SOCRA CCRP Practice Exam
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Prepare effectively for the SOCRA CCRP exam with our Practice Exam Quiz. SOCRA stands for Society of Clinical Research Associates, and CCRP denotes Certified Clinical Research Professional. This quiz is designed to simulate the real exam experience and assess your readiness. It covers essential topics in clinical research, making it ideal for individuals seeking certification or professionals looking to reinforce their knowledge. Test your understanding, identify areas for improvement, and boost your confidence with our comprehensive quiz. Whether you're a novice or experienced professional, this quiz will help you achieve success in the field of clinical research.
SOCRA CCRP Practice Exam Questions and Answers
- 1.
*The responsibility for ensuring that the investigator understands a clinical trial lies with:
- A.
FDA
- B.
IRB
- C.
Sponsor
- D.
Coordinator
Correct Answer
C. SponsorExplanation
The sponsor is responsible for ensuring that the investigator understands a clinical trial. This includes providing the necessary information and training to the investigator, as well as ensuring that the investigator is aware of and follows all applicable regulations and guidelines. The sponsor also plays a role in monitoring the progress of the trial and addressing any issues or concerns that may arise.Rate this question:
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- 2.
*What is the minimum number of IRB members?
- A.
3
- B.
5
- C.
6
- D.
10
Correct Answer
B. 5Explanation
The minimum number of IRB members is 5 because having a minimum of 5 members ensures diversity and represents different perspectives and expertise. This allows for comprehensive review and evaluation of research proposals, ensuring ethical considerations are adequately addressed. With fewer than 5 members, there may not be enough diversity and expertise to effectively assess the ethical implications of the research.Rate this question:
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- 3.
*Significant risk device is defined as an investigational device that is:
- A.
Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.
- B.
Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject.
- C.
For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.
- D.
All the above
Correct Answer
D. All the aboveExplanation
The correct answer is "All the above" because all three options listed in the question describe the criteria for a device to be considered a significant risk device. A significant risk device is one that is intended as an implant and presents a potential for serious risk to the subject's health, safety, or welfare, or is purported to be for a use in supporting or sustaining human life and presents a potential risk, or is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk.Rate this question:
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- 4.
*With respect to IRB/IEC membership, both the FDA and the ICH require that
- A.
A majority of the members' primary area of interest is in a scientific area
- B.
At least one member holds a Ph.D. degree or equivalent
- C.
At least one member's primary area of interest is in a nonscientific area
- D.
A majority of the members are from or have ties to the institution of record
Correct Answer
C. At least one member's primary area of interest is in a nonscientific areaExplanation
Both the FDA and the ICH require that at least one member's primary area of interest is in a nonscientific area. This means that there should be at least one member on the IRB/IEC whose expertise is not solely focused on scientific matters. This requirement ensures that the review board has a diverse range of perspectives and can consider the ethical, social, and cultural implications of the research being conducted. It helps to prevent any potential biases or conflicts of interest that may arise if all members have a purely scientific background.Rate this question:
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- 5.
*In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval?
- A.
The investigator provides his/her written approval
- B.
The study drug has an FDA approved marketing application
- C.
The FDA provides written approval of the IND
- D.
Subjects cannot be enrolled until IRB/IEC approval has been obtained
Correct Answer
D. Subjects cannot be enrolled until IRB/IEC approval has been obtainedExplanation
In a non-emergency situation, subjects cannot be enrolled into a study prior to IRB/IEC approval. This means that even if the investigator provides their written approval or if the study drug has an FDA approved marketing application, subjects still cannot be enrolled until the necessary IRB/IEC approval has been obtained. The FDA providing written approval of the IND also does not allow for subjects to be enrolled prior to IRB/IEC approval.Rate this question:
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- 6.
*A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct?
- A.
This subject does not need to undergo any of the study procedures since the subject is enrolled on the non-treatment arm
- B.
This subject should undergo all study procedures as outlined in the protocol
- C.
This subject only needs to undergo the study procedures that pertain specifically to the subject
- D.
This subject can undergo the study procedures whenever it is convenient
Correct Answer
B. This subject should undergo all study procedures as outlined in the protocolExplanation
The correct answer is that this subject should undergo all study procedures as outlined in the protocol. Regardless of being randomized to the non-treatment arm, the protocol states that all subjects should undergo the study procedures within one week of enrollment. Therefore, this subject is still required to follow the protocol and complete all study procedures.Rate this question:
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- 7.
