SOCRA Certification BEST STUDY
GUIDE RATED A+
Investigator should (qualifications/agreements) - correct answer
by training/education and expertise
✅Be qualified
Be familiar with the product investigational
Be aware and comply with GCP and regulatory requirements
Permit auditing/monitoring
Delegate authority and maintain a log
Be responsible for the training of the staff
Nuremberg Code - correct answer ✅(1947) Ten guidelines for the ethical
treatment of human subjects in research - Came about after Nuremberg trial in
Germany during world war II
Legal force of the document was NOT established or incorporated directly into the
American or German law
Nuremberg Code 10 Ethical Guidelines - correct answer
of the human subject is absolutely essential.
✅ 1. Voluntary consent
2. The experiment should be such as to productive results for the good of society
unprocuable by other methods or means and not ransom and unnecessary in
nature.
3. The experiment should be so designed and based on the results of animal
experimentation and a knowledge of the natural history of the disease.
4. The experiment should be so conducted as to avoid all unnecessary physical
and mental suffering and injury.
5. No experiment should be conducted where there is an a prior reason to believe
that death or disabling injury will occur.
,SOCRA Certification BEST STUDY
GUIDE RATED A+
6. The degree of risk to be taken should never exceed that determined by the
humanitarian importance of the
problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect
the experimental subject against even remote possibilities of injury, disability, or
death.
8. The experiment should be conducted only by scientifically qualified persons.
The highest degree of skill and care.
9. During the course of the experiment the human subject should be at liberty to
bring the experiment to an end.
10. During the course of the experiment the scientist in charge must be prepared
to terminate the experiment at any stage.
Nuremberg Code - Key Principles - correct answer ✅ 1. Voluntary participation
2. Informed Consent
3. Minimization of risk
correct answer ✅
The Nuremberg Code and the Declaration of Helsinki are the basis for the... -
Code of Federal Regulations Title 45 Volume 46 which are
regulations issued by the United states department of heath and human services
Declaration of Helsinki - correct answer✅(1964) Is a set of ethical principles
regarding human experimentation developed for the medical community by the
WMA (World Medical Association).
Declaration is addressed primarily to physicians.
,SOCRA Certification BEST STUDY
GUIDE RATED A+
The WMA (World Medical Association) encourages others who are involved in
medical research involving human subjects to adopt these principles. Not legally
mandated
Declaration of Helsinki Key Principles - correct answer
takes precedence
✅1. Well-being of subjects
2. Respect for persons
3. Protection of subjects heath and rights
5. Special protection for vulnerable populations
Declaration of Helsinki has undergone.. - correct answer
clarifications - first in Finland in June 1964
✅ 7 revisions and 2
Who developed the Declaration of Helsinki and why - correct answer ✅
The
World Medical Associated (WMA) - as a statement of ethical principals for medical
research involving human subjects, including research on identifiable human
material and data
General Principals of the Declaration of Helsinki - correct answer
of my patient will be my first consideration"
✅1. "the health
2. It is the duty of the clinician to promote and safeguard the health, well-being
and rights of patients
3. Medical progress is based on research that ultimately must include studies
involving human subjects
4. The primary purpose of medical research involving human subjects is to
understand the causes, development and effects of diseases
, SOCRA Certification BEST STUDY
GUIDE RATED A+
5. Medical research is subject to ethical standards that promote and ensure
respect for all human subjects and protect their heath and rights
6. While the primary purpose of medical research is to generate new knowledge,
this goal can never take precedence over the rights and interests of individual
research subjects
7. It is the duty of clinicians who are involved in medical research to protect the
life, health, dignity, integrity, right to self-determination, privacy, and
confidentiality of personal information of research subjects
8. Physicians must consider the ethical, legal and regulatory norms and standards
for research involving human subjects in their own countries as well as applicable
international norms and standards
9. Medical research must be conducted in a manner that minimizes possible harm
to the environment
10. Medical research involving human subjects must be conducted only by
individuals with the appropriate ethics and and scientific education, training and
qualifications
11. Groups that are underrepresented in medical research should be provided
appropriate access to participation in research
12. Physicians who combine medical research with medical care should involve
their patients in research only to the extent that is justified by its potential
preventative, diagnostic or therapeutic value
13. Appropriate compensation and treatment for subjects who are harmed as a
result of participating in resear
The Belmont Report - correct answer ✅ April 18th, 1979
1. Respect for persons-informed consent, protection of vulnerable populations
2. Beneficence-non malfeasance
GUIDE RATED A+
Investigator should (qualifications/agreements) - correct answer
by training/education and expertise
✅Be qualified
Be familiar with the product investigational
Be aware and comply with GCP and regulatory requirements
Permit auditing/monitoring
Delegate authority and maintain a log
Be responsible for the training of the staff
Nuremberg Code - correct answer ✅(1947) Ten guidelines for the ethical
treatment of human subjects in research - Came about after Nuremberg trial in
Germany during world war II
Legal force of the document was NOT established or incorporated directly into the
American or German law
Nuremberg Code 10 Ethical Guidelines - correct answer
of the human subject is absolutely essential.
