Glossary
This is the place to find out the common terms used in clinical research. There are more than 200 related terms arranged in alphabetical order. Select and click the term to know the meaning from the dropdown of each alphabet.
A
B
Select the Term
Bias
Bioavailability
Bioequivalence Study
Biometrics
Biostatistics
Black List
Blind Review
Blinding
Brand Name
C
Select the Term
Clinical Significance
Case Report Form
Center for Drug Evaluation and Research
Central Laboratory
Central Office for Research Ethics Committees
Certificate of Analysis
CFR 21CFR part 50
CFR: 21CFR part 11
CFR: 21CFR part 312
Challenge agent
Clinical Research Associate
Clinical Trial Materials
Close Down/Close Out
Clinical Trial/Study Report
Code Break
Cohort study
Comparator
Compliance
Concomitant Medication
Concomitant Treatment
Confidentiality
Consent Form
Contract Research Organization
Control Group
Coordinating Investigator
CRA Visit Log
D
Select the Term
Data and Safety Monitoring Board
Data Handling
Data Monitoring Committee
Data Query
Database
Direct Access
Discontinuation of a Trial Subject
Dose Response Curve
Dosing Schedule
Double Blind Trial
Double Data Entry
Double Dummy Technique
Drop Out
Drug
Drug Accountability
Drug of Choice
Drug Level
Drug Development
Drug Accountability
Data
E
Select the Term
Efficacy
Eligible Subjects
Endpoints
Equivalence Trial
Enteric Coating
Escape Medication
Essential Documents
Ethical Drugs
Evidence Based Medicine
Exclusion Criteria
F
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FDA 1572
Feasibility
Financial Agreement
Financial Disclosure
First-in-Man Trial
Food & Drug Administration
Full Analysis Set
G
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Generic Name
GCP Guidelines
H
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Half Life
Hawthorne Effect
Hazard Ratio
Historical Control
Holter Monitoring
Hypothesis
I
Select the Term
ICH GCP
Inclusion Criteria
Indemnity
Initiation Visit
Institutional Review Board
Informed Consent
Intent to Treat
Interaction
Invasive Procedure
Investigational Medicinal Product
Investigational New Drug
Investigator
Investigator's Brochure
Investigator Site File
K
Select the Term
Kaplan-Meier
L
Select the Term
Labeling
Laboratory Data
Laboratory Normal Ranges
Legally Acceptable Representative
Liability
Loading Dose
Logistic Regression
Lost to follow up
M
Select the Term
Manufacturing Authorisation
Manufacturing Authorisation for Investigational Medicinal Product
Marketing Authorisation
Masking
MedDRA
Medical Adviser
Medical History
Medicinal Product
Medicines and Healthcare Regulatory Authority
Metabolism
Minimum Effective Concentration
Minimum Toxic Concentration
Missing Data
Monitor
Monitoring Visit Report
Monitor's Visit Log
Mutagenicity Testing
Multicentre Trial
N
Select the Term
Named Patient Basis
New Chemical Entity
New Drug Application
Nominal Data
Non Investigational Medicinal Product
Non clinical Studies
Non Comparative Trial
Non Evaluable Patient
Non-Interventional trial
Non-Invasive Procedure
Non-Therapeutic Trial
Nuremberg Code
O
Select the Term
Objective Measurement
Off-label
Open Trial/Open Label
Opinion Leader
Optimum Dose
Ordinal Data
Orphan Drug
Over-the-counter
P
Select the Term
Package Insert
Paediatric Investigation Plan
Parallel Group Trial
Partial Responder
Patient Information Leaflet
Patient Recruitment
Pharmacodynamics
Pharmacokinetics
Pharmacologist
Pharmacovigilance
Pivotal Trial
Placebo
Placebo Effect
Post Marketing Surveillance
Preclinical
Prescription Only Medicine
Principal Investigator
Protocol
Protocol Amendment
Protocol Deviation
Protocol Violation
Q
Select the Term
Qualitative Data
Quality Assurance
Quality Control
Quality of Life
Quantitative Data
Quarantine
R
Select the Term
Randomisation
Regulatory Affairs
Regulatory Approval
Retrospective Trial
Risk/Benefit Ratio
Route of Administration
Run In Period
S
Select the Term
Serious Adverse Event
Significance Test
Single Blind Trial
Site Management Organisation
Source Data
Source Data Verification
Source Documents
Sponsor
Study Site Coordinator
Subject
Subject Identification Code
Suspected Serious Adverse Reaction
T
Select the Term
Therapeutic Area
Time Point
Tolerance
Toxicity
Trial Initiation
Trial Master File
U
Select the Term
Unexpected Adverse Reaction
Unblinding
Unrestricted Randomisation
V
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Variance
Verification of Data
Visit
Vulnerable Subjects
W
Select the Term
Washout Period
Well-being (of the trial subjects)
Witnessed Verbal Consent
