Medical or public health measure taken whose purpose is to prevent, rather than treat or cure a disease. Primary prophylaxis is generally intended to prevent the development of a disease, while secondary prophylaxis is intended to prevent the disease, once …
The anticipated start date for the recruitment of subjects (patients) for a Clinical Trial. Source: EU Clinical Trials Register
An individual, company, institution, or organisation authorised to act on behalf of the sponsor of a clinical trial. Must be based in the EU or the EEA, which includes Iceland, Norway, and Liechtenstein. Source: EU Clinical Trials Register
A description of the main objectives of the trial. Source: EU Clinical Trials Register
The approval granted by the Regulatory Authority to market a specific product in a particular country. Source: EU Clinical Trials Register
MedDRA (Medical Dictionary for Regulatory Activities) – is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Source: EU Clinical Trials Register
Key to MedDRA hierarchical levels (highest to lowest) SOC (System Organ Class) HLGT (High Level Group Term) HLT (High Level Term) PT (Preferred Term) LLT (Lowest Level Term). Source: EU Clinical Trials Register
A description of the medical condition being studied in non-medical language. Source: EU Clinical Trials Register
Description of intended indication for the product under development. Source: EU Clinical Trials Register
This is where the trial will be conducted in more than one Member State of the European Economic Area. Source: EU Clinical Trials Register