Informed Consent Form
ICF, the document used in the informed consent process
Source: ClinicalTrials.gov
Glossary of Terms
Healthy Control
In a clinical study, a person who does not have the disorder or disease being studied. Results from healthy...
Experimental Group
The group in a clinical research study that receives the drug, vaccine, or other intervention being tested. It is...
Experimental Drug
A substance that has been tested in the laboratory and has been approved by the US FDA for testing...
Experimental
In clinical trials, refers to a drug or procedure that has undergone basic laboratory testing and received approval from...
Expanded Access
A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access...
Endpoint
In clinical trials, an event or outcome that can be objectively measured to determine whether the intervention being studied...
Early Phase 1 (formerly listed as Phase 0)
A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or...
Double-Blind Study
A type of clinical trial in which neither the researcher doing the study nor the patients know the specific...
Cutaneous Lupus
Cutaneous lupus causes a rash or lesion on the skin, usually when exposed to sunlight. One of the common...
Consent Process
A process in which patients are given important information such as possible risks and benefits, about a medical procedure...
Cohort Study
A research study that compares a particular outcome in groups of individuals who are alike in many ways but...