not involving greater than minimal risk - children
- C.
Clinical Investigations involving greater than minimal risk - children
- D.
Additional Safeguards for Children in Clinical Investigations
- 51.What is 45CFR46 Subpart B?
- A.
Additional Safeguards and Protection
- B.
Additional Protection for Prisoners and Vulnerable Subjects
- C.
Additional Protection for Children and Unborn Fetuses
- D.
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
- 52.The World Medical Association (WMA) ethical principles for medical research involving human subjects is called..
- A.
The Belmont Report
- B.
The National Research Act
- C.
The International Research Act
- D.
The Declaration of Helsinki
- 53.
- A.
Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
- B.
Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
- C.
Requirements for permission by parents or guardians and for assent by children.
- D.
Option4
- 54.What is 21CFR50.24 subpart B?
- A.
Documentation of Informed Consent
- B.
Exception from General Requirements
- C.
General Requirements for Informed Consent
- D.
Exception from Informed Consent Requirements for Emergency Research
- 55.What is 45CFR46 Subpart A?
- A.
Basic HHS policy for Protection of Human Research Subjects
- B.
HHS Policy for Human Subjects Protection
- C.
HHS Definitions for Protection of Human Research Subjects
- D.
Documentation of Informed Consent
- 56.
- 57.What is the FDA form 482 for?
- A.
Notice of Inspection
- B.
Findings of Inspection
- C.
Declaration of Financial Interests and Arrangements
- D.
Certification of Financial Interests and Arrangements
- 58.In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered __________________.
- 59.A sponsor my transfer responsibility for any of all of the obligations to a _______.
- 60.The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _______ following the study's completion.
- 61.The contract research organization shall select a monitor that is _______.
- A.
Qualified by experience
- B.
Is located close to the sites
- C.
Qualified by training
- D.
Option4
- 62.Before the investigation begins, the sponsor shall give each participation clinical investigator a/an _____.
- 63.A ________ lists the investigator’s education, training, and experience that qualifies the investigator as an expert in the clinical investigation of the drug for the use under investigation.
- A.
Curriculum vitae
- B.
Letter from a fellow investigator
- C.
Statement of qualifications of the investigator
- D.
A and C
- 64.The sponsor shall monitor investigations to identify when an IRB determines that it cannot approve the research because it does not meet the criteria for exception or because of other relevant ethical concerns.
- A.
True
- B.
False
- 65.The minimum number of Institutional Review board (IRB) members is:
- A.
3
- B.
12
- C.
5
- D.
7
- 66.Type question here. Example: Practice makes you [Blank]
- 67.The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new dosage would be?
- A.
77
- B.
97
- C.
91
- D.
85
- 68.The responsibility for ensuring that the investigator understands a clinical trial lies with:
- A.
The FDA
- B.
The IRB
- C.
The Sponsor
- D.
Option4
- 69.A purpose of monitoring clinical trials is to verify that:
- A.
A. The rights, safety, and well-being of human subjects are protected
- B.
B. Investigators receive adequate payment for their participation in the clinical trial
- C.
C. The investigator has received annual reports from the sponsor
- D.
D. The regulatory agency has received all case history information of subjects enrolled on the clinical trial
- 70.A drug’s safety is determined by which of the following criteria?
- A.
C. The Food and Drug Administration’s (FDA) review of source documentation at a clinical site
- B.
B. The absence of harmful side effects on the individuals exposed so far
- C.
A. The dose at which no side effects are reported
- D.
Option4
- 71.Which of the following statements best defines the term “efficacy” in a clinical trial?
- A.
The best possible outcome of a clinical trial
- B.
The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease
- C.
C. A determination proving there is a statistically significant difference in the pharmacokinetic effect of the study drug versus placebo
- D.
Option4
- 72.Which of the following terms is best defined as “a pharmaceutical preparation that contains no active agent”?
- A.
Blinded
- B.
Non Invasive
- C.
Placebo
- 73.Which of the following design methods would best be used for a study interested in keeping both the subject and the investigator (or site staff) from knowing which treatment the subject was receiving?
- A.
Double Blinded
- B.
Interpretive Bias
- C.
Bias Reduction
- D.
Phase 1
- 74.Which person(s) or agency would not be informed of the treatment assignment for a given subject in a study that was using a single blind method randomization?
- A.
The subject
- B.
Treating clinician/research team
- C.
FDA
- 75.Which of the following responsibilities falls under the jurisdiction of the Food and Drug Administration (FDA)?
- A.
Approval of individual study sites in clinical trials
- B.
Direct management of clinical trials
- C.
Oversight of regulation adherence in clinical trials
- D.
Option4
- 76._______Means any board, committee, or other group formally designated by an institution to review biomedical research involving subjects
- 77.CBER stands for ____
- A.
Center for Biologics Evaluation and Review
- B.
Center for Biological Evaluation and Research
- C.
Center for Biologics Evaluation and Review
- D.
Center for Biologics Evaluation and Research
- 78.The sponsor shall notify the FDA by telephone or fax any unexpected fatal or life-threatening experience associated with the use of the drug as soon as possible but no later than _____ after the sponsor’s initial receipt of the information
- 79.IDE stands for _____
- 80.Only the principle investigator is allowed to transcribe data from the source document to the CRF?
- A.
True
- B.
False
- 81.The contents of a Protocol should generally contain:
- A.
Trial objectives and purpose
- B.
Assessment of efficacy
- C.
Data handling and record keeping
- D.
All of the above
- 82.What date should an investigator write when he failed to sign the consent form on the date of consent?
- A.
Date of consent
- B.
Date of investigator’s signature
- C.
One day after date of consent
- D.
Option4
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