This quiz assesses knowledge of SOCRA guidelines, focusing on ethical principles, regulatory compliance, and standards in clinical trials. It prepares learners for effective participation and oversight in human subjects research.
True
False
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True
False
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Autonomy of Patients
Respect for Persons
Informed Consent for Participation in Research
Beneficence
Justice
Fair Distribution of Cost/Benefit Ratio
Non-Exploitative and Well-Considered procedures
Maximizing Benefits, Minimizing Risks
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True
False
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The Principle Investigator
The Institutional Review Board
The Sponsor
The CRO
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21CFR11
21CFR812
21CFR312
21CFR56
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21CFR11
45CFR46
21CFR812
21CFR312
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The Bellmont Report
The National Research Act
The International Research Act
The Declaration of Helsinki
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21CFR11
21CFR812
45CFR46
21CFR312
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Notice of Inspection
Findings of Inspection
Declaration of Financial Interests and Arrangements
Certification of Financial Interests and Arrangments
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HHS - Protection of Human Subjects
DDS - Protection of Human Subjects
FDA - Protection of Research Participants
HHS - Protection of Research Participants
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1572
1571
3454
483
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True
False
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Certification - Disclosure of Conflict of Interest
Declaration of Conflict of Interest
Certification - Financial Interests and Arrangements of Clinical Investigators
Disclosure - Financial Interests and Agreements of Clinical Investigators
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Records and Reports
Protection of Human Subjects
IRB Functions and Operations
Additional Safeguards for Children in Clinical Investigations
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45CFR46
21CFR312
21CFR56
21CFR50
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True
False
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The ICH
Good Clinical Practice (GCP)
The Declaration of Helsinki
Fundamental Ethical Principles (FEP)
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Additional Safeguards and Protection
Additional Protection for Prisoners and Vulnerable Subjects
Additional Protection for Children and Unborn Fetuses
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
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Requirements for permission by parents or guardians and for assent by children.
Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
Wards.
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Federal Department of Food and Drug Administration
Canada Health
Health Canada
Federal Department of Canadian Health and Safety
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True
False
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CRO - Clinical Research Organization
CRO - Contracted Research Organization
CRO - Center for Research Operations
CRO - Contracted Research Operations
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Certification - Disclosure of Conflict of Interest
Declaration of Conflict of Interest
Certification - Financial Interests and Arrangements of Clinical Investigators
Declaration - Financial Interests and Arrangements of Clinical Investigators
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IRB regulations
Exemptions of Informed Consent for emergency use
Financial disclosure of clinical investigators
Protection of human subjects: prisoners
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Is intended as an implant and presents a potential for serious risk to health, safety, or the well-fare of the subject.
Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to health, safety, or the well-fare of the subject.
For use of the substantial importance of diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents potential risk to health, safety, or well-fare of the subject.
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21CFR56.108 Subpart D
21CFR56.108 Subpart C
21CFR56.106 Subpart B
I seriously can't believe this is a question
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Clinical Investigations not involving greater than minimal risk - children
Clinical Investigations involving greater than minimal risk - children
Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition - children
Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children
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Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children
Clinical Investigations not involving greater than minimal risk - children
Clinical Investigations involving greater than minimal risk - children
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HHS Definitions of Human Subject Protection
Basic HHS policy for Protection of Human Research Subjects
HHS Definitions for Protection of Human Research Subjects
HHS Policy for Human Subjects Protection
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Exception from General Requirements
General Requirements for Informed Consent
Exception from Informed Consent Requirements for Emergency Research
Documentation of Informed Consent
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Elements of Informed Consent
Documentation of Informed Consent
Exemptions of Informed Consent
Documentation of Emergency Use of Experimental Treatments
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Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
Requirements for permission by parents or guardians and for assent by children.
Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
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IRB Documentation
IRB Exemptions
IRB Duties
IRB Membership Guidelines
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True
False
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Documentation of Informed Consent
Exception from General Requirements
General Requirements for Informed Consent
Exception from Informed Consent Requirements for Emergency Research
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IRB review of research
IRB functions and operations
Expedited review procedures for certain kinds of research involving no more than minimal risk for minor changes in approved research
IRB registration
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True
False
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Additional Protection for Children and Unborn Fetuses
Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Additional Protection for Prisoners and Vulnerable Subjects
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
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Protection of Human Subjects
Additional Safeguards for Children in Clinical Investigations
IRB Functions and Operations
Records and Reports
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