Deck 10: Clinical Investigations

Question 1

The overall goal of clinical research is to maintain the safety of the research participants while determining the efficacy of the investigational product.

Answer 1

True

Question 2

Co-investigators retain the sole responsibility for the entire research study.

Answer 2

False

Question 3

The PI overseas any adverse events in the study and answering violations that occur during the course of the study.

Answer 3

True

Question 4

CH Guidelines and FDA support the practice of "prequalifying" patients for a research study.

Question 5

The number of and severity of adverse events (AEs) will often determine whether an investigational drug or device application will be submitted for FDA approval.

Question 6

During Phase IV of clinical studies, the new drug or device is available to the public.

Question 7

In clinical research, the purpose is to translate laboratory research into applied clinical interventions.

Question 8

Verbal consents between participants and the researcher are allowed in clinical research studies.

Question 9

To be eligible to participate in a research study, a patient must meet all of the inclusion criteria and have a minimum of factors from the exclusion criteria.

Question 10

Research participants must be protected and well-informed of their study status at all times during a clinical study.

Question 11

All clinical research studies will use a randomization phase.

Question 12

The follow-up visit is significant because any trends or discrepancies in the participant's lab results can be detected and the PI will be made aware of the issue.

Question 13

Participants are typically randomized to their study group before they are screened for eligibility.

Question 14

Once the study medication or device is approved, the FDA does not require continued data collection.

Question 15

The term adverse events and significant adverse events are used interchangeably.

Question 16

When conducting clinical research, the two most critical aspects are:

A) to collect verbal consent and completion of the research study
B) to promote interdisciplinary collaboration among health professionals and publications of articles
C) the participants have a complete understanding of the study and to protect them at all times during the study
D) All of these

Question 17

Which is a role of the study coordinator?

A) recruiting subjects for the study
B) ensuring all of the research procedures were conducted
C) conducting on-site visits in the study
D) Monitoring the participant's safety and well-being during the study

Question 18

The clinical research associate is responsible for:

A) conducting on-site visits in the study
B) ensuring that the safety of participants and that they were treated with utmost care
C) reviewing participants' medical records and that data is being documented correctly
D) All of these
E) None of these

Question 19

Per ICH E6 Guidelines and FDA Code of Federal Regulations, the research site is responsible for:

A) providing a copy of the informed consent form to the participant
B) providing financial compensation to all participants
C) preventing participants from leaving the study early
D) All of these

Question 20

Which is an example of an SAE?

A) produces a birth defect
B) death of patient from clinical trial
C) requires extended hospitalization
D) All of these
E) None of these

Question 21

Which clinical trial phase is considered the "first-in-human" research study?

A) Phase I
B) Phase II
C) Phase III
D) Phase IV

Question 22

In which clinical trial phase, are participants randomized to evaluate the effectiveness and therapeutic range of a drug?

A) Phase I
B) Phase II
C) Phase III
D) Phase IV

Question 23

Which is an example of why a patient may exit early from a study?

A) Patient has experienced an AE or SAE
B) Patient moves out of town
C) Patient is unwilling to cooperate with the study procedure
D) All of these
E) None of these

Question 24

Which person oversees and manages adverse events that occur to study participants?

A) Principal Investigator
B) Study Coordinator
C) Clinical study monitor
D) Trained medical technician

Question 25

Which of the following is performed by the clinical research associate (CRA)?

A) Recruiting study participants
B) Dispensing, tracking, and sorting study medications
C) Submitting Institutional Review Board paperwork
D) Conduction of on-site audits of study records

Question 26

When should the research site report serious adverse events to the study sponsor or IRB?

A) Within an hour
B) Within 24 hours
C) Within a week
D) As indicated in the protocol

Question 27

Which phase of research established the toxicity of an investigational medication?

A) Phase I
B) Phase II
C) Phase III
D) Phase IV