Glossary
of Clinical Trial Terms
There are a lot of words about clinical research that may be new to you. This glossary provides definitions for terms you may want to know.
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A
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Abbreviated New Drug Application (ANDA)
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Acid Reflux
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Acute Coronary Syndrome (ACS)
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Acute Hepatic Failure
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Acute Myocardial Infarction
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Advanced Lung Squamous Cell Carcinoma (LUSC)
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Adverse event
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Adverse Event Grading
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Age-Related Macular Degeneration (AMD)
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Aging Hands
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Alopecia Areata
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Alzheimer’s Disease
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Angina Pectoris
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Anterior Segment
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Antibody-Drug Conjugates
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Anticoagulation
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Arm
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Arrhythmia
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Arterial Closure
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Astigmatism
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Atherosclerosis
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Atopic Dermatitis
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Atrial Arrhythmia
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Atrial Fibrillation (Afib)
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Autoimmune Digestive Disorders
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- B
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C
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Cancer Vaccines
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CAR T-Cell Therapy
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Cardiology
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Cardiomyopathy
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Case Report Form (CRF)
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Cataract
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Celiac Disease
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Cell and Gene Therapies
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Cell Therapy
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Central Nervous System (CNS)
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Central Retinal Vein Occlusion (CRVO)
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Centralized Monitoring
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Checkpoint Inhibitors
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Chronic Obstructive Pulmonary Disease (COPD)
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Cirrhosis
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Clear Cell Renal Cell Carcinoma (CCRCC)
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Clinical Research
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Clinical Research or Study Coordinator (CRC)
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Clinical Study Build
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Clinical Trial
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ClinOps (Clinical Operations)
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Colon cancer
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Companion Diagnostics CDx
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Concomitant Medication
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Conflict of Interest
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Congestive Heart Failure (CHF)
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Conjunctivitis
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Control Group
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Controlled Clinical Trial
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Corneal Abrasion/Ulcer
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Coronary Artery Disease (CAD)
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CRA (Clinical Research Associates)
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CRO (Contract Research Organization)
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Crohn’s Disease
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cSCC (Cutaneous Squamous Cell Carcinoma)
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ctDNA
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CTMS (Clinical Trial Management System)
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Cutaneous Lupus Erythematosus
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Cytokine Release Syndrome (CRS)
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- D
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E
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EASI Score
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eConsent
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Eczema
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EDC
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Edema
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Efficacy
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Electronic Clinical Outcome Assessment (eCOA)
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Electronic Source (eSource)
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Eligibility Criteria
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Endometriosis
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Endoscopic Retrograde Cholangiopancreatography (ERCP)
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Endpoint
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Enrollment
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Epilepsy
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Epileptologists
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ePRO (Electronic Patient-Reported Outcome)
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Erythema
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eTMF
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- F
- G
- H
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I
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Immuno-oncology
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Immunotherapy
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Inclusion/Exclusion criteria
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IND-Enabling Trial
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Inflammatory Bowel Disease (IBD)
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Inflammatory Myopathies
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Informed Consent
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Informed Consent Form
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Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
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Investigational New Drug Application
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Investigational New Drug Application (IND)
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Irritable Bowel Syndrome (IBS)
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IRT (Interactive Response technology)
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itRECIST
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- J
- K
- L
- M
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N
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Nerve Conduction Studies (NCS)
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Nerve Conduction Studies (NCS)
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Neurocritical Care
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Neurodevelopmental Disabilities
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Neurogastroenterology
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Neurology
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Neuromuscular Medicine
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Neuromuscular Transmission
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New Drug Application (NDA)
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NK cells
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Non-Alcoholic Steatohepatitis (NASH)
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Nonalcoholic fatty liver disease (NAFLD)
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- O
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P
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Parkinson’s Disease
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PASI Score
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PDUFA
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Pediatric Neurology
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Peripheral Nervous System (PNS)
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Pharmacokinetics
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Pharmacovigilance
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Phase I
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Phase II
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Phase III
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Phase IV
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PI (Principal Investigator or Primary Investigator)
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Placebo
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Placebo Controlled Study
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Polymyositis
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Pompe Disease
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Posterior Segment
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Postmenopausal Osteoporosis
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Postprandial Distress Syndrome (PDS)
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Presbyopia
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Protocol
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Protocol Amendments
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Protocol Deviations
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Prurigo Nodularis
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Pruritus
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Psoriasis
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- Q
- R
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S
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Safety Monitoring Plan
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SCC (Squamous Cell Carcinoma)
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Scleroderma
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SCORAD Assessment
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Screening Log
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Screening Process
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Sequencing
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Skin Cancer
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Source Data Verification (SDV)
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Source Document
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Spinal Cord Hemorrhage
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Spinal Cord Ischemia
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Standard Operating Procedure (SOPs)
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Stopping Rules
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Stratification
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Stroke
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Sub-I (The Sub-Investigator)
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Subcutaneous Fat
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Subjective Endpoints
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Swimmer’s Itch (Cercarial Dermatitis)
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Synthetic Control Arm
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