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
- Adverse event
- Age-Related Macular Degeneration (AMD)
- Aging Hands
- Alopecia Areata
- Anterior Segment
- Arm
- Astigmatism
B
- Basal Cell Carcinoma
- Baseline
- Bias
- Biologic
C
- Case Report Form (CRF)
- Cataract
- Celiac Disease
- Clinical Research
- Clinical Research or Study Coordinator (CRC)
- Clinical Trial
- ClinOps (Clinical Operations)
- Concomitant Medication
- Conflict of Interest
- Conjunctivitis
- Control Group
- Controlled Clinical Trial
- Corneal Abrasion/Ulcer
- CRA (Clinical Research Associates)
- CRO (Contract Research Organization)
- CTMS (Clinical Trial Management System)
- Cutaneous Lupus Erythematosus
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
- Dry Eye Syndrome
E
- Eczema
- EDC
- Efficacy
- Eligibility Criteria
- Endometriosis
- Endpoint
- Enrollment
- Epilepsy
- ePRO (Electronic Patient-Reported Outcome)
F
- Fingernail Psoriasis
- Food and Drug Administration (FDA)
G
- Gastroenterology
- Glaucoma
- Good Clinical Practice (GCP)
- Gynecology
H
- Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
- Healthy volunteers
- Hidradenitis suppurativa
- Hives
- Human Subject
- Hyperopia
- Hyperpigmentation
I
- Inclusion/Exclusion criteria
- Informed Consent
- Informed Consent Form
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
- Investigational New Drug Application (IND)
- Irritable Bowel Syndrome (IBS)
- IRT (Interactive Response technology)
K
- Keloids
- Keratoconus
L
- Lactose Intolerance
- Lupus
M
- Macula
- Masking/Blinding
- Midface Volume Deficit
- Multiple Sclerosis (MS)
- Myopia
N
- Neurology
- New Drug Application (NDA)
O
- Office for Human Research Protection (OHRP)
- Open-Label Trial
- Ophthalmology
- Optic Nerve
- Osteoarthritis
P
- Parkinson’s Disease
- Pharmacokinetics
- Phase I
- Phase II
- Phase III
- Phase IV
- PI (Principal Investigator or Primary Investigator)
- Placebo
- Placebo Controlled Study
- Posterior Segment
- Presbyopia
- Protocol
- Protocol Amendments
- Protocol Deviations
- Prurigo Nodularis
- Pruritus
- Psoriasis
Q
- Quality Assurance (QA)
- Quality Control (QC)
R
- Randomization
- Recruitment Plan
- Retention Plan
- Retina
- Retinal Vein Occlusion (RVO)
- Rheumatoid Arthritis (RA)
- Rheumatology
- Rosacea
S
- Safety Monitoring Plan
- Screening Log
- Screening Process
- Skin Cancer
- Source Document
- Standard Operating Procedure (SOPs)
- Stopping Rules
- Stratification
- Stroke
- Sub-I (The Sub-Investigator)
- Subcutaneous Fat
U
- Unmasking/Unblinding
- Uvea
V
- Verneuil’s Disease
- Vertical Neck Bands
- Vitiligo
- Vitreoretinal
- Vitreous
W
- Warts

Glossary of Clinical Trial Terms

21 CFR Part 11

Adverse event

Age-Related Macular Degeneration (AMD)

Aging Hands

Alopecia Areata

Anterior Segment

Arm

Astigmatism

Basal Cell Carcinoma

Baseline

Bias

Biologic

Case Report Form (CRF)

Cataract

Celiac Disease

Clinical Research

Clinical Research or Study Coordinator (CRC)

Clinical Trial

ClinOps (Clinical Operations)

Concomitant Medication

Conflict of Interest

Conjunctivitis

Control Group

Controlled Clinical Trial

Corneal Abrasion/Ulcer

CRA (Clinical Research Associates)

CRO (Contract Research Organization)

CTMS (Clinical Trial Management System)

Cutaneous Lupus Erythematosus

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

Dry Eye Syndrome

Eczema

EDC

Efficacy

Eligibility Criteria

Endometriosis

Endpoint

Enrollment

Epilepsy

ePRO (Electronic Patient-Reported Outcome)

Fingernail Psoriasis

Food and Drug Administration (FDA)

Gastroenterology

Glaucoma

Good Clinical Practice (GCP)

Gynecology

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

Healthy volunteers

Hidradenitis suppurativa

Hives

Human Subject

Hyperopia

Hyperpigmentation

Inclusion/Exclusion criteria

Informed Consent

Informed Consent Form

Institutional Review Board (IRB)/Independent Ethics Committee (IEC)

Investigational New Drug Application (IND)

Irritable Bowel Syndrome (IBS)

IRT (Interactive Response technology)

Keloids

Keratoconus

Lactose Intolerance

Lupus

Macula

Masking/Blinding

Midface Volume Deficit

Multiple Sclerosis (MS)

Myopia

Neurology

New Drug Application (NDA)

Glossary
of Clinical Trial Terms

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