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
- Active Pharmaceutical Ingredient (API)
- Adaptive Clinical Trial Design
- Adaptive Design
- Adherence
- Adverse Event
- Adverse Event of Special Interest (AESI)
- Adverse Event Reporting
- ALCOA+ Principles
- Amendment
- Analysis Population
- Arm (study arm)
- Audit / Inspection
- Audit Plan
- Audit Report
- Audit trail
- Authorized Representative
b
c
- Case Management
- Case Report Form
- CDISC Standards
- CE Marking
- Central Laboratory
- Central Monitoring
- Certificate of Analysis (CoA)
- Clinical Data Management
- Clinical Development Plan
- Clinical Evaluation Report (CER)
- Clinical Monitor
- Clinical Monitoring
- Clinical Pharmacology
- 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
- Comparator
- Comparator Drug
- Compassionate Use
- Compliance
- Computerized System Validation
- Conditional Marketing Authorisation
- Confidence Interval
- Consent of Minors
- Contract Research Organization
- Control Group
- Corrective and Preventive Action
- Crossover Design
- Crossover Study
d
- Data Integrity
- Data Management Plan
- Data Monitoring Committee
- Data Safety Monitoring Board (DSMB)
- Database Lock
- Decentralized Clinical Trial
- Decentralized clinical trials
- Declaration of Helsinki
- Development Safety Update Report (DSUR)
- Digital Biomarker
- Dose Escalation
- Dose Escalation
- Double-blind
- Drug Accountability
- Drug Development
- Drug-Drug Interaction
e
- eConsent (Electronic Consent)
- Efficacy
- Efficacy
- Electronic Case Report Form
- Electronic Common Technical Document
- Electronic Data Capture
- Electronic Patient-Reported Outcome
- Endpoint
- Endpoint Adjudication
- Essential Documents
- Estimand
- Ethics Committee
- EU MDR 2017/745 (Medical Device Regulation)
- EU Regulation 536/2014 (Clinical Trials Regulation)
- Evidence Synthesis
- Evidence Synthesis
- Exposure-Response
- Extrapolation
f
g
i
- Immunogenicity
- Imputation
- In-Vitro Diagnostics Regulation (IVDR)
- Inclusion and Exclusion Criteria
- Informed Consent
- Informed Consent Form
- Intention-to-Treat Analysis (ITT)
- 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
- P-Value
- Paediatric Investigation Plan (PIP)
- Parallel Design
- Patient Centricity
- Patient Recruitment
- Patient-Reported Outcome (PRO)
- Pediatric Investigation Plan
- Per-Protocol Analysis
- Per-protocol population
- Performance Evaluation
- Performance Study
- Periodic Safety Update Report (PSUR)
- Pharmacodynamics
- Pharmacodynamics
- Pharmacokinetics
- Pharmacokinetics
- Pharmacovigilance
- Phase 0 study
- Phytotherapy
- Placebo
- Post-Authorisation Safety Study
- Post-hoc Analysis
- Post-Market Clinical Follow-up (PMCF)
- Power Calculation
- Pragmatic Trial
- Pre-Study Visit (PSV)
- Precision Medicine
- Preclinical Development
- Primary endpoint
- Principal Investigator (PI)
- Progression-Free Survival
- Proof of Concept (PoC)
- Protocol deviation
- Protocol deviation
- Protocol Violation
- Publication Bias
q
r
s
- Safety Database
- Safety Monitoring
- Sample Size
- Sample Size Justification
- Scientific Advice
- Screening
- Secondary Endpoint
- Sensitivity Analysis
- Serious Adverse Event
- Serious Adverse Event
- Serious Adverse Reaction (SAR)
- Single-arm study
- Site Close-Out Visit (COV)
- Site Initiation Visit (SIV)
- Site Management Organisation
- Source Data Verification
- Sponsor
- Standard Operating Procedure (SOP)
- Statistical Analysis Plan
- Statistical Power
- Steering Committee
- Stratification
- Study Budget
- Study Coordinator
- Study Coordinator
- Study Discontinuation
- Study Start-Up
- Subgroup Analysis
- Superiority Trial
- Superiority Trial
- Surrogate Endpoint
- Survival Analysis
- Suspected Unexpected Serious Adverse Reaction (SUSAR)
t