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-
Accountability -
Active Substance (AS) -
Active substance of biotechnological origin -
Active substance of chemical origin -
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 -
Archiviazione
D
-
Data Cleaning -
Data Entry -
Gestione dei dati -
Data Management Plan -
Data Monitoring Committee -
Data Safety Monitoring (DSMB) -
Database Locking -
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
I
-
IEC Opinion of amendment -
Immunological medicinal product -
IMP to be used in the trial has a marketing authorisation -
In Utero -
In Vivo -
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
C
-
CE mark -
Chemical Abstract Services (CAS) number -
Classification Code (MedDRA) -
Classification of Advanced Therapy (CAT) -
Clinical Event Committee (CEC) -
Clinical Trial (CT) -
Clinical Trial Agreement (CTA) -
Clinicaltrials.gov -
Visita di chiusura (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
E
F
H
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 -
Piano di monitoraggio -
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 -
Analisi Statistica -
Piano di analisi statistica (SAP) -
Status of the sponsor -
Study -
Study Report -
Study’s Training -
Subject -
Subjects incapable of giving consent personally -
Summary of Product Characteristics (SmPC)