Any document that supports the reconstruction of the trial must be retained at the end of the study. The Sponsor is responsible for archiving all of these documents which are part of the Trial Master File (whose access is strictly …
The amount of financial resources needed for conducting the trial. It should be large enough to cover the reimbursement of all study procedures and exams, cost of submission to Ethic Committee (EC), insurance, contract with a Contract Research Organization (CRO), …
The Clinical Events Committee (CEC) is an independent committee that is responsible for the adjudication of pre-specified clinical events occurred during a Study. The Principal Investigator or the Sponsor can propose members but these must be totally external and independent …
A document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial. The term protocol refers to the protocol, successive versions of the protocol and protocol amendments. Source: EU Clinical Trials Register
A radioactive pharmaceutical, nuclide, or other chemical used for diagnostic or therapeutic purposes. Source: EU Clinical Trials Register
A trial in which subjects are randomly assigned to one of the treatment arms. Source: EU Clinical Trials Register
A rare disease concerns a restricted number of patients in the general population and shows evidence of gravity (because it is life-threatening, invalidating or serious and chronic). The limit accepted in Europe is 5 people in 10,000 affected by the …
A cell or organism in which genetic recombination has occurred. Source: EU Clinical Trials Register
A route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is brought into contact with the body. Source: EU Clinical Trials Register
Really Simple Syndication. RSS is a family of web feed formats used to publish frequently updated workssuch as blog entries,news headlines, audio, and videoin a standardised format. Source: EU Clinical Trials Register