FREE SOCRA Knowledge Questions and Answers

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

21 Cfr 312

3500, Fda 3500

Form 3454

FDA Form 3455

Correct! Wrong!

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

1571

1572

3500a

1583

Correct! Wrong!

Which of the following is 21 CFR 56.106 Subpart B?

Certification

Licensure

Fda Form 3455

Registration

Correct! Wrong!

What is 21 CFR 50.27?

Exception from general requirements

Documentation of informed consent

Hhs - protection of human health subjects

Irb review of research

Correct! Wrong!

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

Contract Research Organization

Authors Of Similar Models

The Sponsor

Clinical Investigator

Correct! Wrong!

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

FDA

IRB

Sponsor

Coordinator

Correct! Wrong!

What is the minimum number of IRB members?

Correct! Wrong!

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?

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

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

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

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

Correct! Wrong!

A purpose of monitoring clinical trials is to verify that:

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

Investigators receive adequate payment for their participation in the clinical trial

The investigator has received annual reports from the sponsor

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

Correct! Wrong!

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

Completely blacken the incorrect entry and then enter the correct information

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

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

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

Correct! Wrong!

The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _______ following the study's completion.

6 months

1 year

2 years

5 years

Correct! Wrong!

FREE SOCRA Knowledge Questions and Answers

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

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

Which of the following is 21 CFR 56.106 Subpart B?

What is 21 CFR 50.27?

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

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

What is the minimum number of IRB members?

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?

A purpose of monitoring clinical trials is to verify that:

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

The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _______ following the study's completion.

FREE SOCRA Basic Questions and Answers

Ace Your Certification: SOCRA Practice Test Prep

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

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

Which of the following is 21 CFR 56.106 Subpart B?

What is 21 CFR 50.27?

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

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

What is the minimum number of IRB members?

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?

A purpose of monitoring clinical trials is to verify that:

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

The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _______ following the study's completion.

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