✅ 1. Voluntary consent
2. The experiment should be such as to productive results for the good of society
unprocuable by other methods or means and not ransom and unnecessary in
nature.
3. The experiment should be so designed and based on the results of animal
experimentation and a knowledge of the natural history of the disease.
4. The experiment should be so conducted as to avoid all unnecessary physical
and mental suffering and injury.
5. No experiment should be conducted where there is an a prior reason to believe
that death or disabling injury will occur.
,SOCRA Certification BEST STUDY
GUIDE RATED A+
6. The degree of risk to be taken should never exceed that determined by the
humanitarian importance of the
problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect
the experimental subject against even remote possibilities of injury, disability, or
death.
8. The experiment should be conducted only by scientifically qualified persons.
The highest degree of skill and care.
9. During the course of the experiment the human subject should be at liberty to
bring the experiment to an end.
10. During the course of the experiment the scientist in charge must be prepared
to terminate the experiment at any stage.
Nuremberg Code - Key Principles - correct answer ✅ 1. Voluntary participation
2. Informed Consent
3. Minimization of risk
correct answer ✅
The Nuremberg Code and the Declaration of Helsinki are the basis for the... -
Code of Federal Regulations Title 45 Volume 46 which are
regulations issued by the United states department of heath and human services
Declaration of Helsinki - correct answer✅(1964) Is a set of ethical principles
regarding human experimentation developed for the medical community by the
WMA (World Medical Association).
Declaration is addressed primarily to physicians.
,SOCRA Certification BEST STUDY
GUIDE RATED A+
The WMA (World Medical Association) encourages others who are involved in
medical research involving human subjects to adopt these principles. Not legally
mandated
Declaration of Helsinki Key Principles - correct answer
takes precedence
✅1. Well-being of subjects
2. Respect for persons
3. Protection of subjects heath and rights
5. Special protection for vulnerable populations
Declaration of Helsinki has undergone.. - correct answer
clarifications - first in Finland in June 1964
✅ 7 revisions and 2
Who developed the Declaration of Helsinki and why - correct answer ✅
The
World Medical Associated (WMA) - as a statement of ethical principals for medical
research involving human subjects, including research on identifiable human
material and data
General Principals of the Declaration of Helsinki - correct answer
of my patient will be my first consideration"
✅1. "the health
2. It is the duty of the clinician to promote and safeguard the health, well-being
and rights of patients
3. Medical progress is based on research that ultimately must include studies
involving human subjects
4. The primary purpose of medical research involving human subjects is to
understand the causes, development and effects of diseases
, SOCRA Certification BEST STUDY
GUIDE RATED A+
5. Medical research is subject to ethical standards that promote and ensure
respect for all human subjects and protect their heath and rights
6. While the primary purpose of medical research is to generate new knowledge,
this goal can never take precedence over the rights and interests of individual
research subjects
7. It is the duty of clinicians who are involved in medical research to protect the
life, health, dignity, integrity, right to self-determination, privacy, and
confidentiality of personal information of research subjects
8. Physicians must consider the ethical, legal and regulatory norms and standards
for research involving human subjects in their own countries as well as applicable
international norms and standards
9. Medical research must be conducted in a manner that minimizes possible harm
to the environment
10. Medical research involving human subjects must be conducted only by
individuals with the appropriate ethics and and scientific education, training and
qualifications
11. Groups that are underrepresented in medical research should be provided
appropriate access to participation in research
12. Physicians who combine medical research with medical care should involve
their patients in research only to the extent that is justified by its potential
preventative, diagnostic or therapeutic value
13. Appropriate compensation and treatment for subjects who are harmed as a
result of participating in resear
The Belmont Report - correct answer ✅ April 18th, 1979
1. Respect for persons-informed consent, protection of vulnerable populations
2. Beneficence-non malfeasance
