FREE SOCRA Basic Questions and Answers

What is 21CFR50 Subpart D?

Records and Reports

Protection of Human Subjects

IRB Functions and Operations

Additional Safeguards for Children in Clinical Investigations

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What is a person or an organization (commercial, academic, or other) contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function?

CRO - Center for Research Operations

CRO - Clinical Research Organization

CRO - Contracted Research Organization

CRO - Contracted Research Operations

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What is 21CFR50.54 Subpart D?

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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The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is..

21CFR11

21CFR812

21CFR312

21CFR56

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What is 21CFR50.25 Subpart B?

Elements of Informed Consent

Documentation of Informed Consent

Exemptions of Informed Consent

Documentation of Emergency Use of Experimental Treatments

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The Code of Federal Regulations that applies to Investigational New Drug Applications is..

21CFR312

45CFR46

21CFR11

21CFR812

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The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as...

The ICH

Fundamental Ethical Principles (FEP)

The Declaration of Helsinki

Good Clinical Practice (GCP)

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What is the FDA form 3455?

Disclosure - Financial Interests and Agreements of Clinical Investigators

Certification - Financial Interests and Arrangements of Clinical Investigators

Declaration of Conflict of Interest

Certification - Disclosure of Conflict of Interest

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What does 21CFR54 deal with?

IRB regulations

Exemptions of Informed Consent for emergency use

Financial disclosure of clinical investigators

Protection of human subjects: prisoners

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What is 45CFR46?

HHS - Protection of Research Participants

FDA - Protection of Research Participants

DDS - Protection of Human Subjects

HHS - Protection of Human Subjects

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The World Medical Association (WMA) ethical principals for medical research involving human subjects is called....

The National Research Act

The Bellmont Report

The Declaration of Helsinki

The International Research Act

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FREE SOCRA Basic Questions and Answers

What is 21CFR50 Subpart D?

What is a person or an organization (commercial, academic, or other) contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function?

What is 21CFR50.54 Subpart D?

The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is..

What is 21CFR50.25 Subpart B?

The Code of Federal Regulations that applies to Investigational New Drug Applications is..

The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as...

What is the FDA form 3455?

What does 21CFR54 deal with?

What is 45CFR46?

The World Medical Association (WMA) ethical principals for medical research involving human subjects is called....

FREE SOCRA Knowledge Questions and Answers

Ace Your Certification: SOCRA Practice Test Prep

What is 21CFR50 Subpart D?

What is a person or an organization (commercial, academic, or other) contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function?

What is 21CFR50.54 Subpart D?

The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is..

What is 21CFR50.25 Subpart B?

The Code of Federal Regulations that applies to Investigational New Drug Applications is..

The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as...

What is the FDA form 3455?

What does 21CFR54 deal with?

What is 45CFR46?

The World Medical Association (WMA) ethical principals for medical research involving human subjects is called....

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