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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Acne
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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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Adjuvant Therapy
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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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Alopecia Areata
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Alzheimer’s Disease
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Angina Pectoris
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Angiogenesis
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Anterior Segment
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Antibody-Drug Conjugates
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Anticoagulation
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Antihistamines
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Apocrine Glands
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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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B-lymphocytes
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Basal Cell Carcinoma
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Baseline
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Benign Tumor
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Bias
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Biologic
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Biologic License Application
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Biologic Response Modifiers (BRMs)
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Biomarker
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Biomarker-Driven Randomization to Target Subjects
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Biomarker-Driven Therapies
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Biosimilars
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Birthmark
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BLA
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Blisters
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Blood-Brain Barrier (BBB)
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Blue Light Therapy
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Bone Marrow Aspiration
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Botox
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Branch Retinal Vein Occlusion (BRVO)
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Bullae
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Bullous Pemphigoid
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C
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Calluses
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Cancer
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Cancer Vaccines
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Candidiasis
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Capsule Endoscopy
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CAR T-Cell Therapy
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Carbon Dioxide (CO2) Laser Resurfacing
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Carbuncle
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Carcinoembryonic Antigen (CEA)
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Carcinogens
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Carcinoma
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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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Cellulite
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Cellulitis
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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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Chemical Peel
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Chemical Reconstruction of Skin Scars (CROSS)
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Chemoprevention
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Chemotherapy
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Cherry angiomas
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Chimeric Antigen Receptor (CARs)
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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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Collagen
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Colon cancer
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Colonoscopy
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Companion Diagnostics CDx
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Complementary and Alternative Medicine (CAM)
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Computed Tomography (CT or CTA scan)
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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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Contact Dermatitis
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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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Corticosteroid Creams
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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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Cryotherapy
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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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Cyst
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Cystic Fibrosis
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Cytokine Release Syndrome (CRS)
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D
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Dandruff
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Data and Safety Monitoring Board (DSMB)
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Data and Safety Monitoring Plan (DSMP)
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Data Management
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Data Management Plan (DMP)
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Deep Vein Thrombosis (DVT)
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Dermabrasion
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Dermal Fillers
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Dermatitis
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Dermatofibroma
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Dermatologist
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Dermatology
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Dermatomes
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Dermis
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Dermoscopy
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Device-Based Therapeutics
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Diabetes Mellitus
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Diabetic Macular Edema (DME)
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Diabetic Retinopathy (DR)
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Diarrhea
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Dislocated Intraocular Lens (IOL)
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Double Chin
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Double Negative Breast Cancer
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Dry Eye Syndrome
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Duodenal Ulcer
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Dyslipidemia
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Dysplasia
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Dysplastic Nevus
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E
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EASI Score
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Eccrine glands
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eConsent
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Eczema
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Eczema
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EDC
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Edema
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Efficacy
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Elastin
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Electrodesiccation
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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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Eosinophilic Esophagitis
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Epidermis
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Epigenomics
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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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Erythrocytes
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Esophagitis
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eTMF
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H
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Hair Follicle
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Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
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Healthy volunteers
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Heart Failure (HF)
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Helical Computed Tomography (Helical CT)
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Heloma (Corn)
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Hemangioma
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Hepatocellular Carcinoma (HCC)
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Hepatology
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Herpes Simplex
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Herpes Zoster
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Herpes Zoster (Shingles)
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Hidradenitis suppurativa
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High-Dose Radiation Therapy (HDR)
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Hirsutism
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Histopathology
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Hives
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Human Subject
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Hyperhidrosis
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Hyperkeratosis
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Hyperlipidemia
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Hyperopia
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Hyperpigmentation
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Hyperpigmentation
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Hypertension
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Hypertrophic Cardiomyopathy (HCM)
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Hypodermis (Subcutaneous Layer)
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Hypopigmentation
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Hypoxia
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I
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Ichthyosis
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Immuno-oncology
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Immunodeficiency
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Immunology
