The Basics
A living individual who an investigator is conducting research on
What is a Human Subject?
Responsible for the day-to-day activities of a HSR study
Who is the Study Coordinator?
The ethics group that has been formally designated to review and approve research involving human subjects.
What is the Institutional Review Board (IRB)?
Established in 1959, this region situated between NC State, Duke & UNC, houses more than 300 research-focused companies and 65,000 workers.
What is Research Triangle Park?
GCP
What is Good Clinical Practice?
Determines safety of a new drug and maximum safe dosing
What is a Phase I Clinical Trial?
Ultimately responsible for all aspects of the study
Who is the Principal Investigator?
The person who monitors the running of an industry sponsored clinical trial?
Who is a Clinical Research Associate (CRA)?
Her story shined light on the racial inequities in the US research and health-care systems and brought to attention the importance of informed consent, when her bio-specimens were given to researchers without her knowledge.
Who is Henrietta Lacks?
SAE
What is a Serious Adverse Event?
You can't perform study assessments on a patient without getting _______ first.
What is a Signed Informed Consent Form?
They're suppling the (investigational) drugs & the money
Who is a Pharmaceutical Sponsor?
The codification of general and permanent regulations in the US, divided into 50 titles
What is the Code of Federal Regulations?
The decision in the case of the US v Karl Brandt in 1947, lead to the creation of this ten-point ethical code delimiting permissible medical experimentation on human subjects.
What is the Nuremberg Code?
CAPA
When outside interests unduly influence professional judgment
What is a Conflict of Interest?
Where you can find who the PI has given the OK to in order to preform study specific tasks
What is the Delegation of Authority (DOA) log?
The agency behind enforcing 21CFR11
What is the Food and Drug Adminstration?
In 1964 the World Medical Association met in Finland, to draft this document, named after the city in which the meeting was held, that describes the ethical standards of human-subjects research.
What is the Declaration of Helsinki?
IND
What is an Investigational New Drug?
They don't know what they're getting, you don't know either!
What is a Double-Blinded trial?
Your go-to team for "navigating" research at UNC
Who are the (really cool & awesome) Clinical Research Navigation Hub (CRNH) team?
The Vice Chancellor of Research at UNC
Who is Penny Gordon-Larsen?
In 2022, this institution was ranked 1st in psychology, sociology and population study research.
What is UNC?
ALCOA
What is Attributable, Legible, Contemporaneous, Original and Accurate?