*A purpose of monitoring clinical trials is to verify that:
- A.
The rights, safety, and well-being of human subjects are protected
- B.
Investigators receive adequate payment for their participation in the clinical trial
- C.
The investigator has received annual reports from the sponsor
- D.
The regulatory agency has received all case history information of subjects enrolled on the clinical trial
Correct Answer
A. The rights, safety, and well-being of human subjects are protectedExplanation
The purpose of monitoring clinical trials is to ensure that the rights, safety, and well-being of human subjects are protected. This involves regularly assessing and evaluating the trial to identify any potential risks or adverse events that may occur during the study. Monitoring also ensures that the trial is being conducted in accordance with ethical guidelines and regulatory requirements to minimize any harm to the participants. By verifying that these protections are in place, the monitoring process helps to maintain the integrity and validity of the clinical trial.Rate this question:
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- 8.
*Which of the following is the proper way to make a correction to a CRF?
- A.
Completely blacken the incorrect entry and then enter the correct information
- B.
Back date the corrected entry with the date of the original entry
- C.
Initial using the initials of the sponsor’s representative who reviewed the change
- D.
Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change
Correct Answer
D. Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the changeExplanation
To make a correction to a CRF, the proper way is to add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change. This ensures that the correction is properly documented and attributed to the person responsible for making the change. It also provides clarity and transparency regarding the reason for the correction, if needed.Rate this question:
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- 9.
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
Correct Answer
A. TrueExplanation
The ICH GCP Guideline aims to establish a common standard for clinical data acceptance by regulatory authorities in the EU, Japan, and the United States. By providing a unified framework, it facilitates the mutual recognition and acceptance of clinical data across these jurisdictions. This helps streamline the regulatory process, ensuring that clinical trials conducted in these regions meet consistent quality standards and can be relied upon for decision-making purposes. Therefore, the statement "True" accurately reflects the objective of the ICH GCP Guideline.Rate this question:
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- 10.
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
- E.
Only A & C
Correct Answer
D. All of the aboveExplanation
The contents of a protocol should generally include the trial objectives and purpose, assessment of efficacy, and data handling and record keeping. Including the trial objectives and purpose helps to clearly define the goals and intentions of the study. Assessment of efficacy is crucial in determining the effectiveness of the intervention being studied. Data handling and record keeping ensure that all data collected during the trial is properly documented and organized for analysis. Therefore, all of the above options are necessary components of a protocol.Rate this question:
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- 11.
Only the principal investigator is allowed to transcribe data from the source document to the CRF?
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
False. The principle investigator is not the only person allowed to transcribe data from the source document to the CRF. Other trained and authorized personnel, such as research assistants or data managers, may also be involved in this process. The principle investigator may oversee the data transcription, but it is not exclusively their responsibility.Rate this question:
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- 12.
When a short form is used for Informed Consent, the witness must sign either the short form or the summary.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
According to regulations and best practices, the witness must sign both the short form and the summary when a short form is used for informed consent.Here's a breakdown of the correct process:Short Form: The short form is a translated document summarizing the essential elements of informed consent in the subject's preferred language.Written Summary: This is a detailed document in English that outlines all aspects of the informed consent process.Witness: An individual (over 18, fluent in both languages, not involved in the study) witnesses the researcher obtaining consent from the subject.Signing: After the subject understands and agrees to participate, they sign the short form. The witness then signs both the short form and the written summary to confirm they witnessed the process and the subject's agreement.Therefore, it's crucial for both the short form and the summary to be signed by the witness for proper documentation and ethical research practice.Rate this question:
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- 13.
Form___________ is the investigator statement.
- A.
1571
- B.
1572
- C.
3500
- D.
3500A
Correct Answer
B. 1572Explanation
The correct form is Form FDA 1572. Form 1572, also known as the "Statement of Investigator," is a document that must be completed by clinical investigators participating in research studies involving investigational new drugs, biologics, or medical devices in the United States. The purpose of this form is to provide the Food and Drug Administration (FDA) with essential information about the investigator's qualifications, the study site, and the study itself. By signing Form 1572, investigators commit to conducting the study in accordance with the approved protocol, relevant regulations, and Good Clinical Practice (GCP) guidelines. This form plays a crucial role in ensuring the ethical conduct of clinical trials and the protection of human subjects.Rate this question:
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- 14.
