An investigation in human subjects intended to discover or verify the clinical, pharmcological, and or pharmacodynamic of an investigational product.
What is Clinical Trial / Study
100
A document that describes all parameters of a study including the objective, design, methodology, statistical considerations and organization.
What is a Protocol or study plan?
100
CRO
What is Clinical Research Organization
100
Defined as an individual initiated threat of harm to self, staff or others.
What is A Behavioral Emergency
100
This procedure is completed upon admission and discharge.
What is the subject search
200
Guidelines established in 1990 from 25 member states of European Union, FDA, Japan, Health canada
What are the ICH Guidelines?
200
The initial introduction of an investigational new drug into humans, typically closely monitored and may be conducted in patients or normal volunteer subjects.
What is Phase I
200
NIH
What is National Institutes of Health
200
The employee that is first to identify a medical / behavioral emergency
Who is the first responder
200
Direct visualization of the subject at least every 1 hour unless specified otherwise by PI
What are ROUNDS
300
An independent body constituted of of medical, scientific, and nonscientific members, whose responsibility it is to protect the rights and well being of human subjects.
What is Institutional Review Board /IRB
300
A study in which the subject, the investigator, or anyoneassessing the outcomeis unaware of the treatment assignment.
What is a Blinded Study
300
GLP
What is Good Laboratory Practice
300
Rescuer #2 is responsible for what function during 2 person BLS.
What is Maintain Airway and give breaths
300
This procedure is used during a fire drill to identify that a room is verified as being empty.
What is placing a pillow right outside the door.
400
a pharmaceutical form of an active ingrediant or placebo being tested or being used as a reference in a clinical trial
What is Investigational Product or Test Article in GLP
400
One in which subjects do not know whether they are receiving the active drug or a placebo.
What is a Single-Blind study
400
eCRF
What is Electronic Case Report Form
400
Dial this to page / announce emergency
What is *774 / *775
400
The process of drug absorbtion, distribution, metabolization and elimination is known as
What is Pharmacokinetics
500
The Raw Data for Clinical Trials, information reported such as symptoms, dosing, lab tests, vital signs
What are CRF (Case Report Forms)
500
The process used by investigators to find and enroll appropriate subjects into a clinical trial.
What is Recruitment
500
IEC
What is Independent Ethics Committee
500
Can be administerd 1mg every 3-5 minutes during code.
What is Epinephrine
500
Placed in the anterior axillary line (AAL) at the same horizontal plane as V4.