Certified Clinical Research Professional Exam studying Questions and Answers Fully Solved
Latest Version 2025-2026
What is the Nuremberg Code? - Answers10 guidance points for conducting clinical research,
emphasizing voluntary informed consent, benefits to society, and avoiding harm or suffering to
subjects.
When was the Nuremberg Code written? - Answers1947
What are the 10 points of the Nuremberg code? - AnswersVoluntary informed consent
Results benefit good of society
Experiments based on animal models and prior knowledge
Conduct research without physical or mental suffering
Stop research if believed to cause death or disabling injury
Risks should never exceed benefits
Adequate facilities needed
Research should only be conducted by scientifically qualified persons
Subject can withdraw at any time
Scientist in charge must end research if they believe continuing will result in harm
When was the Belmont report published? - Answers1979
What are the three principles of the Belmont report? - AnswersRespect for persons, beneficence,
and justice
What does respect for persons mean from the Belmont report? - AnswersPeople are
autonomous agents, corresponds with informed consent
When was the Declaration of Helsinki published? - Answers1964
What is the Declaration of Helsinki? - AnswersDocument outlining Good Clinical Practice (GCP)
for physicians, focusing on research ethics, patient well-being, and the importance of research
ethics committees.
Who wrote the Declaration of Helsinki? - AnswersWMA (World Medical Association)
21 US CFR Part 11 - AnswersRegulations for electronic records, electronic signatures, and
handwritten signatures in electronic records, ensuring accuracy, reliability, and protection
against invalid records.
, 21 US CFR Part 50 - AnswersRegulations protecting human subjects in FDA clinical
investigations and trials, aiming to safeguard subject rights and safety during research.
Clinical investigation - AnswersExperiments involving a test article and human subjects,
conducted by an investigator to assess the effects of the article.
Investigator - AnswersIndividual conducting a clinical investigation to evaluate the effects of a
test article on human subjects.
Sponsor - AnswersEntity initiating but not conducting a clinical trial, responsible for the trial's
management and funding.
IRB (Institutional Review Board) - AnswersFormal committee designated by an institution to
review biomedical research involving human subjects, ensuring ethical standards are met.
Assent - AnswersA child's affirmative agreement to participate in a clinical trial, distinct from
informed consent.
Test article - AnswersAny drug, medical device for human use, etc subject to regulation under
CFR Part 50
LAR (Legally Authorized Representative) - AnswersIndividual authorized by law to provide
consent on behalf of a prospective subject who cannot provide consent.
Ward - AnswersA child under legal custody of the state or another institution, requiring special
protections in research.
Minimal risk - AnswersRisk level in research where the risks to subjects are minimized and
reasonable in relation to anticipated benefits and knowledge gained.
Equitable selection of subjects - AnswersFair and unbiased selection of subjects in research
studies, ensuring diverse representation and avoiding discrimination.
Informed consent - AnswersProcess involving informing subjects about research, risks, benefits,
alternatives, confidentiality, and voluntariness, documented by signed consent forms.
What does 21 US CFR Part 56 govern? - AnswersEstablishes and regulates IRBs to protect
rights and welfare of human subjects in research
IRB Membership requirements - Answersat least 5 members, various backgrounds
One scientist member
One non-scientist member
One not affiliated with institution
No members can be involved in research being reviewed
Latest Version 2025-2026
What is the Nuremberg Code? - Answers10 guidance points for conducting clinical research,
emphasizing voluntary informed consent, benefits to society, and avoiding harm or suffering to
subjects.
When was the Nuremberg Code written? - Answers1947
What are the 10 points of the Nuremberg code? - AnswersVoluntary informed consent
Results benefit good of society
Experiments based on animal models and prior knowledge
Conduct research without physical or mental suffering
Stop research if believed to cause death or disabling injury
Risks should never exceed benefits
Adequate facilities needed
Research should only be conducted by scientifically qualified persons
Subject can withdraw at any time
Scientist in charge must end research if they believe continuing will result in harm
When was the Belmont report published? - Answers1979
What are the three principles of the Belmont report? - AnswersRespect for persons, beneficence,
and justice
What does respect for persons mean from the Belmont report? - AnswersPeople are
autonomous agents, corresponds with informed consent
When was the Declaration of Helsinki published? - Answers1964
What is the Declaration of Helsinki? - AnswersDocument outlining Good Clinical Practice (GCP)
for physicians, focusing on research ethics, patient well-being, and the importance of research
ethics committees.
Who wrote the Declaration of Helsinki? - AnswersWMA (World Medical Association)
21 US CFR Part 11 - AnswersRegulations for electronic records, electronic signatures, and
handwritten signatures in electronic records, ensuring accuracy, reliability, and protection
against invalid records.
, 21 US CFR Part 50 - AnswersRegulations protecting human subjects in FDA clinical
investigations and trials, aiming to safeguard subject rights and safety during research.
Clinical investigation - AnswersExperiments involving a test article and human subjects,
conducted by an investigator to assess the effects of the article.
Investigator - AnswersIndividual conducting a clinical investigation to evaluate the effects of a
test article on human subjects.
Sponsor - AnswersEntity initiating but not conducting a clinical trial, responsible for the trial's
management and funding.
IRB (Institutional Review Board) - AnswersFormal committee designated by an institution to
review biomedical research involving human subjects, ensuring ethical standards are met.
Assent - AnswersA child's affirmative agreement to participate in a clinical trial, distinct from
informed consent.
Test article - AnswersAny drug, medical device for human use, etc subject to regulation under
CFR Part 50
LAR (Legally Authorized Representative) - AnswersIndividual authorized by law to provide
consent on behalf of a prospective subject who cannot provide consent.
Ward - AnswersA child under legal custody of the state or another institution, requiring special
protections in research.
Minimal risk - AnswersRisk level in research where the risks to subjects are minimized and
reasonable in relation to anticipated benefits and knowledge gained.
Equitable selection of subjects - AnswersFair and unbiased selection of subjects in research
studies, ensuring diverse representation and avoiding discrimination.
Informed consent - AnswersProcess involving informing subjects about research, risks, benefits,
alternatives, confidentiality, and voluntariness, documented by signed consent forms.
What does 21 US CFR Part 56 govern? - AnswersEstablishes and regulates IRBs to protect
rights and welfare of human subjects in research
IRB Membership requirements - Answersat least 5 members, various backgrounds
One scientist member
One non-scientist member
One not affiliated with institution
No members can be involved in research being reviewed