What is 45 CFR Part 46?
- A.
HHS - Protection of Human Subjects
- B.
FDA - Protection of Human Subjects
- C.
HHS - Protection of Children
- D.
HHS - Protection of Research Participants
Correct Answer
A. HHS - Protection of Human SubjectsExplanation
45 CFR Part 46 refers to the Code of Federal Regulations (CFR) that outlines the protection of human subjects in research activities conducted or supported by the U.S. Department of Health and Human Services (HHS). Specifically, it is titled "Protection of Human Subjects." These regulations are based on the ethical principles outlined in the Belmont Report and provide a framework for the conduct of research involving human subjects. The regulations cover various aspects of research, including the requirement for Institutional Review Board (IRB) review and approval, informed consent procedures, and the protection of vulnerable populations, such as children, pregnant women, and prisoners. Compliance with 45 CFR Part 46 is essential for institutions and researchers involved in HHS-funded or conducted research to ensure the ethical treatment and safety of human subjects.Rate this question:
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- 15.
The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR812.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
The statement is false. The Code of Federal Regulations that applies to Investigational New Drug (IND) Applications is 21 CFR Part 312, not 21 CFR 812. 21 CFR Part 312 provides the regulations and guidelines for obtaining and maintaining an IND, which is required for the study of investigational new drugs in the United States. This part covers the requirements for submitting an IND application, the responsibilities of sponsors and investigators, the protection of human subjects, and the monitoring and reporting of adverse events, among other topics. Compliance with these regulations is crucial for ensuring the ethical conduct of clinical trials and the safety of participants involved in the testing of new drug candidates.Rate this question:
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- 16.
Who monitors the progress of all clinical trial investigations being conducted under an IND?
- A.
Principal Investigator
- B.
IRB
- C.
Sponsor
- D.
CRO
Correct Answer
C. SponsorExplanation
The sponsor is responsible for monitoring the progress of all clinical trial investigations being conducted under an IND. They oversee the trial and ensure that it is being conducted according to the protocol, regulations, and ethical guidelines. The sponsor is typically a pharmaceutical company, government agency, or academic institution that initiates and funds the clinical trial. They play a crucial role in ensuring the safety and efficacy of the investigational product and have the ultimate responsibility for the trial's success.Rate this question:
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- 17.
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 Nuremberg Code
- D.
The Declaration of Helsinki
Correct Answer
D. The Declaration of HelsinkiExplanation
The Declaration of Helsinki is a set of ethical principles for medical research involving human subjects, established by the World Medical Association (WMA). It provides guidelines for researchers to ensure the protection and well-being of human participants in research studies. The Belmont Report, the National Research Act, and the Nuremberg Code are also important documents related to research ethics, but they are not specifically associated with the WMA or medical research involving human subjects.Rate this question:
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- 18.
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 Practices (GCP)
- C.
The Declaration of Helsinki
- D.
Fundamental Ethical Principles (FEP)
Correct Answer
B. Good Clinical Practices (GCP)Explanation
Good Clinical Practices (GCP) is the international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects. GCP ensures that the rights, safety, and well-being of the participants are protected and that the data generated from the trials are reliable and credible. It provides guidelines on the ethical considerations, study design, participant recruitment, informed consent process, data collection and management, safety monitoring, and reporting of results. GCP is widely recognized and followed by regulatory authorities, research institutions, and pharmaceutical companies to ensure the highest standards of research integrity and participant protection.Rate this question:
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- 19.
The Code of Federal Regulations that applies to Institutional Review Boards is:
- A.
45CFR46
- B.
21CFR312
- C.
21CFR50
- D.
21CFR56
Correct Answer
D. 21CFR56Explanation
The correct answer is 21CFR56 because it refers to the Code of Federal Regulations that applies to Institutional Review Boards. The other options, 45CFR46, 21CFR312, and 21CFR50, do not specifically pertain to Institutional Review Boards.Rate this question:
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- 20.
