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