Phase
The stage of a clinical trial studying a drug or biological product, based on definitions by the FDA. The...
Glossary of Terms
Outcome
A specific result or effect that can be measured.
Source: NCI
Open-Label Study
A type of study in which both the health providers and the patients are aware of the drug or...
Office for Human Research Protections (OHRP)
The Office within the U.S. Department of Health and Human Services that protects the rights, welfare, and well-being of...
Off-Label
Describes the legal use of a prescription drug to treat a disease or condition for which the drug has...
Masking
Investigator
Investigational New Drug
A substance that has been tested in the laboratory and has been approved by the U.S. FDA for testing...
Investigational Group
The group in a clinical research study that receives the drug, vaccine, or other intervention being tested. It is...
Investigational Drug
A substance that has been tested in the laboratory and has been approved by the US FDA for testing...
Intervention Group
The group in a clinical research study that receives the drug, vaccine, or other intervention being tested. It is...
Institutional Review Board (IRB)
A group of scientists, doctors, clergy, and patient advocates that reviews and approves the detailed plan for a clinical...