This form is used for the voluntary reporting of adverse events and product problems:
- A.
1571
- B.
1572
- C.
3500
- D.
3500A
Correct Answer
C. 3500Explanation
The correct form is Form FDA 3500. Form FDA 3500, also known as the "Voluntary Adverse Event Report," is used by healthcare professionals, consumers, and patients to voluntarily report adverse events and product problems related to drugs, biologics, medical devices, dietary supplements, and other FDA-regulated products. Reporting adverse events can help the FDA identify potential safety concerns, monitor product safety, and take appropriate actions to protect public health, such as issuing warnings or requiring label changes.Rate this question:
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- 21.
Each IRB that reviews studies involving children as subjects is covered by:
- A.
21CFR 56, Subpart A
- B.
21CFR 56, Subpart B
- C.
21CFR 50, Subpart D
- D.
21CFR 56, Subpart C
Correct Answer
C. 21CFR 50, Subpart DExplanation
21 CFR 50, Subpart D- This section specifically provides "Additional Safeguards for Children in Clinical Investigations." It includes provisions that ensure extra protection for children involved in research, encompassing all necessary regulatory aspects to safeguard children’s welfare in clinical studies.Rate this question:
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- 22.
This form is used for the mandatory reporting of serious adverse events:
- A.
1571
- B.
1572
- C.
3500
- D.
3500A
Correct Answer
D. 3500AExplanation
Form FDA 3500A is used for the mandatory reporting of serious adverse events, product problems, and medication errors associated with FDA-regulated products, such as drugs, biologics, and medical devices. This form is primarily intended for use by healthcare professionals, healthcare facilities, manufacturers, and importers to report serious events that occur during the use of these products. Reporting such events is essential to help the FDA monitor product safety, identify potential risks, and take appropriate actions to protect public health, including product label changes, safety warnings, or product recalls.Rate this question:
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- 23.
What is covered in 21CFR50 Subpart B?
- A.
Informed consent of Human Subjects
- B.
IRB Functions and Operations
- C.
Records and Reports
- D.
Additional Safeguards for Children in Clinical Investigations
Correct Answer
A. Informed consent of Human SubjectsExplanation
21CFR50 Subpart B covers the informed consent of human subjects. This means that it includes the regulations and guidelines related to obtaining informed consent from individuals who participate in clinical investigations. Informed consent ensures that participants are fully aware of the purpose, risks, and benefits of the study before they decide to participate. It also ensures that participants have the right to withdraw from the study at any time. This subpart outlines the specific requirements and procedures that must be followed to obtain informed consent from human subjects.Rate this question:
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- 24.
*The IRB must determine that requirements for permission by parents or guardians and assent by children are met.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
True. The IRB ensures that parental/guardian permission and child assent requirements are met in pediatric research, as per federal regulations. These requirements vary based on the research risk level and the child's age, helping to protect children's rights, safety, and well-being while considering their developmental and emotional needs.Rate this question:
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- 25.
What topic is covered in 45CFR46 Subpart B?
- A.
Additional Safeguards and Protections
- 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
Correct Answer
D. Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in ResearchExplanation
45 CFR 46 Subpart B, titled "Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research," specifically addresses the ethical guidelines and additional safeguards and protections for research involving pregnant women, human fetuses, and neonates. This subpart outlines the regulatory requirements and considerations to ensure the well-being and safety of these vulnerable populations when they participate in research studies. It includes detailed rules and procedures to protect the rights and welfare of pregnant women and their unborn fetuses, as well as neonates involved in research activities.Rate this question:
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- 26.
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.
- A.
6 months
- B.
1 year
- C.
2 years
- D.
5 years
Correct Answer
B. 1 yearExplanation
The clinical investigator is required to update the financial disclosure information if any relevant changes occur during the investigation's course and for 1 year following the study's completion. This is important to ensure transparency and integrity in the research process and to identify any potential conflicts of interest that may arise. By updating the financial disclosure information for 1 year, it allows for a sufficient period of time to capture any changes that may occur after the study has ended.Rate this question:
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- 27.
The 3 fundamental ethical principles for human subjects' in research are:
- A.
Respect for persons, beneficence, justice
- B.
Respect for subjects, their safety and their time
- C.
Respect for sponsor, IRB and FDA guidelines
- D.
