Clinical Trials
Types of clinical research
What is epidemiology, behavioral, health services, and clinical trials
IRB stands for
What is the Institutional Review Board
Clinical trials study what
What are drugs/drug combinations, surgeries, medical devices, existing treatments, change behaviors, improve quality of life for acute or chronic illnesses
Phase 1 Trial
What is test a drug or treatment in a small group (20-80) people. Learn safety and identify side effects
National Clinical Trial Day
What is May 20th
Epidemiology Research
What is the understanding of a disease by studying patterns, causes, and effects of health and disease in specific groups
Main goal of IRB
What is ensuring that the risks are reduced and are outweighed by the potential benefits of a study
Clinical trials follow a plan
What is a protocol
Phase II trial
What is new drug or treatment that is given to larger group (100-300) to determine its effectiveness and safety
First Clinical Trial was led by
What is James Lind
Behavioral Research
What is the understanding of human behavior and how it relates to health and disease
4 levels of IRB review
What is exempt, expedited, full committee, and expedited/full committee
Protocol involved
What is goal of study, who is eligible to participate, protection against risks, details of study treatments, duration, and information gathered
Phase III trial
What is new drug or treatment given to large group of people (1000-3000) to confirm effectiveness, monitor side effects, and compares with similar treatments
First Clinical Trial was based on
What is scurvy
Health Service Research
What is the investigation of how people access health care providers and health care services
Where IRB application is sent for approval
What is Human Research Protection (HRP)
Sponsors of research include
What are institutions, companies, and government agencies
Randomization
What is the process by which treatments are assigned to participants by chance rather than choice
Scurvy
What is a disease caused by vitamin C deficiency
Clinical Trials Research
What is the evaluation of the effects if an intervention on health outcomes.
2018 Common Rule Changes
What is the definition of Human Subject Research, continuing review, exemptions, informed consent
Informed consent
What is the process of providing key information about research study before deciding to participate
Placebo
What is an inactive product that resembles the test product without its treatment value
Symptoms of scurvy
What is swollen and bleeding gums, and opening of previously healed wounds