Clinical Trials Glossary: Technical Terms in Clinical Research from A to Z
Our Overview of Various Technical Terms
This glossary contains key technical terms from clinical research, from the planning and execution of clinical trials through data collection, monitoring, and evaluation to approval and subsequent post-market surveillance. The terms are arranged alphabetically and clearly explained, enabling both professionals and newcomers to quickly gain a structured overview of clinical trial terminology.
a
b
c
- Case Report Form
- CDISC Standards
- Central Laboratory
- Clinical Data Management
- Clinical Development Plan
- Clinical Monitor
- Clinical Monitoring
- Clinical Phases I-IV
- Clinical Project Management
- Clinical Study Protocol
- Clinical Study Report
- Clinical Trial Application
- Clinical Trial Supplies Logistics
- Clinical Trials Information System (CTIS)
- Common Adverse Reactions
- Comparability Exercise
- Compliance
- Computerized System Validation
- Confidence Interval
- Contract Research Organization
- Control Group
- Corrective and Preventive Action
d
e
i
- Immunogenicity
- Imputation
- Informed Consent
- Informed Consent Form
- Interactive Voice/Web Response System
- Interim Analysis
- International Council for Harmonisation
- Investigational Medicinal Product (IMP)
- Investigational Medicinal Product Dossier
- Investigational Site
- Investigator-Initiated Trial
- Investigator’s Brochure
- IXRS (Interactive Response Technology)
l
m
- Marketing Authorisation Application
- Marketing Authorization
- Master Protocol
- Maximum Tolerated Dose
- MedDRA
- Median
- Medical Device
- Medical Writing
- Medicinal product safety
- Meta-analysis
- Minimal Clinically Important Difference (MCID)
- Missing Data
- Mixed Methods
- Modeling and Simulation
- Monitoring Plan
- Mortality
- Multicenter Study
- Multivariate Analysis
n
o
p
- Paediatric Investigation Plan (PIP)
- Parallel Design
- Patient Centricity
- Patient-Reported Outcome (PRO)
- Pediatric Investigation Plan
- Per-protocol population
- Performance Evaluation
- Performance Study
- Pharmacodynamics
- Pharmacodynamics
- Pharmacokinetics
- Pharmacokinetics
- Pharmacovigilance
- Phase 0 study
- Phytotherapy
- Placebo
- Post-Authorisation Safety Study
- Post-hoc Analysis
- Power Calculation
- Pragmatic Trial
- Precision Medicine
- Preclinical Development
- Primary endpoint
- Principal Investigator (PI)
- Progression-Free Survival
- Proof of Concept (PoC)
- Protocol deviation
- Protocol deviation
- Protocol Violation
- Publication Bias
r
s
- Safety Database
- Safety Monitoring
- Sample Size
- Sample Size Justification
- Screening
- Secondary Endpoint
- Sensitivity Analysis
- Serious Adverse Event
- Serious Adverse Event
- Single-arm study
- Site Management Organisation
- Source Data Verification
- Sponsor
- Standard Operating Procedure (SOP)
- Statistical Analysis Plan
- Steering Committee
- Stratification
- Study Budget
- Study Coordinator
- Study Coordinator
- Study Start-Up
- Subgroup Analysis
- Superiority Trial
- Surrogate Endpoint
- Survival Analysis
- Suspected Unexpected Serious Adverse Reaction (SUSAR)
t