Respect for data, welfare and discovery
Correct Answer
A. Respect for persons, beneficence, justiceExplanation
The 3 fundamental ethical principles for human subjects in research are respect for persons, beneficence, and justice. These principles emphasize the importance of treating individuals with dignity and autonomy, ensuring their well-being and minimizing harm, and promoting fairness and equity in the distribution of research benefits and burdens. By adhering to these principles, researchers can ensure that their studies are conducted ethically and that the rights and welfare of the participants are protected.Rate this question:
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- 28.
*Each IRB that uses an expedited review procedure must adopt a method for keeping all members advised of research proposals which have been approved under the expedited review procedure _________.
- A.
45 CFR 46.110; CFR 56.110(c)
- B.
45 CFR 46.110(d); 21 CFR 56.110
- C.
45 CFR 46.110(c); 21 CFR 56.110(c)
- D.
45 CFR 46.110(b); 21 CFR 56.110(c)
Correct Answer
C. 45 CFR 46.110(c); 21 CFR 56.110(c)Explanation
45 CFR 46.110(b); 21 CFR 56.110(c)
This reference indicates the regulatory requirements that Institutional Review Boards (IRBs) must follow when utilizing expedited review procedures, including the method for keeping all IRB members informed about research proposals approved through this process.Rate this question:
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- 29.
*In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were _________.
- A.
Expected
- B.
Serious
- C.
Would have implications for the conduct of the study
- D.
B & C
- E.
A, B & C
Correct Answer
D. B & CExplanation
An adverse event (AE) observed during a study should be considered an unanticipated problem involving risk to human subjects and reported to the IRB if it is serious and would have implications for the conduct of the study. This means that if the AE is both serious and would affect the study, it should be reported to the IRB. The answer B & C correctly identifies these criteria.Rate this question:
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- 30.
Once the sponsor evaluates data from a clinical trial and decides the drug presents an immeasurable and significant risk to the subjects; the sponsor has _____________ to discontinue the study.
- A.
24 hours
- B.
48 hours
- C.
3 WD
- D.
5 WD
Correct Answer
D. 5 WDExplanation
Although the specific regulations may vary by country and regulatory body, a common timeframe for a sponsor to report significant safety issues and make necessary changes to a clinical trial, including discontinuation, is within 5 working days (WD). In the event that a drug presents an immeasurable and significant risk to the subjects, the sponsor should work expeditiously to gather the necessary information and notify the appropriate parties, such as ethics committees and regulatory authorities, within this timeframe. The sponsor should also take prompt action to protect the safety and well-being of the subjects, which may include discontinuing the study or making significant modifications to the protocol.Rate this question:
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- 31.
A Short Form informed consent is a written summary of the ICF that is not to exceed one page.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
The statement is false. Although a Short Form informed consent is indeed a written summary of the full informed consent form (ICF), it is not necessarily limited to one page. The purpose of a Short Form informed consent is to provide a simplified, easily understandable version of the full ICF, focusing on the key information that potential research subjects need to make an informed decision about participating in a study.The Short Form typically includes a description of the study's purpose, procedures, risks, and benefits, as well as the subject's rights and responsibilities. It may also include contact information for the investigator or research team and a statement that the subject voluntarily agrees to participate.The Short Form informed consent is often used in situations where the full ICF is too complex or lengthy for the target population, such as when working with individuals who may have difficulty understanding the full document due to language barriers, cognitive impairments, or other factors. The Short Form must be accompanied by an oral presentation of the complete informed consent information, and a witness should be present to attest that the oral presentation occurred and that the subject understood the information. Both the subject and the witness must sign the Short Form to document their agreement to participate in the research.Rate this question:
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- 32.
Identify the manner in which the informed consent form (ICF) can be presented to the subject.
- A.
ICF can be read to the subject of the LAR
- B.
ICF is handed to the subject to read and sign on their own in private
- C.
ICF is delivered via FedEx with a return stamped envelope
- D.
ICF must be delivered to the subject or LAR electronically with a read receipt requested
Correct Answer
B. ICF is handed to the subject to read and sign on their own in privateExplanation
Informed consent is typically provided to the subject in a manner that allows them to review the document privately, ensuring they have adequate time to understand the information presented before signing it.Rate this question:
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- 33.