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Immunosuppression
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Immunotherapy
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Impetigo
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In Vitro Diagnostics (IVDs)
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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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Intertrigo
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Interventional Cardiology
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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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M
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Macula
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Malignant Tumor
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Mammography
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Masking/Blinding
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Mastectomy
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Maternal-Fetal Medicine
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Melanin
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Melanoma
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Metabolomics
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Metastasis
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Methicillin-resistant Staphylococcus aureus (MRSA)
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mHealth
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Microbiome
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Microdermabrasion
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Microneedling
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Midface Volume Deficit
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Migraines
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Molecular Profiling
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Monoclonal Antibodies
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Mortality Rate
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Motility
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Mucopolysaccharidosis
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Multiple Sclerosis (MS)
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Mutation
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Myelogram
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Myocardial Infarction
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Myocardial Perfusion Imaging (MPI)
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Myopia
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N
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National Cancer Institute (NCI)
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National Institute of Health (NIH)
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Neoadjuvant Therapy
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Neoplasm
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Nerve Conduction Studies (NCS)
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Neuroblastoma
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Neurocritical Care
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Neurodegenerative Diseases
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Neurodevelopmental Disabilities
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Neurogastroenterology
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Neuroinflammation
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Neurology
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Neuromuscular Medicine
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Neuromuscular Transmission
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Neutropenia
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Nevi (Moles)
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New Drug Application (NDA)
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Next-Generation Sequencing (NGS)
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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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Novel Cytokines
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- O
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P
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Palliative Care
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Palliative Chemotherapy
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Pancreatic Insufficiency
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Papillary Layer
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Parafollicular Cell (C cell)
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Parkinson’s Disease
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Paronychia
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Paroxysmal Supraventricular Tachycardia
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PASI Score
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Patch Testing
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PDUFA
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Pediatric Neurology
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Peptic Ulcer Disease
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Percutaneous Coronary Intervention (PCI)
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Pericytes
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Peripheral Arterial Disease/ Peripheral arterial occlusive disease
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Peripheral Nervous System (PNS)
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Peripheral Neuropathy
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Peripheral Vein Grafts
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Personalized Medicine
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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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Photodynamic Therapy (PDT)
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Phototherapy
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PI (Principal Investigator or Primary Investigator)
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Pilosebaceous Unit
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Placebo
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Placebo Controlled Study
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Plaque Psoriasis
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Plateletpheresis
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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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Pre-treatment Genomic-Based Cancer Screening
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Precision GI Medicine
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Precision Medicine
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Precision Oncology
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Presbyopia
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Proteomics
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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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Pulmonary Arterial Hypertension (PAH)
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Pulmonary Hypertension
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R
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Radiopharmaceuticals
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Randomization
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Randomization and Trial Supply Management (RTSM)
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Rash
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Real-World Data
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RECIST
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Recruitment Plan
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Renal Failure
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Retention Plan
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Retina
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Retinal disease/ Retinopathy
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Retinal Vein Occlusion (RVO)
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Retinoids
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Rheumatoid Arthritis (RA)
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Rheumatology
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Risk Based Quality Management
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Rosacea
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Rosacea
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Route of Administration
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S
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Safety Monitoring Plan
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Salicylic Acid
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SaMDs (software as a medical device)
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Scabies
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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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Sebaceous Gland
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Sebaceous Hyperplasia
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Seborrheic Dermatitis
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Sequencing
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Short Bowel Syndrome
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Skin Cancer
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Skin Grafting
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Skin Lesion
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Skin Tag
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Source Data Verification (SDV)
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Source Document
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Spider Veins
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Spinal Cord Hemorrhage
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Spinal Cord Ischemia
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ST-Elevation Myocardial Infarction (STEMI)
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Stable Angina
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Standard Operating Procedure (SOPs)
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Stopping Rules
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Stratification
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Stratum basale (basal layer)
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Stratum Corneum
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Stratum Granulosum
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Striae (Stretch Marks)
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Stroke
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Sub-I (The Sub-Investigator)
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Subcutaneous Fat
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Subcutaneous Tissue
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Subjective Endpoints
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Sunburn
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Swimmer’s Itch (Cercarial Dermatitis)
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Synthetic Control Arm
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