A sub-study, or ancillary study, is a study performed on a sub group of the subjects included in the clinical trial. For example, a pharmacokinetics or pharmacogenetics sub-study may include a sample of the patients participating in the clinical trial. …
The clinical trial using placebo – A dummy medicine containing no active ingredients; an inert treatment; Source: EU Clinical Trials Register
A study is part of a Paediatric Investigation Plan. Source: EU Clinical Trials Register
ClinicalTrials.gov registry number. NCT numbers are 8 digits, ascending and correlated with registration date. Source: EU Clinical Trials Register
World Health Organisation Universal Trial Number. The UTN is a number, obtained by the trial’s sponsor or principal investigator and is used for the identification of clinical trials worldwide. Source: EU Clinical Trials Register
Clinical trial includes female subjects who have the potential to give birth and are not using contraception. Source: EU Clinical Trials Register
Clinical trial includes female subjects who have the potential to give birth and are using contraception. Source: EU Clinical Trials Register
During the study it is necessary to provide all clinical centers with the Investigational Product (IP), refill the stocks (if necessary), properly manage the IP in each centers (IP accountability) and retrieve IP before its expiring or at the end …
Amendments are changes to the study protocol (and any other applicable study-related documents). They can be substantial or not substantial. – Substantial amendments must be submitted to the involved Ethic Commettees (ECs) and Competent Authorities (CAs), if applicable.The Sponsor must …
Before a study starts, it is necessary to get all mandatory approvals. The required documents may vary from Country to Country and from an Ethics Committee (EC) to another. Application for a Clinical Research to EC before a study starts, …