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.

2
- 21 CFR Part 11
A
- Abbreviated New Drug Application (ANDA)
- Acid Reflux 
- Adverse event
- Adverse Event Grading
- Age-Related Macular Degeneration (AMD)
- Aging Hands
- Alopecia Areata
- Anterior Segment
- Arm
- Astigmatism
- Atopic Dermatitis
B
- Basal Cell Carcinoma
- Baseline
- Bias
- Biologic
- Biologic License Application
- BLA
C
- Case Report Form (CRF)
- Cataract
- Celiac Disease
- Centralized Monitoring
- Checkpoint Inhibitors
- Clear Cell Renal Cell Carcinoma (CCRCC)
- Clinical Research
- Clinical Research or Study Coordinator (CRC)
- Clinical Study Build
- Clinical Trial
- ClinOps (Clinical Operations)
- Colon cancer 
- Companion Diagnostics CDx
- Concomitant Medication
- Conflict of Interest
- Conjunctivitis
- Control Group
- Controlled Clinical Trial
- Corneal Abrasion/Ulcer
- CRA (Clinical Research Associates)
- CRO (Contract Research Organization)
- Crohn’s Disease
- cSCC (Cutaneous Squamous Cell Carcinoma)
- ctDNA
- CTMS (Clinical Trial Management System)
- Cutaneous Lupus Erythematosus
- Cytokine Release Syndrome (CRS)
D
- Dandruff
- Data and Safety Monitoring Board (DSMB)
- Data and Safety Monitoring Plan (DSMP)
- Data Management
- Data Management Plan (DMP)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
- Dislocated Intraocular Lens (IOL)
- Double Chin
- Double Negative Breast Cancer
- Dry Eye Syndrome
E
- EASI Score
- eConsent
- Eczema
- EDC
- Edema
- Efficacy
- Electronic Clinical Outcome Assessment (eCOA)
- Electronic Source (eSource)
- Eligibility Criteria
- Endometriosis
- Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Endpoint
- Enrollment
- Epilepsy
- Epileptologists
- ePRO (Electronic Patient-Reported Outcome)
- Erythema
- eTMF
F
- Fibrosis
- Fingernail Psoriasis
- Food and Drug Administration (FDA)
G
- Gastroenterology
- Gene therapy
- Genitourinary System
- Geriatric Neurology
- Glaucoma
- Good Clinical Practice (GCP)
- Good Laboratory Practices (GLP)
- Gynecology
H
- Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
- Healthy volunteers
- Hepatology
- Hidradenitis suppurativa
- Hives
- Human Subject
- Hyperopia
- Hyperpigmentation
- Hypoxia
I
- Inclusion/Exclusion criteria
- IND-Enabling Trial 
- Inflammatory Bowel Disease (IBD)
- Inflammatory Myopathies 
- Informed Consent
- Informed Consent Form
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
- Investigational New Drug Application
- Investigational New Drug Application (IND)
- Irritable Bowel Syndrome (IBS)
- IRT (Interactive Response technology)
- itRECIST
J
- JAK inhibitor
K
- Keloids
- Keratoconus
L
- Lactose Intolerance
- Liver cirrhosis 
- Lupus
- Lysosomal Storage Disorders
M
- Macula
- Masking/Blinding
- Maternal-Fetal Medicine
- Midface Volume Deficit
- Motility
- Mucopolysaccharidosis
- Multiple Sclerosis (MS)
- Myopia
N
- Nerve Conduction Studies (NCS)
- Nerve Conduction Studies (NCS)
- Neurocritical Care
- Neurodevelopmental Disabilities
- Neurogastroenterology
- Neurology
- Neuromuscular Medicine
- Neuromuscular Transmission
- New Drug Application (NDA)
- Non-Alcoholic Steatohepatitis (NASH)
- Nonalcoholic fatty liver disease (NAFLD) 
- Nonalcoholic Steatohepatitis (NASH) 
O
- Objective Endpoints
- Office for Human Research Protection (OHRP)
- Open-Label Trial
- Ophthalmology
- Optic Nerve
- Osteoarthritis
- Over-the-Counter (OTC) Applications
P
- Parkinson’s Disease
- PASI Score
- PDUFA
- Pediatric Neurology 
- Peripheral Nervous System (PNS)
- Pharmacokinetics
- Pharmacovigilance
- Phase I
- Phase II
- Phase III
- Phase IV
- PI (Principal Investigator or Primary Investigator)
- Placebo
- Placebo Controlled Study
- Polymyositis
- Pompe Disease
- Posterior Segment
- Postmenopausal Osteoporosis
- Postprandial Distress Syndrome (PDS)
- Presbyopia
- Protocol
- Protocol Amendments
- Protocol Deviations
- Prurigo Nodularis
- Pruritus
- Psoriasis
Q
- Quality Assurance (QA)
- Quality Control (QC)
- Query
R
- Randomization
- Randomization and Trial Supply Management (RTSM)
- RECIST
- Recruitment Plan
- Retention Plan
- Retina
- Retinal Vein Occlusion (RVO)
- Rheumatoid Arthritis (RA)
- Rheumatology
- Risk Based Quality Management
- Rosacea
- Route of Administration
S
- Safety Monitoring Plan
- SCC (Squamous Cell Carcinoma)
- Scleroderma
- SCORAD Assessment
- Screening Log
- Screening Process
- Skin Cancer
- Source Data Verification (SDV)
- Source Document
- Spinal Cord Hemorrhage
- Spinal Cord Ischemia 
- Standard Operating Procedure (SOPs)
- Stopping Rules
- Stratification
- Stroke
- Sub-I (The Sub-Investigator)
- Subcutaneous Fat
- Subjective Endpoints
- Swimmer’s Itch (Cercarial Dermatitis)
- Synthetic Control Arm
T
- Telangiectasia
U
- Ulcerative Colitis
- Unmasking/Unblinding
- Urodynamics
- Uvea
V
- Vascular Neurology
- Verneuil’s Disease
- Vertical Neck Bands
- Vitiligo
- Vitreoretinal
- Vitreous
W
- Warts
- Web Response System (WRS)

