Week 1

Question 1

CRA

Answer 1

Clinical Research Associate
Auditors who visit and work with clinical trial sites on behalf of a CRO or sponsor
CRAs role is to ensure proper study protocol and conduct according to the CTP at the assigned site

Question 2

Sponsor

Answer 2

Company that owns the drug

Question 3

CRO

Answer 3

Contract Research Organizer

Third Party Monitoring company hired by Sponsor to monitor a Clinical Trial

Question 4

CTP

Answer 4

Clinical Trial Protocol

Document that contains the entire study procedures for a CRA to follow in order to ensure site compliance

Question 5

PI

Answer 5

Primary Investigator

An individual who actually conducts a clinical investigation.

Question 6

CRC

Answer 6

Clinical Research Coordinator
The organizer of the research lab. A person in this role works closely with the study’s PI and oversees the team of clinical research associates in order to ensure that the study runs in compliance with the CTP and Good Clinical Practices (GCPs)

Question 7

IRB

Answer 7

Institutional Review Board
Appointed group of individuals who chare expertise in a given indication designated to review and monitor biomedical research involving human subject.

Question 8

Pre Clinical Research

Answer 8

refers to studies that do not involve human subjects. The purpose is to provide information on safety and if possible, efficacy, in order to begin conducting clinical trials in humans. These studies help determine a starting dose

Question 9

Phase 0

Answer 9

(usually animal trials) How will the body respond to the drug or device? Are there any Adverse Events(AEs)

Question 10

Phase I

Answer 10

What is the best dosage of the drug to maximize effectiveness and minimize side effects? With additional dosage, are there any AEs?

Question 11

Phase II

Answer 11

If we increase the number of subjects, will the effectiveness of the drug and side effects change of be consistent? Any New AEs? (Placebo testing also introduced in Phase II)

Question 12

Phase III

Answer 12

If we separate the subjects into groups and now compare the new drug to the “standard of care” drug, how effective is the new drug in comparison? Any new AEs? (After Phase III, drug is eligible to undergo FDA approval process)

Question 13

Phase IV

Answer 13

If we test this drug in hundreds of thousands of people, what additional side effects and AEs can we find? What other drugs work well in combination with new drug?

Question 14

SAE

Answer 14

Severe Adverse Event
Death
Prolonged Hospitalization
Birth Defects
Disability

Question 15

Therapeutic Indication

Answer 15

A reference to the specific symptom, reason, or medical condition the study is being conducted for

Question 16

Therapeutic Area

Answer 16

The Umbrella Term
Cardiovascular
CNS
Immunology
Infectious Disease
Metabolic and Endocrine
Oncology
Ophthalmology
Rare Disease
Respiratory