SOCRA CCRP Practice Exam #1
Tests on classes 1-7 material including:
- Ethics
- 21 CFR Parts 50, 56, 312 and 812
- 45 CFR Part 46
*directly from SOCRA
- 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 principle 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
Must sign both!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 investigator statement is in the form 1572.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
Title 45 CFR Part 46 covers the HHS (Health and Human Services) standards of protection of human subjects. Also referred to as Public Welfare.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
312Rate 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
Form 3500A is for MANDATORY reporting.Rate this question:
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- 21.
*Each IRB that reviews studies involving children as subjects is covered by:
- A.
21CFR Part 56, Sub part A
- B.
21CFR Part 56, Sub part B
- C.
21CFR Part 50, Sub part C
- D.
21CFR Part 56, Sub part D
Correct Answer
D. 21CFR Part 56, Sub part D -
- 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
The correct answer is 3500A because this form is specifically designed for the mandatory reporting of serious adverse events. The other options (1571, 1572, and 3500) do not serve this purpose.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
According to 45 CFR 46 and 21 CFR 50.55.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(c); 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
Section B3Rate 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
Once the sponsor evaluates data from a clinical trial and decides the drug presents an immeasurable and significant risk to the subjects, they have 5 WD (5 working days) to discontinue the study.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
Study 21 CFR 50.27.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
A. ICF can be read to the subject of the LARExplanation
The informed consent form (ICF) can be presented to the subject by reading it to the subject of the legally authorized representative (LAR). This means that someone can verbally explain the contents of the ICF to the subject or the LAR can read it out loud to the subject. This ensures that the subject understands the information and gives their consent.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
Study 21 CFR 50.27Rate 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
Study 21 CFR 312.56Rate 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
B. FalseExplanation
An *investigator shall provide the *sponsor....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
Study 21 CFR 312.53(1)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.
All of the above
- E.
A & C only
Correct Answer
E. A & C onlyExplanation
Study 21 CFR 312.110Rate 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
Study 21 CFR 56.105 (Waiver of IRB Requirement)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
Study 21 CFR 312.88Rate 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
Study 21CFR 312.84Rate 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
Within 5 WORKING days; Study 21 CFR 56.104(c)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
to the Sponsor, not investigator. Study 21 CFR 312.42Rate 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
Allows for emergency use. Study 21 CFR 312.36Rate this question:
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