SOCRA Knowledge 1

Question 1

Which of the following is a disclosure of financial interests form?

Accepted Answer

FDA Form 3455

Answer

21 Cfr 312

Answer

3500, Fda 3500

Answer

Form 3454

Question 2

The form ___ is used for investigational new drugs (or IND)

Accepted Answer

1571

Answer

1572

Answer

3500a

Answer

1583

Question 3

Which of the following is 21 CFR 56.106 Subpart B?

Accepted Answer

Registration

Answer

Certification

Answer

Licensure

Answer

Fda Form 3455

Question 4

What is 21 CFR 50.27?

Accepted Answer

Documentation of informed consent

Answer

Exception from general requirements

Answer

Hhs - protection of human health subjects

Answer

Irb review of research

Question 5

_________ means the party who submits a marketing application to FDA for approval of a drug device or biologic product.

Accepted Answer

Clinical Investigator

Answer

Contract Research Organization

Answer

Authors Of Similar Models

Answer

The Sponsor

Question 6

The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization?

Accepted Answer

Sponsor

Answer

FDA

Answer

IRB

Answer

Coordinator

Question 7

What is the minimum number of IRB members?

Accepted Answer

5

Answer

3

Answer

6

Answer

10

Question 8

In a non-emergency situation, under which of the following conditions, if any, may subjects been rolled into a study prior to IRB/IEC approval?

Accepted Answer

At least one member's primary area of interest is in a nonscientific area

Answer

A majority of the members'primary area of interest is in a scientific area

Answer

At least one member holds a Ph.D. degree or equivalent

Answer

A majority of the members are from or have ties to the institution of record

Question 9

A purpose of monitoring clinical trials is to verify that:

Accepted Answer

The rights, safety, and well-being of human subjects are protected

Answer

Investigators receive adequate payment for their participation in the clinical trial

Answer

The investigator has received annual reports from the sponsor

Answer

The regulatory agency has received all case history information of subjects enrolled on the clinical trial

Question 10

Which of the following is the proper way to make a correction to a CRF?

Accepted Answer

Add the initials of the person making the change, the date of the change, and , if necessary, a brief explanation of the change

Answer

Completely blacken the incorrect entry and then enter the correct information

Answer

Back date the corrected entry with the date of the original entry

Answer

Initial using the initials of the sponsor's representative who reviewed the change