For The SOCRA Exam
This is a review of the code of federal regulations- protecting human subjects. Just to help with reviewing for the SOCRA exam.
Questions and Answers
- 1.
What is FDA form 1571?
- A.
Statement of investigator
- B.
Cover sheet for Investigational New Drug application
- C.
Disclosure of financial interests of clinical investigators
- D.
Investigator's brochure application
Correct Answer
B. Cover sheet for Investigational New Drug applicationExplanation
FDA form 1571 is the cover sheet for an Investigational New Drug (IND) application. This form is required by the U.S. Food and Drug Administration (FDA) for the submission of an IND, which is a request to conduct clinical trials on a new drug or biologic product in humans. The cover sheet provides basic information about the drug, the sponsor, and the proposed clinical trials. It serves as a summary and introduction to the IND application, helping the FDA to quickly review and process the submission.Rate this question:
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- 2.
21 CFR 312 deals with
- A.
Investigational device exemptions
- B.
Protection of human subjects/ informed consent
- C.
Investigational New Drug application
- D.
IRB protocols
Correct Answer
C. Investigational New Drug applicationExplanation
21 CFR 312 deals with the Investigational New Drug (IND) application. This regulation outlines the requirements and procedures for submitting an IND application to the U.S. Food and Drug Administration (FDA) for conducting clinical trials with investigational drugs. The IND application provides information about the drug's safety and efficacy, manufacturing details, and the proposed clinical trial protocol. It is a crucial step in the drug development process, as it allows the FDA to review and evaluate the proposed clinical trials before they can proceed.Rate this question:
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- 3.
Investigational new drug means
- A.
A new drug or biological drug that is used in a clinical investigation,
- B.
The method of labeling bottles of medication with unknown side effects.
- C.
Test marketing new drugs.
Correct Answer
A. A new drug or biological drug that is used in a clinical investigation,Explanation
The correct answer is "a new drug or biological drug that is used in a clinical investigation." An investigational new drug refers to a drug or biological product that is being studied in clinical trials to determine its safety and effectiveness. It is not related to labeling bottles of medication with unknown side effects or test marketing new drugs.Rate this question:
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- 4.
The immediate package of an investigational new drug intended for human use shall bear a label with the statement
- A.
"Caution: for FDA research purposes only"
- B.
"Caution: New drug-- limited known side effects"
- C.
"Caution: New Drug-- Limited by Federal (or United States) law to investigational use."
- D.
None of the above
Correct Answer
C. "Caution: New Drug-- Limited by Federal (or United States) law to investigational use."Explanation
The correct answer is "Caution: New Drug-- Limited by Federal (or United States) law to investigational use." This statement accurately reflects the requirement for the immediate package label of an investigational new drug intended for human use. It indicates that the drug is limited by federal or United States law to investigational use only, emphasizing that it is not approved for general use or commercial distribution. This label helps ensure that the drug is used appropriately and only in authorized research settings.Rate this question:
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- 5.
Which of the following is not listed on FDA form 1571:
- A.
Name, address, phone number of the sponsor
- B.
A commitment not to start the clinical investigation until the IND is in effect
- C.
Identification of the phase of the trial
- D.
Approved informed consent document
Correct Answer
D. Approved informed consent documentExplanation
The approved informed consent document is not listed on FDA form 1571. FDA form 1571 is used for submitting an Investigational New Drug (IND) application to the FDA. This form includes information such as the name, address, and phone number of the sponsor, a commitment not to start the clinical investigation until the IND is in effect, and the identification of the phase of the trial. However, the approved informed consent document is not specifically mentioned as a requirement on this form.Rate this question:
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- 6.
"Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred" Is
- A.
Serious adverse drug experience
- B.
Life threatening adverse drug experience
- C.
None of the above
Correct Answer
B. Life threatening adverse drug experienceExplanation
A life-threatening adverse drug experience refers to any negative reaction to a drug that puts the patient or subject at immediate risk of death. This means that the reaction is severe enough to potentially cause death if not addressed promptly. It is considered more serious than a regular adverse drug experience because of the immediate risk to the patient's life.Rate this question:
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- 7.
The Belmont report consists of three main principles: beneficence, respect of persons, and ______________.
