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Clinical Glossary

Adverse Drug Reaction (ADR) ( See Definition )
Adverse Event (AE) ( See Definition )
Adverse Event Reports ( See Definition )
Assurance ( See Definition )
Biologic ( See Definition )
Biotechnology ( See Definition )
Blinding ( See Definition )
Case Report Form (CRF) ( See Definition )
Certified Research Coordinator (CCRC) ( See Definition )
Clinical Investigation ( See Definition )
Clinical Research ( See Definition )
Clinical Research Associate (CRA) ( See Definition )
Clinical Research Coordinator (CRC) ( See Definition )
Clinical Study Materials ( See Definition )
Clinical Trial ( See Definition )
Common Rule ( See Definition )
Consent Form ( See Definition )
Contract Research Organization (CRO) ( See Definition )
Control Group ( See Definition )
Data ( See Definition )
Data Management ( See Definition )
Deception ( See Definition )
Declaration of Helsinki ( See Definition )
Demographic Data ( See Definition )
Device ( See Definition )
Documentation ( See Definition )
Double-Blind ( See Definition )
Drug ( See Definition )
Drug or Device Accountability Records (DAR) ( See Definition )
Drug Product ( See Definition )
Effective Dose ( See Definition )
Efficacy ( See Definition )
Ethics Committee ( See Definition )
Exclusion Criteria ( See Definition )
Family Educational Rights and Privacy Act (FERPA) ( See Definition )
FDA Form 1572 ( See Definition )
Food and Drug Administration (FDA) ( See Definition )
Food Drug and Cosmetic Act (FD & C Act ) ( See Definition )
Formulation ( See Definition )
Generic Drug ( See Definition )
Good Clinical Practice (GCP) ( See Definition )
Human Subject ( See Definition )
In Vitro Testing ( See Definition )
In Vivo Testing ( See Definition )
Inclusion Criteria ( See Definition )
Informed Consent ( See Definition )
Institution ( See Definition )
Institutional Review Board (IRB) ( See Definition )
Investigational Device Exemption (IDE) ( See Definition )
Investigational New Drug Application (IND) ( See Definition )
Investigator ( See Definition )
Investigator?s Brochure ( See Definition )
Longitudinal Study ( See Definition )
MedWatch Program ( See Definition )
Monitor ( See Definition )
Monitoring ( See Definition )
Multiple Project Assurance ( See Definition )
National Institutes of Health (NIH) ( See Definition )
National Research Act ( See Definition )
New Drug Application (NDA) ( See Definition )
Nuremberg Code ( See Definition )
Off Label ( See Definition )
Office for Human Research Protection (OHRP) ( See Definition )
Open-Label Study ( See Definition )
Orphan Drug ( See Definition )
Over-the-Counter (OTC) ( See Definition )
Patient ( See Definition )
Pharmacoeconomics ( See Definition )
Phase I Study ( See Definition )
Phase II Study ( See Definition )
Phase III Study ( See Definition )
Phase IV Study ( See Definition )
Pivotal Study ( See Definition )
Placebo ( See Definition )
Pre-Clinical Testing ( See Definition )
Protection of Pupil Rights Amendment (PPRA) ( See Definition )
Protocol ( See Definition )
Protocol Amendment ( See Definition )
Quality Assurance ( See Definition )
Randomization ( See Definition )
Recruitment ( See Definition )
Recruitment Period ( See Definition )
Regulatory Affairs ( See Definition )
Research ( See Definition )
Research Team ( See Definition )
Risk-Benefit Ratio ( See Definition )
Safety Reports ( See Definition )
Serious Adverse Event (SAE) ( See Definition )
Single Project Assurance ( See Definition )
Source Data ( See Definition )
Source Documentation ( See Definition )
Sponsor ( See Definition )
Standard Operating Procedure (SOP) ( See Definition )
Standard Treatment ( See Definition )
Sub-investigator ( See Definition )
Subject/Study Subject ( See Definition )
Telephone Report ( See Definition )
Treatment IND ( See Definition )
Unexpected Adverse Drug Reaction ( See Definition )
Vulnerable Subjects ( See Definition )
Well-being ( See Definition )