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
- Accelerated Assessment
- Active medical device
- Active Pharmaceutical Ingredient (API)
- Active Substance Master File
- Adaptive Clinical Trial Design
- Adaptive Design
- Additional Monitoring and Black Triangle
- Additional Risk Minimisation Measures
- Adherence
- Advanced Therapy Medicinal Products
- Adverse device effect and expected serious adverse
- Adverse Event
- Adverse Event of Special Interest (AESI)
- Adverse Event Reporting
- ALCOA+ Principles
- Alpha Spending Function
- Amendment
- Analysis Data Model
- Analysis Population
- Analysis Results Standard
- Analytical Performance
- Annual Re-assessment
- Arm (study arm)
- Aseptic Process Simulation
- Assay Sensitivity
- ATC Classification and Defined Daily Dose
- Audit / Inspection
- Audit Plan
- Audit Report
- Audit trail
- Audit Trail Review
- Authorized Representative
- Auxiliary medicinal product
b
- Baseline
- Basket, Umbrella, and Platform Trials
- Batch certification by the Qualified Person
- Bayesian Statistics
- Benefit-Risk Assessment
- Bias
- Bibliographical Application
- Bioavailability
- Biocompatibility of medical devices
- Bioequivalence
- Biological Evaluation of Medical Devices
- Biomarker
- Biomedical Concepts
- Biosimilar
- Biostatistics
- Biotechnology
- Blinded Endpoint Committee
- Blinded investigational medicinal product
- Blinding
- Bracketing and Matrixing
- Breakthrough Therapy Designation
c
- Case Management
- Case Report Form
- CDASH
- CDISC CORE and Conformance Rules
- CDISC Standards
- CE Marking
- Central Laboratory
- Central Monitoring
- Centralised Procedure
- Certainty of conclusions: indication, hint, proof
- Certificate of Analysis (CoA)
- Certified Copy
- Change control for medical devices
- Classification rules for medical devices
- Clinical Data Management
- Clinical Development Plan
- Clinical Evaluation as an MDR Process
- Clinical Evaluation of Software as a Medical Device
- Clinical Evaluation Report (CER)
- Clinical Investigation of Medical Devices According to ISO 14155
- Clinical investigation under Article 74 MDR
- Clinical Monitor
- Clinical Monitoring
- Clinical Performance
- 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)
- Cluster trial
- Co-sponsorship
- Committee for Advanced Therapies
- Common Adverse Reactions
- Common Specifications
- Comparability Exercise
- Comparator
- Compassionate Use
- Competing Risks and Subdistribution Hazard
- Complaint Management for Medical Devices
- Compliance
- Computerized System Validation
- Concomitant Toxicokinetics
- Conditional Marketing Authorisation
- Confidence Interval
- Confirmation according to Annex 16
- Conformity assessment procedures for medical devices
- Consent of Minors
- CONSORT 2025
- Continual Reassessment Method
- Contract Research Organization
- Control Group
- Controlled Terminology
- CORE Reference
- Corrective and Preventive Action
- Critical Quality Factors
- Crossover Study
- CTCAE
- Cumulative Incidence Function
- Custom-Made Medical Devices
- Cybersecurity for Medical Devices
d
- Data Collection Tool
- Data Governance in Clinical Trials
- Data Integrity
- Data Lock Point
- Data Management Plan
- Data Monitoring Committee
- Data Safety Monitoring Board (DSMB)
- Data Transfer, Data Exchange, and Data Migration
- Database Lock
- Dataset-JSON
- Day 0
- Day 120 List of Questions and Clock Stop
- Decentralised Procedure
- Decentralized Clinical Trial
- Declaration of Helsinki
- Deferred Consent in Emergency Situations
- Define-XML
- Delegation of Authority Log
- Design History File for a Medical Device
- Design Validation of Medical Devices
- Design Verification of Medical Devices
- Designated Medical Event
- Development Safety Update Report (DSUR)
- Device History Record
- Device Master Record of a Medical Device
- Digital Biomarker
- Digital Data Flow and Unified Study Definitions Model
- Disproportionate reporting
- Distributors of Medical Devices
- Document Control in the Medical Device QMS
- Dose Escalation
- Dose-Limiting Toxicity
- 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
- Emerging Safety Issue
- Endpoint
- Endpoint Adjudication
- Equivalence
- Essential Documents
- Established technology
- Estimand
- Ethics Committee
- Ethylene Oxide Sterilization of Medical Devices
- EU Declaration of Conformity
- EU MDR 2017/745 (Medical Device Regulation)
- EU Regulation 536/2014 (Clinical Trials Regulation)
- EU-M4all
- EUDAMED
- EudraVigilance
- European Health Data Space
- Evidence Synthesis
- Exposure-Response
- Extension of the Marketing Authorisation
- Extrapolation
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i
- Immediate Hazard
- Immortal Time Bias
- Immunogenicity
- Impartial Witness
- Implantable Medical Device
- Important Protocol Deviation
- Importer of medical devices
- Imputation
- In-Vitro Diagnostics Regulation (IVDR)
- Incident and Serious Incident
- Inclusion and Exclusion Criteria
- Indemnification
- Individual Case Safety Report
- Informed Consent
- Informed Consent Form
- Instructions for Use for Medical Devices
- Intended purpose of a medical device
- Intention-to-Treat Analysis (ITT)
- Intercurrent Events
- Interim Analysis
- Internal audit in the medical device quality management system
- International Council for Harmonisation
- Invasive Medical Device
- Investigational Device
- Investigational Medicinal Product (IMP)
- Investigational Medicinal Product Dossier
- Investigational Site
