A
- Accountability
- Active substance of biotechnological origin
- Active substance of chemical origin
- Active Substance (AS)
- Adolescents (12-17 years)
- Adults (18-64 years)
- Advanced Therapy Investigational Medicinal Products (ATIMP)
- Adverse Event
- Amendments of protocol
- Anatomic, therapeutic, chemical (ATC)
- Application for a Clinical Research to EC
- Archiving
C
- CE mark
- Chemical Abstract Services (CAS) number
- Classification Code (MedDRA)
- Classification of Advanced Therapy (CAT)
- Clinicaltrials.gov
- Clinical Event Committee (CEC)
- Clinical Trial Agreement (CTA)
- Clinical Trial (CT)
- Close-Out Visit (COV)
- Comparator
- Competent Authority (CA)/ National Competent Authority (NCA) Also referred as National Medicine Regulatory Authorities
- Concentration unit
- Contract Researc Organization (CRO)
- Controlled
- Core lab or External Laboratory selection
- Countries in which trial sites are planned
- Country which granted the Marketing Authorisation
- Cross over
- Current sponsor code
D
- Database Locking
- Data Cleaning
- Data Entry
- Data Management
- Data Management Plan
- Data Monitoring Committee
- Data Safety Monitoring (DSMB)
- Date of Competent Authority Decision
- Date of Ethics Committee Opinion
- Date of the global end of the trial
- Description of the IMP
- Diagnosis
- Dose response
- Double blind
E
F
H
I
- IEC Opinion of amendment
- Immunological medicinal product
- IMP to be used in the trial has a marketing authorisation
- Infants and toddlers (28 days-23 months)
- INN – Proposed INN
- Insurance Policy
- Interactive Voice Response System (IVRS)
- International Standard Randomised Controlled Trial Number (ISRCTN)
- Interventional trial
- Investigational Medicinal Product (IMP)
- Investigator
- Investigator Meeting
- In Utero
- In Vivo
M
- Main objective of the trial
- Marketing Authorisation
- Marketing Authorisation Holder (MAH)
- MedDRA Classification
- MedDRA Level
- Medical condition in easily understood language
- Medical condition(s) investigated
- Monitoring Plan
- Multinational trial
- Multiple Member States
- Multiple sites in the Member State concerned
N
P
- Paediatric Investigation Plan (PIP)
- Parallel group
- Patient Fee
- Pharmaceutical form
- Pharmacodynamic
- Pharmacoeconomic
- Pharmacogenetic
- Pharmacogenomic
- Pharmacokinetic
- PIP
- PIP Addressee/Addressee of PIP Decision
- Placebo
- Planned number of subjects
- Plasma derived medicinal product
- Post Trial Treatment
- Preterm newborn infants
- Primary end point(s)
- Principal exclusion criteria
- Principal inclusion criteria
- Product code
- Product name
- Prophylaxis
- Proposed date of start of recruitment
- Protocol
- Protocol Synopsis
R
S
- Safety
- Sample Size
- Scope of the trial
- Secondary end point(s)
- Secondary objectives of the trial
- Single blind
- Single site in the Member State concerned
- Site Initiation Visit (SIV)
- Site Monitoring
- Site Selection
- Somatic cell therapy medicinal product
- Source(s) of Monetary or Material Support for the clinical trial
- Specific paediatric formulation
- Specific vulnerable populations
- Sponsor
- Sponsor Country
- Sponsor’s protocol code number
- Start Date
- Statistical Analysis
- Statistical Analysis Plan (SAP)
- Status of the sponsor
- Study
- Study Report
- Study’s Training
- Subject
- Subjects incapable of giving consent personally
- Summary of Product Characteristics (SmPC)