Session 3

Question 1

Electronic Records cannot be used in lieu of paper records

Answer 1

false

Question 2

Computer systems (including hardware & software), controls & attendant documentation maintained under the electronic signature provision are subject to whose inspection?

Answer 2

FDA

Question 3

Electronic signatures are currently accepted for any and all records whether originally submitted in paper form or electronic form.

Answer 3

false

criteria do not apply to paper records that are or have been transmitted by electronic means.

Question 4

How does the FDA use financial disclosure information from investigators?

Answer 4

It is used in conjunction with other information to assess the reliability of the data

Question 5

Proprietary interest refers to property or other financial interest in the product including a patent, trademark, copyright or licensing agreement?

Answer 5

true

Question 6

What are the areas in which clinical investigators must provide financial disclosure?

Answer 6

Compensation affected by the outcome of the study

Significant payment of other sorts

Significant equity interest in the sponsor

Proprietary interest in the tested product

Question 7

Who is responsible for ensuring that data submitted to an NDA is accurate and complete?

Answer 7

Sponsor

Question 8

What method should monitors use to ensure that information submitted to sponsors by investigators is accurate?

Answer 8

Comparison of individual subject records and other supporting documentation with the reports being submitted to the sponsor

Question 9

Which types of products does the FDA Guideline for the Monitoring of Clinical Investigations apply?

Answer 9

Drugs, biological products, and
devices

Question 10

Which is/are the recommended component(s) that should be included in a sponsor’s monitoring report following a visit with and investigator?

Answer 10

Visit date

Name and address of the investigator visited

Name of the visiting Monitor

Question 11

What is the recommended frequency for monitoring visits by sponsors of a clinical investigation?

Answer 11

Periodic visits

Question 12

What must a monitor evaluate with respect to an investigator’s facilities prior to and during an investigation?

Answer 12

The adequacy of the facilities as required by the particular study

Question 13

Potential sources of bias in relation to financial matters and clinical studies are:

Answer 13

Financial interest if the clinical investigator in the outcome of the study

Proprietary interest in the product (e.g. a patent, trademark, copyright, etc.).

Equity interest in the sponsor

Question 14

Significant interest in the sponsor of a covered study refers to any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices (i.e. interests in a no publicly traded corporation), that exceeds $50,000, during the time the investigator is carrying out the investigation and for one year following completion of the study.

Answer 14

True
(21.CFR.54.2)

Question 15

What term refers to property or other financial interest in the product including a patent, trademark, copyright or licensing agreement?

Answer 15

proprietary interest

Question 16

A subject in a trial develops a viral infection. He calls to report it to the investigator and is told to go to the ER as a precautionary measure. The subject is seen, prescribed supportive medications and released from the ER after 18 hours.

Answer 16

Viral infection should be reported as an adverse event.

(21 CFR 312.32)