When using the short form informed consent, the witness and the person actually obtaining the consent from the subject shall each sign the short form in addition to the summary.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
Study 21 CFR 50.27 (2) -The witness shall sign BOTH the short form and summary. Person actually obtaining consent shall sign ONLY a copy of the summary. (Subject ONLY has to sign the short form).Rate this question:
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- 34.
Per 21 CFR Part 312, the sponsor must notify FDA and all participating investigators in an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
Study 21 CFR 312.32(c)(1)Rate this question:
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- 35.
During the clinical trial, regulations require that a subject be given the right to...
- A.
Travel
- B.
Withdraw at any time
- C.
Get financial compensation
- D.
Speak to a sponsors attorney
Correct Answer
B. Withdraw at any timeExplanation
During a clinical trial, regulations require that a subject be given the right to withdraw at any time. This is because participation in a clinical trial is voluntary, and subjects should have the freedom to discontinue their involvement if they wish to do so. This right ensures that subjects are not coerced or forced to continue participating against their will. It also prioritizes their autonomy and allows them to make decisions about their own health and well-being.Rate this question:
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- 36.
Which signatures are required by FDA regulation to be on the consent form?
- A.
The investigator
- B.
The subject
- C.
The investigator and the suject
- D.
The subject and a witness
Correct Answer
B. The subjectExplanation
FDA regulations require only the subject's (or their legally authorized representative's) signature on the consent form. The signature indicates voluntary agreement to participate after receiving the necessary information. In practice, the investigator often signs as well, confirming they explained the study and obtained informed consent.Rate this question:
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- 37.
According to 21 CFR 312.56, if a sponsor finds an investigator is non-compliant with a clinical protocol or approved investigational plan, the sponsor must:
- A.
Report the investigator to the IRB once it becomes aware
- B.
Bring the investigator into compliance
- C.
Immediately close that investigators site
- D.
None of the above
Correct Answer
B. Bring the investigator into complianceExplanation
According to 21 CFR 312.56, if a sponsor finds an investigator to be non-compliant with a clinical protocol or an approved investigational plan, the sponsor must:Bring the investigator into complianceThe regulation requires the sponsor to ensure that the investigator either complies with the protocol or provides a sufficient explanation for the deviation. The sponsor may terminate the investigator's participation if compliance cannot be achieved. Reporting the investigator to the IRB or closing the investigator's site might be necessary steps, but the primary action required by the regulation is to bring the investigator into compliance.Rate this question:
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- 38.
Minimal risk is defined as "the magnitude of harm that a subject would encounter is not exceeded by those ordinarily encountered in daily life".
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The statement is true because minimal risk refers to the level of harm that a subject may encounter during a study, and this harm should not exceed the risks that individuals typically face in their everyday lives. In other words, the potential harm to participants should be no greater than what they would normally encounter in their daily activities. This ensures that the study does not pose an excessive risk to the participants' well-being.Rate this question:
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- 39.
In accordance with regulations, before implementation, the informed consent document must be approved by the:
- A.
Sponsor
- B.
Investigator
- C.
IRB or IEC
- D.
A, B & C
- E.
B & C only
Correct Answer
C. IRB or IECExplanation
In accordance with regulations, the informed consent document must be approved by the IRB (Institutional Review Board) or IEC (Independent Ethics Committee). These bodies are responsible for reviewing research protocols and ensuring that the rights and welfare of study participants are protected. The sponsor and investigator may also be involved in the approval process, but the ultimate authority lies with the IRB or IEC. Therefore, the correct answer is IRB or IEC.Rate this question:
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- 40.
Proper preparations should be made and adequate facilities provided to protect the experimental subject against even the remotest possibility of
- A.
Injury and hospitalization
- B.
Financial hardship
- C.
Concern
- D.
Injury, disability or death
Correct Answer
D. Injury, disability or deathExplanation
It is important to make proper preparations and provide adequate facilities to protect the experimental subject from any harm or danger. This includes ensuring their safety and well-being to prevent any possibility of injury, disability, or even death. The answer choice "Injury, disability or death" encompasses the most severe consequences that could potentially occur if proper precautions are not taken.Rate this question:
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- 41.
