A measure of whether the medicinal product has its intended effect.
The key standards that people who want to participate in a clinical study must meet or the characteristics that they must have. These include inclusion criteria and exclusion criteria. For example, a study might only accept participants who are above or below certain ages.
Endpoint Adjudication Committees
In clinical studies where endpoints are complex to assess and/or include subjective components or the study cannot be blinded, an Endpoint Adjudication Committee, consisting of clinical experts in a specific clinical area, might be set up to harmonise and standardise endpoint assessment and to determine whether the endpoints meet protocol-specified criteria. In order to allow for an unbiased endpoint assessment the members of such a committee should be blinded to treatment assignment. Endpoint Adjudication Committees are, for example, widely used in the assessment of radiological endpoints.
The act of admitting a participant into a trial. Participants should be enrolled only after study personnel have confirmed that all the eligibility criteria have been met. Formal enrolment must occur before randomised assignment.
Essential Documents (EDs)
The essential documents relating to a clinical trial are those which enable both the conduct of the clinical trial and the quality of the data produced to be evaluated; and show whether the trial is, or has been, conducted in accordance with the applicable regulatory requirements.
EU Clinical Trials Register
The website providing the public with information held in the EU clinical trial database, EudraCT. It provides the public with information on clinical trials which have been authorised in the EEA and also those which are part of a PIP (Paediatric Investigation Plan). It gives users the ability to search for information on any paediatric clinical trial and any adult clinical trial recorded in EudraCT.
EudraVigilance Clinical Trials Module (EVCTM)
Part of the EudraVigilance data processing network and management system to facilitate the electronic reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) as required by Directive 2001/20/EC.
European Commission (EC)
The European Commission is the executive body of the European Union, responsible for proposing legislation, implementing decisions, and day-to-day running of the EU.
European Medicines Agency (EMA)
The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.
European Union Drug Regulating Authorities Clinical Trials (EudraCT)
The European Clinical Trials Database of all clinical trials administered by the European Medicines Agency. It is mandatory for sponsors to post clinical trial summary results in EudraCT following the end of a trial.
Specific criteria which are defined within the study protocol that expressly exclude specific individuals from participating in a study. The reasons for considering exclusion can range from safety issues, potential difficulties in management of particular participants or the need to control variables within the study. Exclusion criteria must always be defended ethically to guard against discrimination.
An agreement between an organisation and relevant external parties for example between an organisation and a research organisation. External agreements may be required to confirm issues such as: indemnity, intellectual property, roles and responsibilities, data protection, confidentiality, financial and termination issues, standards of service and where applicable regulatory obligations.