Research Terms
What does IRB stand for?
What is the Institutional Review Board
What description of steps to be taken in a study.
What is a Protocol
The primary federal agency for conducting and supporting medical research?
Who is the NIH
One of the most important components of making a sound decision is having enough…
What is Information
This individual has overall responsibility for the conduct, oversight, and integrity of the clinical trial at the site.
Who is the Principal Investigator (PI)
What's does CRF stand for?
What is the Code of Federal Regulations
A statement which gives information about the study, its procedures, benefits, and risks to a prospective subjects so they can make an informed decision about participation.
What is a Consent form
The federal agency responsible for enforcing drug and food laws passed by Congress regarding the research, manufacture, and safety of drugs and foods
Who is the Food and Drug Administration (FDA)
When external interests improperly influence professional judgment in the conduct of a clinical trial?
What is Conflict of interest
This team member handles day-to-day study operations such as scheduling visits, collecting data, and maintaining source documentation.
Who is the Clinical Research Coordinator (CRC)
If participants are unaware of whether they are in experimental or control arms, then the study is_______?
What is a Blinded study
Who is classified as a vulnerable population in research or clinical studies ( 3 Main Population)
Who is Children/minors, Pregnant women, and Prisoners
The office within the Department of Health and Human Services responsible for developing, monitoring, and overseeing protection of human research subjects
Who is the Office of Human Research Protection (OHRP)
This principle addresses the fair distribution of the burdens and benefits of research.
What is Justice
This person represents the study sponsor and ensures that the site follows the protocol, GCP, and regulatory requirements.
Who is the Clinical Research Associate (CRA) / Monitor
An inactive pill, powder, or liquid that has no treatment value
What is a Placebo
According to the Belmont Report, what key ethical principles must be followed in research involving human subjects?
What is
1) Respect for Person
2) Beneficence
3) Justice
The U.S. government agency responsible for protecting the health of all Americans
What is the Department of Health and Human Services
These guidelines provides ethical standards, and promote consistent trial practices across the globe.
What is the ICH-GCP Guidelines
This role involves preparing regulatory submissions such as IND safety reports, protocol amendments, and IRB documentation.
Who is the Regulatory Specialist / Regulatory Coordinator?
Method based on chance by which a participant is selected for one arm of the study or another
What is Randomization
Which two major historical clinical trials have had a significant impact on shaping modern research practices?
What is WWII experiments / Nuremberg Trials and the Tuskegee Syphilis Study.
Together, they profoundly influenced ethical regulations like the Belmont Report and the establishment of IRBs.
The group responsible for funding a clinical trial ( provide one)
Who is the Sponsor (NIH, private foundations, pharmaceutical companies, etc.)
When children have the ability to understand the study, this additional agreement must be obtained.
What is Assent
This committee may be required for high-risk trials and is responsible for periodic review of safety data to recommend continuation, modification, or termination of a study.
What is the Data Safety Monitoring Board (DSMB)