Contract research organisation [CRO]

Compensation in clinical trials is not always a standard but may be offered to participants according to different models and in line with the respective legislation and regulations.

To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or negative opinion. This is to ascertain that the research is conducted in compliance with European regulations, directives and guidelines defined by the International Conference on Harmonisation. This is an international quality standard that describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and ethics committees.

During clinical development the manufacturing and distribution facilities available may not be suitable for a trial medicine (investigational medicinal product (IMP)), however, IMPs must be manufactured, stored and distributed in accordance with good manufacturing practice guidelines (GMP) to ensure that the IMP can be safely administered to trial participants.

A collaboration of a patient organisation with a pharmaceutical company that resulted in a major revision of the Informed Consent document and of the child and adolescent assent forms.

Al fine di ottenere l'approvazione per uno studio clinico, è necessario presentare una domanda di autorizzazione relativa a uno studio clinico agli enti di regolamentazione e a un Comitato etico di ricerca che revisionano il protocollo e forniscono un'opinione positiva o negativa. Ciò avviene per garantire che la ricerca sia condotta in conformità a regolamenti, direttive e linee guida europee definiti dalla Conferenza internazionale sull'armonizzazione. Questo è uno standard qualitativo internazionale che deve essere applicato in tutti gli stati membri dell'UE e descrive le responsabilità e le aspettative di tutti i partecipanti alla conduzioni di studi clinici, compresi sperimentatori, supervisori, sponsor e comitati etici.