- Investigator Site File
- Investigator-Initiated Trial
- Investigator’s Brochure
- IXRS (Interactive Response Technology)
l
m
- Manufacturer Inspection under MDR
- Market Exclusivity for Orphan Medicinal Products
- Marketing Authorisation Application
- Marketing Authorisation Under Exceptional Circumstances
- Marketing Authorization
- Master Protocol
- Maximum Tolerated Dose
- MDR Compliance Service Provider
- MDR Transitional Period
- MedDRA
- Median
- Medical Device
- Medical Device Coordination Group
- Medical Device Directive
- Medical Device Software
- Medical Device Vigilance System
- Medical Writing
- Medication Error
- Medicinal product safety
- Medicinal Substance as an Integral Part of a Device and the Consultation Procedure
- Meta-analysis
- Meta-analytic predictive prior
- Minimal Clinically Important Difference (MCID)
- Minimal-intervention clinical trial
- Missing Data
- Missing Not at Random (MNAR)
- Mixed Methods
- Mixed Model for Repeated Measures
- Modeling and Simulation
- Monitoring Plan
- Mortality
- Multicenter Study
- Multivariate Analysis
- Mutual Recognition Procedure
n
o
p
- P-Value
- Paediatric Investigation Plan (PIP)
- Parallel Design
- Patient Centricity
- Patient Recruitment
- Patient-Reported Outcome (PRO)
- Per-Protocol Analysis
- Per-protocol population
- Performance Evaluation
- Performance Study
- Performance study plan and performance study device
- Periodic Safety Update Report (PSUR)
- Periodic Safety Update Report for Medical Devices
- Periodic Summary Report
- Person Responsible for Regulatory Compliance
- Person responsible for regulatory compliance
- Pharmacodynamics
- Pharmacokinetics
- Pharmacovigilance
- Pharmacovigilance Plan
- Pharmacovigilance Risk Assessment Committee
- Pharmacovigilance System Master File and QPPV
- Phase 0 study
- Phytotherapy
- Placebo
- Plain Language Summary of Results
- Post-Authorisation Safety Study
- Post-Authorization Efficacy Study
- Post-hoc Analysis
- Post-Market Clinical Follow-up (PMCF)
- Post-Market Surveillance Plan under MDR
- Post-Market Surveillance Report for Class I Products
- Post-Market Surveillance under the MDR
- Power Calculation
- Power Prior
- Pragmatic Trial
- Pre-INN (proposed International Nonproprietary Name)
- Pre-Study Visit (PSV)
- Precision Medicine
- Preclinical Development
- Primary Analysis
- Primary endpoint
- PRIME
- Principal Investigator (PI)
- Principal Stratum Strategy
- Product Defect
- Products without a medical intended purpose and products with a dual intended purpose
- Progression-Free Survival
- Proof of Concept (PoC)
- Propensity Score
- Protocol Assistance
- Protocol deviation
- Protocol Violation
- PSUR Single Assessment
- Publication Bias
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- Random Sample
- Randomization
- Randomization List
- Rapporteur and Co-Rapporteur
- Real-World Data
- Real-World Evidence (RWE)
- Recruitment Rate
- Red Hand Letter
- Reference Member State and Concerned Member State
- Reference Safety Information
- Reference-Based Imputation
- Referral Procedure
- Regression
- Regulatory Affairs
- Regulatory Strategy for Medical Devices
- Regulatory Submission
- Relative Risk
- Remote Monitoring
- Renewal of the Marketing Authorisation
- Replication
- Reprocessable medical device
- Residual risk of a medical device
- Restricted Mean Survival Time
- Risk classes of medical devices
- Risk Management for Medical Devices
- Risk Management Plan (RMP)
- Risk Ratio
- Risk-Based Monitoring
- Rule 11
s
- Safety Concerns
- Safety Database
- Safety Monitoring
- Safety Profile of a Medical Device
- Safety Specification
- Sample Size
- Sample Size Justification
- Sample Size Re-estimation
- Scientific Advice
- Scientific Validity of an Analyte
- Screening
- Secondary Endpoint
- SEND
- Sensitivity Analysis
- Serious Adverse Event (SAE)
- Serious Adverse Reaction (SAR)
- Serious Breach
- Service Provider
- Signal Validation
- Single-arm study
- Site Close-Out Visit (COV)
- Site Initiation Visit (SIV)
- Site Management Organisation
- Software Lifecycle according to IEC 62304
- Solicited report
- Source Data Verification
- Sponsor
- Sponsor Oversight
- Sponsor-Investigator
- Spontaneous Report
- Standard Operating Procedure (SOP)
- Standardised MedDRA Query
- State of the Art
- Statistical Analysis Plan
- Steam Sterilization of Medical Devices
- Steering Committee
- Stepped Wedge Design
- Sterile medical device
- Sterility Assurance Level for Medical Devices
- Stratification
- Study Budget
- Study Coordinator
- Study Data Tabulation Model
- Study Discontinuation
- Study Start-Up
- Subgroup Analysis
- Summary of Product Characteristics and QRD Template
- Summary of Safety and Clinical Performance
- Sunset Clause
- Superiority Trial
- Supplier Qualification for Medical Devices
- Surrogate Endpoint
- Survival Analysis
- Suspected Unexpected Serious Adverse Reaction (SUSAR)
- Swiss Approval Pathway for Medical Devices
- Symbols on Medical Devices
t
- Target Trial Emulation
- Technical Documentation for Medical Devices
- Temporary Halt
- Therapeutic area
- Therapeutic Area User Guide
- Time-to-Event
- Tipping Point Analysis
- Toxicity
- Traceability of medical devices
- Transfer of Sponsor Tasks
- Translational Research
- Treatment Allocation
- Treatment Emergent Adverse Event
- Treatment Policy Strategy
- Treatment Switching Adjustment
- Trend report
- Trial Master File (TMF)
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