Newsletters are informative emails sent periodically to the study sites to update them on the progress of the study. Newsletters can be sent weekly, monthly, or whenever is it considered appropriate and are prepared by the CRO, the Sponsor or …
The patient fee is the payment the site receives for each enrolled patient. The fee covers all the site’s expenses for the conduct of the study, from the time spent to the materials used. The patient fee is reported in …
The synopsis is a summary of the main points of the protocol, usually needed to present the aim of the study before the developing of the full protocol. Once the study is defined and the protocol drafted, the final synopsis …
A person participating in a trial – the subject may be a patient or a healthy volunteer. Source: EU Clinical Trials Register
Subjects who are incapable of giving consent personally to be enrolled in the trial. For example: minors or mentally impaired subjects. Source: EU Clinical Trials Register
This is the product information document which is made available to all prescribing physicians in the EU for marketed products. Source: EU Clinical Trials Register
A product that contains or consists of engineered cells or tissues, is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue. Source: EU Clinical …
Title of the clinical trial in non-technical terms, suitable for comprehension by individuals without medical/pharmaceutical training. Source: EU Clinical Trials Register
Name of the MA holder of the actual IMP used in the member state concerned by the application. Source: EU Clinical Trials Register
Trial being conducted outside the European Economic Area. Source: EU Clinical Trials Register