Glossary of Clinical Trial Terms

21 CFR Part 11

Abbreviated New Drug Application (ANDA)

Acid Reflux

Adverse event

Adverse Event Grading

Age-Related Macular Degeneration (AMD)

Aging Hands

Alopecia Areata

Anterior Segment

Arm

Astigmatism

Atopic Dermatitis

Basal Cell Carcinoma

Baseline

Bias

Biologic

Biologic License Application

BLA

Case Report Form (CRF)

Cataract

Celiac Disease

Centralized Monitoring

Checkpoint Inhibitors

Clear Cell Renal Cell Carcinoma (CCRCC)

Clinical Research

Clinical Research or Study Coordinator (CRC)

Clinical Study Build

Clinical Trial

ClinOps (Clinical Operations)

Colon cancer

Companion Diagnostics CDx

Concomitant Medication

Conflict of Interest

Conjunctivitis

Control Group

Controlled Clinical Trial

Corneal Abrasion/Ulcer

CRA (Clinical Research Associates)

CRO (Contract Research Organization)

Crohn’s Disease

cSCC (Cutaneous Squamous Cell Carcinoma)

ctDNA

CTMS (Clinical Trial Management System)

Cutaneous Lupus Erythematosus

Cytokine Release Syndrome (CRS)

Dandruff

Data and Safety Monitoring Board (DSMB)

Data and Safety Monitoring Plan (DSMP)

Data Management

Data Management Plan (DMP)

Diabetic Macular Edema (DME)

Diabetic Retinopathy (DR)

Dislocated Intraocular Lens (IOL)

Double Chin

Double Negative Breast Cancer

Dry Eye Syndrome

EASI Score

eConsent

Eczema

EDC

Edema

Efficacy

Electronic Clinical Outcome Assessment (eCOA)

Electronic Source (eSource)

Eligibility Criteria

Endometriosis

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Endpoint

Enrollment

Epilepsy

Epileptologists

ePRO (Electronic Patient-Reported Outcome)

Erythema

eTMF

Fibrosis

Fingernail Psoriasis

Food and Drug Administration (FDA)

Gastroenterology

Gene therapy

Glossary
of Clinical Trial Terms

Acid Reflux 

Colon cancer 

IND-Enabling Trial 

Inflammatory Myopathies 

Liver cirrhosis 

Nonalcoholic fatty liver disease (NAFLD) 

Nonalcoholic Steatohepatitis (NASH) 

Pediatric Neurology 