Correct Answer
justiceExplanation
The Belmont report, a fundamental document in the field of bioethics, outlines three core principles that should guide research involving human subjects. These principles are beneficence, which emphasizes the well-being and welfare of individuals, respect for persons, which emphasizes the autonomy and dignity of individuals, and justice. The principle of justice requires that the benefits and burdens of research be distributed fairly and that there should be equal access to the benefits of research. It ensures that research is conducted ethically and without discrimination, promoting fairness and equality in the research process.Rate this question:
- 8.
What phase of a drug trial usually includes hundreds to thousands of volunteers?
Correct Answer
Phase 3
Phase III
three
3Explanation
21 CFR 312 section 21Rate this question:
- 9.
The main concept of 21 CFR 50 is
- A.
IRB regulations
- B.
Protection of human subjects
- C.
Financial disclosure
- D.
Electronic records
Correct Answer
B. Protection of human subjectsExplanation
The main concept of 21 CFR 50 is the protection of human subjects. This regulation ensures that individuals participating in clinical trials and research studies are treated ethically and their rights and welfare are safeguarded. It outlines the informed consent process, requiring researchers to provide comprehensive information about the study to participants before they decide to participate. Additionally, 21 CFR 50 establishes guidelines for the involvement of vulnerable populations, such as children and prisoners, in research. Overall, the primary focus of 21 CFR 50 is to prioritize the well-being and safety of human subjects involved in research.Rate this question:
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- 10.
Subpart D of 21 CFR 50 lists the
- A.
Safe guards of children
- B.
Informed consent
- C.
Rights of prisoners as research subjects
- D.
Other not listed above
Correct Answer
A. Safe guards of childrenExplanation
Subpart D of 21 CFR 50 specifically addresses the safeguards that need to be in place when conducting research involving children. This subpart outlines the requirements for obtaining informed consent from parents or guardians, as well as assent from the children themselves when appropriate. It also emphasizes the need for additional safeguards to protect the rights and welfare of children who are participating in research, such as ensuring that the research is conducted by qualified individuals and that the risks and benefits are carefully evaluated.Rate this question:
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- 11.
The FDA may restrict, suspend, or terminate an institution's or IRB's use of the expedited review procedure when necessary to protect the rights or welfare of subjects.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
21 CFR 56 sec 110 dRate this question:
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- 12.
A Phase ________ protocol is more flexible and less detailed than the others.
- A.
I
- B.
II
- C.
III
- D.
None of the Phases are flexible.
Correct Answer
A. IExplanation
Phase I protocol is more flexible and less detailed than the others. This is because Phase I of a protocol typically involves a small number of participants and focuses on assessing the safety and tolerability of a new drug or treatment. It is usually the first step in the clinical trial process and provides preliminary information about the drug's effects. In contrast, Phase II and III protocols involve larger sample sizes and more detailed assessments of efficacy and side effects. Therefore, Phase I is considered to be more flexible and less detailed compared to the other phases.Rate this question:
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- 13.
A source document is any document found that is associated with a clinical trial.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
A source document is any document where the data are FIRST recorded.Rate this question:
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- 14.
A sponsor will not ship a study drug until they have received all of the following documents:
- A.
IRB approved protocol, IRB approved informed consent form, IRB approval letter, IRB approved recruitment materials
- B.
Signed and completed 1572, CV's and financial disclosures from everyone listed on 1572
- C.
Current lab certifications and normal ranges
- D.
A and B
- E.
All of the above
Correct Answer
E. All of the aboveExplanation
The correct answer is "All of the above." A sponsor will not ship a study drug until they have received all the mentioned documents. These documents include the IRB approved protocol, IRB approved informed consent form, IRB approval letter, IRB approved recruitment materials, signed and completed 1572, CV's and financial disclosures from everyone listed on 1572, and current lab certifications and normal ranges. All of these documents are necessary for ensuring the ethical and regulatory compliance of the study and the safety of the participants.Rate this question:
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- 15.
Certification of absence of financial interest would also be known as
- A.
Form 3455
- B.
Form 3454
Correct Answer
B. Form 3454Explanation
Form 3454 is the correct answer because it refers to the certification of absence of financial interest. This form is used to declare that an individual or organization does not have any financial interest, such as ownership or investment, in a particular entity or transaction. It is commonly used in financial and business contexts to ensure transparency and avoid conflicts of interest. Therefore, Form 3454 is the appropriate form for certifying the absence of financial interest.Rate this question:
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Current Version
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Mar 21, 2023Quiz Edited by
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Mar 01, 2012Quiz Created by
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