SOCRA Certification Exam! Trivia Quiz
(65).jpg "SOCRA Certification Exam! Trivia Quiz - Quiz")
In order to understand the disease and the effect of a certain group of medicines have on it, there have to be some clinical trials ran and SOCRA is put in place to protect the welfare of research participants. This is a review of the code of federal regulations- protecting human subjects. Just to help with reviewing for The SOCRA exam. Give it a shot!
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 serves as a summary of the information included in the IND application, providing an overview of the study protocol, the drug's composition, manufacturing details, and the proposed clinical trials. It also includes information about the sponsor, the investigator, and the institutional review board (IRB) overseeing the study. The FDA uses this form to quickly assess the key details of the IND application before conducting a thorough review.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 Investigational New Drug application. This regulation outlines the requirements for the submission and approval of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The IND application is submitted by sponsors or investigators who wish to conduct clinical trials with new drugs or biologics in humans. It includes information on the drug's composition, manufacturing, preclinical data, and proposed clinical trial protocols. The FDA reviews the IND application to ensure that the proposed clinical trials are safe and ethical before allowing them to 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
An investigational new drug refers to a new drug or biological drug that is being used in a clinical investigation. This means that it is a drug that is being tested in humans for the first time to evaluate its safety, efficacy, and potential side effects. It is an important step in the drug development process before a drug can be approved for commercial use. Test marketing new drugs is not the correct definition as investigational new drugs are specifically used in clinical investigations. The method of labeling bottles of medication with unknown side effects is unrelated to the definition of investigational new drug.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 the legal restrictions on its use and the need for further research. This label helps ensure that the drug is not used inappropriately or without proper oversight.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 FDA form 1571 is used for submitting an Investigational New Drug (IND) application to the FDA. This form includes various information about the sponsor, the clinical investigation, and the drug being studied. The approved informed consent document is not listed on FDA form 1571 because it is not a part of the application itself. The informed consent document is a separate document that is provided to study participants to ensure that they are fully informed about the study and give their voluntary consent to participate.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 adverse 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 treated immediately. It is considered more serious than a serious adverse drug experience, as it poses an immediate threat 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 is a document that outlines ethical principles and guidelines for conducting research involving human subjects. It emphasizes three main principles: beneficence, which refers to the obligation to maximize benefits and minimize harm; respect for persons, which involves treating individuals autonomously and protecting those with diminished autonomy; and justice, which ensures fairness in the distribution of benefits and burdens of research. These principles serve as a framework to guide researchers and protect the rights and welfare of participants.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 or research studies are treated ethically and their rights and welfare are safeguarded. It outlines the informed consent process, requiring researchers to provide participants with all relevant information about the study, its risks, and benefits before they can voluntarily decide to participate. Additionally, it establishes guidelines for the involvement of vulnerable populations, such as children or prisoners, to ensure their specific needs and rights are protected.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 section outlines the additional protections and considerations that must be taken into account to ensure the safety and well-being of child participants. It covers aspects such as obtaining informed consent from parents or guardians, assent from the children themselves, and the requirement for the research to have a favorable risk-benefit ratio for the participants. This subpart aims to protect the rights and welfare of children involved in research studies.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 clinical trials and aims to determine the appropriate dosage and potential side effects. Compared to Phase II and III, Phase I protocols are less complex and detailed as they primarily focus on initial safety evaluations rather than efficacy or effectiveness assessments.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". The question states that a sponsor will not ship a study drug until they have received all of the listed documents, which includes 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. Therefore, all of these documents must be received before the sponsor will ship the study drug.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
The correct answer is Form 3454 because the question is asking for an alternative name for the "Certification of absence of financial interest". The answer provided, Form 3454, is the alternative name for the certification.Rate this question:
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