Clinical Trials Basics
What is the primary focus of a Phase I trial?
Safety, dosing, and side effects.
Who is responsible for conducting the trial at a site?
The Principal Investigator (PI)
What does AE stand for in clinical research?
Adverse event
What does CRF stand for?
Which month is Breast Cancer Awareness month?
October
Which phase primarily tests a drug's efficacy in a large population?
Phase III
Which team member handles patient scheduling?
Clinical Research Coordinator (CRC)
Which term best describes an event that causes death or serious harm?
Serious Adverse Event (SAE)
Informed Consent Form (ICF)
Which document describes the study's purpose, methodology, and design?
The protocol
Clinical Research Associate (CRA)
A serious, unexpected reaction related to the study drug.
Which regulatory agency oversees clinical trials in the U.S.?
The FDA (Food and Drug Administration)
The first FDA-approved cancer drug was derived from which plant?
The periwinkle plant
What is the process of randomly assigning participants to study groups called?
Randomization
Which group reviews protocols to protect participants' safety?
Institutional Review Board (IRB)
Which form is used to report SAEs to the FDA?
What is a Trial Master File (TMF)
A collection of essential study documents
What color ribbon represents Leukemia Awareness?
Orange
What is a double-blind study?
A study where neither the participants nor the investigators know which treatment is given.
Who provides financial support and oversight for a clinical trial?
The sponsor
Who is responsible for ensuring safety data is reviewed and reported accurately?
The Principal Investigator and Sponsor
Which form must investigators sign to participate in an FDA-regulated trial?
FDA Form 1572
The first chemotherapy agent came from studying which chemical weapon?
Mustard gas