After completion of the investigation, sponsor shall provide the investigator with a final report.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The statement is true. After the completion of a clinical investigation, the sponsor is required to provide the investigator with a final report. This report should include a summary of the study's findings, conclusions, and any relevant statistical analyses. The purpose of sharing the final report with the investigator is to ensure transparency, allow the investigator to review the study's outcomes, and provide them with the necessary information for potential future research or publications. This practice is in line with Good Clinical Practice (GCP) guidelines, which emphasize the importance of communication and collaboration between sponsors and investigators throughout the entire research process.Rate this question:
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- 42.
Per 21 CFR Part 312, who is required to sign a 1572 Statement of Investigator form?
- A.
The investigator
- B.
The coordinator
- C.
The investigator and the coordinator
- D.
Anyone substantially involved in the study
Correct Answer
A. The investigatorExplanation
Per 21 CFR Part 312, the investigator is required to sign the 1572 Statement of Investigator form. This form, officially known as Form FDA 1572, is a crucial document for clinical trials involving investigational new drugs, biologics, or medical devices in the United States. By signing Form 1572, the investigator commits to conducting the study according to the approved protocol, relevant regulations, and Good Clinical Practice (GCP) guidelines. The form also collects essential information about the investigator's qualifications, the study site, and the study itself. While the investigator is the primary individual required to sign the form, other members of the research team, such as study coordinators, may also be involved in providing relevant information or supporting the investigator throughout the study. However, the responsibility for signing the 1572 Statement of Investigator form ultimately lies with the investigator.Rate this question:
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- 43.
A request to export an investigational drug from the U.S. must include
- A.
The quantity of drug to be shipped per shipment and the frequency of expected shipments.
- B.
Adequate information about the drug to satisfy the FDA that the drug is appropriate for the proposed investigational use in animals.
- C.
A statement that the drug will be used for investigational purposes only and that the drug may be legally used by that consignee in the importing country for the proposed use.
- D.
A & C only
- E.
All of the above
Correct Answer
E. All of the aboveExplanation
The correct answer is "All of the above." A request to export an investigational drug from the United States must include the following information:The quantity of the drug to be shipped per shipment and the frequency of expected shipments. This helps the FDA understand the scope and scale of the export.Adequate information about the drug to satisfy the FDA that the drug is appropriate for the proposed investigational use in animals. This might include data on the drug's pharmacology, toxicity, and any available clinical data to support its safety and potential efficacy for the intended use.A statement that the drug will be used for investigational purposes only and that the drug may be legally used by the consignee in the importing country for the proposed use. This ensures that the drug is being exported for legitimate research purposes and that it complies with the regulations of the importing country.Providing this information in the export request is essential to comply with FDA regulations and facilitate the approval process for shipping investigational drugs outside the United States.Rate this question:
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- 44.
FDA may waive any of the requirements contained in the regulations, including the requirements for IRB review.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The FDA can waive regulations, including IRB review, if it's in the public's best interest or necessary to protect subjects' rights and welfare. This might occur in emergencies where IRB review delays treatment for life-threatening conditions. The FDA considers various factors to ensure ethical principles are maintained and subjects' rights are safeguarded. Waivers are granted cautiously to maintain the integrity of research and participant safety.Rate this question:
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- 45.
The Code of Federal Regulations part 50, 56 and 312 (among others) are designed to ensure the safety of clinical testing and the safety of products following a marketing approval.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The statement is true. The Code of Federal Regulations (CFR) parts 50, 56, and 312 play a crucial role in ensuring the safety of clinical testing and the safety of products following marketing approval in the United States.Part 50: This part outlines the general requirements for informed consent and the protection of human subjects in clinical research, ensuring that participants understand the risks and benefits of a study before making an informed decision to participate.Part 56: This part covers the regulations for Institutional Review Boards (IRBs), which are responsible for reviewing, approving, and monitoring clinical research studies to ensure the protection of human subjects.Part 312: This part pertains to the regulations for Investigational New Drug Applications (INDs), which are required for initiating clinical trials of new drugs and biologics. Part 312 ensures the safety of participants involved in these trials by outlining the responsibilities of sponsors, investigators, and the FDA, as well as the requirements for informed consent and reporting of adverse events.Together, these regulations form the foundation of the FDA's commitment to protecting human subjects participating in clinical trials and ensuring the safety of products entering the market. Compliance with these regulations is essential for conducting ethical and responsible clinical research.Rate this question:
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- 46.
