SOCRA Basic 1

Question 1

What is 21CFR50 Subpart D?

Accepted Answer

Additional Safeguards for Children in Clinical Investigations

Answer

Records and Reports

Answer

Protection of Human Subjects

Answer

IRB Functions and Operations

Question 2

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?

Accepted Answer

CRO - Contracted Research Organization

Answer

CRO - Center for Research Operations

Answer

CRO - Clinical Research Organization

Answer

CRO - Contracted Research Operations

Question 3

What is 21CFR50.54 Subpart D?

Accepted Answer

Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

Answer

Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.

Answer

Requirements for permission by parents or guardians and for assent by children.

Answer

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.

Question 4

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

Accepted Answer

21CFR11

Answer

21CFR812

Answer

21CFR312

Answer

21CFR56

Question 5

What is 21CFR50.25 Subpart B?

Accepted Answer

Elements of Informed Consent

Answer

Documentation of Informed Consent

Answer

Exemptions of Informed Consent

Answer

Documentation of Emergency Use of Experimental Treatments

Question 6

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

Accepted Answer

21CFR312

Answer

45CFR46

Answer

21CFR11

Answer

21CFR812

Question 7

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

Accepted Answer

Good Clinical Practice (GCP)

Answer

The ICH

Answer

Fundamental Ethical Principles (FEP)

Answer

The Declaration of Helsinki

Question 8

What is the FDA form 3455?

Accepted Answer

Disclosure - Financial Interests and Agreements of Clinical Investigators

Answer

Certification - Financial Interests and Arrangements of Clinical Investigators

Answer

Declaration of Conflict of Interest

Answer

Certification - Disclosure of Conflict of Interest

Question 9

What does 21CFR54 deal with?

Accepted Answer

Financial disclosure of clinical investigators

Answer

IRB regulations

Answer

Exemptions of Informed Consent for emergency use

Answer

Protection of human subjects: prisoners

Question 10

What is 45CFR46?

Accepted Answer

HHS - Protection of Human Subjects

Answer

HHS - Protection of Research Participants

Answer

FDA - Protection of Research Participants

Answer

DDS - Protection of Human Subjects