Module 3 Key Roles

Question 1

Which of the following is an example of how the principle of “Justice” can be applied to a study with human subjects?

Answer 1

Ensuring that the selection of subjects includes people from all segments of the population

Question 2

What is the status of ICH in the United States?

Answer 2

It is a guideline

Question 3

The ICH GCP Guidelines set standards for the ___ , ___, ___, and ___ of clinical research.

Answer 3

for the design, conduct, monitoring, and reporting.

Question 4

Sponsors may transfer any or all of their responsibilities to a contract research organization (CRO) under which of the following conditions:

Answer 4

1. The transferred responsibilities are described in writing
2. The CRO complies with regulations and held to the same standards for non-compliance

Question 5

The sponsor of a pharmaceutical investigation obtains a signed ______ which includes CV, statement of Investigator’s experience, explanation of termination circumstances, and statement of investigator commitment.

Answer 5

Statement of Investigator FDA Form 1572

Question 6

The purpose of trial monitoring is to verify 1.__ 2.___ 3.___

Answer 6

1. the rights & well-being of subjects are protected
2. the reported trial data are complete and verifiable from documents.
3. the conduct of the trial is in compliance with approved protocol, GCP, and regulations.

Question 7

By signing Form FDA 1572 or the investigator agreement, the investigator agrees to: (5)

Answer 7

1. conduct the study in accordance with the current protocol
2. not make changes to the research without sponsor & IRB approval, except for immediate hazards
3. obtain IRB approval prior to starting
4. ensure IRB complies with 21 CFR 56 for initial & continuing review
5. Conduct/supervise the investigation personally.

Question 8

T/F It is the sponsor’s responsibility to ensure all persons assisting with the trial are adequately informed.

Answer 8

False. It is the investigators responsibility.

Question 9

T/F only the principal investigator is allowed to transcribe data from the source document to CRF.

Answer 9

False.

Question 10

A subject in an industry-sponsored clinical research trial experiences a serious, unanticipated adverse event that appears to be related to the study drug. How should the PI proceed after the discovery of the adverse event occurrence? Report the adverse drug experience ___

Answer 10

immediately to the monitoring entity and the local IRB

Question 11

Who is responsible for quality control for data handling?

Answer 11

The sponsor

Question 12

T/F According to FDA guidelines, the financial disclosure form should be completed by all study personnel that have significant role in the study

Answer 12

True

Question 13

T/F For an industry sponsored trial, a site should allow only the sponsor’s monitor access to the regulatory files

Answer 13

False