The Food and Drug Adminisrtation (FDA) conducts drug risk assessment by considering which of the following?
- A.
There are a sufficient number of people needing the drug.
- B.
The benefits of the drug outweigh the known and potential risk of the drug
- C.
The side-effects of the drug is measurable
- D.
The sponsor is able to financially support the research
Correct Answer
B. The benefits of the drug outweigh the known and potential risk of the drugExplanation
The Food and Drug Administration (FDA) conducts drug risk assessment by primarily evaluating if the benefits of the drug outweigh the known and potential risks associated with its use. This assessment is crucial in the drug approval process, as the FDA must ensure that the potential benefits justify the risks for patients. The process involves analyzing data from preclinical and clinical trials, considering factors like the severity of the treated condition, alternative treatments, and the drug's impact on public health.Rate this question:
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- 47.
An investigational drug can be exported from the U.S., if
- A.
Permission is granted by Congress
- B.
The intended recipient is a US pharmacy
- C.
The importer is a foreign pharmacy inspected and approved by the FDA
- D.
Approval is granted after a written request is submitted to the FDAs International Affairs Staff Associate Commissioner.
- E.
The drug is for investigational use only and goes directly to a potential patient
Correct Answer
D. Approval is granted after a written request is submitted to the FDAs International Affairs Staff Associate Commissioner.Explanation
The correct answer is "Approval is granted after a written request is submitted to the FDAs International Affairs Staff Associate Commissioner." This means that in order for an investigational drug to be exported from the U.S., a written request must be submitted to the FDAs International Affairs Staff Associate Commissioner and approval must be granted. This suggests that there is a regulatory process in place to ensure that the exportation of investigational drugs is done in a controlled and monitored manner.Rate this question:
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- 48.
Emergency use of a test article is exempt from the requirement for IRB review, provided that such emergency use is reported to the IRB in writing within 5 calendar days.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
21 CFR 56.104(c) states that an IRB review can be waived in the case of emergency use of a test article if there is no time to use existing procedures for obtaining IRB approval. However, subsequent to the emergency use, the physician must inform the IRB. This notification should include a summary of the conditions that led to the emergency use, and typically, it must be reported promptly, but the regulation does not specify the "5 calendar days" as the hard deadline in all scenarios.
While it is common practice for hospitals and institutions to set internal rules requiring reporting within 5 days (or even immediately following the use), this specific timeframe is not a federal regulatory requirement under 21 CFR 56.104(c). Reporting requirements can vary based on the institution's policy governed by their specific IRB protocols.
Therefore, the correct response based on precise regulatory language would be False because the statement misrepresents the universal regulatory requirement by specifying a "5 calendar days" timeframe which is not explicitly stated in the federal regulations.Rate this question:
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- 49.
A Clinical Hold is an order by FDA to the investigator to suspend or stop ongoing investigations.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
A Clinical Hold is an order issued by the Food and Drug Administration (FDA) to the sponsor, not the investigator, to suspend or stop ongoing clinical investigations. This action is taken when the FDA has concerns about the safety of the study participants or the integrity of the study data. A Clinical Hold can be placed on a specific study or an entire clinical program for an investigational new drug (IND) or investigational device exemption (IDE). The sponsor must address the FDA's concerns and provide adequate information to resolve the issues before the clinical hold can be lifted and the study resumed. Although investigators are not the direct recipients of the Clinical Hold order, they must comply with the suspension of the study and may need to collaborate with the sponsor to resolve the issues leading to the hold.Rate this question:
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- 50.
An IND is always required before using an investigational new drug.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
An IND isn't always needed for investigational new drugs. Exceptions include using a marketed drug for an unapproved indication without a clinical investigation, specific Phase 1 studies with approved drugs, or emergencies when no alternative therapy exists. If the drug is used in a clinical investigation to gather data for FDA marketing approval or labeling changes, an IND application is required. This process ensures proper testing and monitoring, protecting participants' safety and generating reliable data on the drug's safety and efficacy.Rate this question:
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Apr 16, 2024Quiz Edited by
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Feb 25, 2020Quiz Created by
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