Clinical Training Test

1.

What is a 510(k)?

Submission of a protocol for a medical device study.

Clearance of a Drug to be used in device/drug combo study.

Notifying the FDA of intent to market a medical device.

None of the above.

2.

What factors are determined during a preclinical toxicology study?

Maximum lethal dose

Pharmacodynamic responses

Target organs of toxicity are indentified

All of the above

None of the above

3.

What is the main purpose of an EDC System?

Drug management

Record patient information and documentation

Randomization

Clinical Trial Results

4.

When a drug arrives to a clinical site and it's not the correct temperature it should be stored at, the CRA must:

Dispose of the drug on site.

Send the drug back to the CMO for destruction.

Place the drug in a refrigerator to get it to the correct temp. before administering it.

Give the patient the treatment yet log it in the system that it was not the correct temperature.

5.

When filing an NDA, you must provide the FDA which of the following:

Proof of efficacy

The ingredients of the drug and how it is manufactured

Plans for distribution and labeling once approved

A&C

All of the Above

6.

In regards to the picture on the screen, the Secondary packaging is:

The silver pack containing the pills.

The capsules containing the drug.

The box that the silver pack will go in.

None of the above.

7.

A BLA (Biologics License Application) Must include all of the below EXCEPT:

Applicant information

Product/Manufacturing information

Pre-Clinical studies and Clinical Studies

All comparators on the market

Labeling

8.

During the drug development state, a New Chemical Entity is formed and that is what is administered to the animal.

True

False

9.

When planning a clinical study, the purpose of an IRB is:

Protect the rights and welfare of the participants in the study

Ensure the protocol follows all the rules the sponsor put in place

Review the inclusion/exclusion requirement to be sure that the appropriate participants arte identified for the study

A&C

B&C

10.

When it comes to data management, what does eCRF stand for?

Electronic Case Registration Form

Electronic Case Report Form

Electronic Clinical Report Function

Electronic Clinical Report Filed

11.

All Phase 1 studies test in healthy patients only.

True

False

12.

In regards to FDA submissions, what does ANDA stand for?

Abbreviated New Drug Association

Abbreviated New Drug Application

Adverse New Drug Administration

Associated New Drug Application

13.

When a person has a negative reaction to a drug, the official term used to describe that is:

Immune Response

Serious Adverse Event

Reaction Response

Serious Side Effect

14.

A FDA Warning Letter is officially called:

Form FDA 483

FDA 438

FDA Red Alert

None of the above

15.

What are the four trace elements that a drug is to be tested for before being released by CMO to sites?

Magnesium, Lead, Aluminum

Lead, Mercury, Tin, Carbon

Mercury, Tin, Lead, Iron

Mercury, Cadmium, Arsenic, Lead

16.

Receiving Orphan Designation Status:

Qualifies the sponsor for various incentives including tax credits for clinical testing.

Granted only for drugs/biologics that treat a rare disease or condition.

It is approved and granted by the IRB

A & B

All of the above

17.

An ANDA is different than regular NDA due to the fact:

You do not have to include preclinical and clinical data.

You must include all the chemical information regarding the drug.

You are required to include additional clinical studies results.

All of the above.

18.

What is a phase 2 study primarily looking to prove?

Safety

Toxicology

Efficacy and Correct Dosage

Comparison of Standard of Care

19.

Biologic drugs containing Monoclonal Antibodies are always large molecules.

True

False

20.

Bioavailability of a drug is:

How the biology of the drug is affected when it is administered.

How able the drug is to cure the disease.

The fraction of unchanged drug that reaches the circulatory system.

None of the above.

21.

When a drug/drug kit is damaged when being shipped to the site, the CRA takes that treatment out of the randomization in the system and destroys it on site.

True

False

22.

A company running a clinical study MUST choose their clinical sites before selecting a CRO to run the study.

True

False