- Advanced therapy investigational medicinal product
means an investigational medicinal product which is an advanced therapy medicinal product as defined in point (a) of Article 2(1) of Regulation (EC) No 1394/2007 of the European Parliament and of the Council;
- Adverse event
means any untoward medical occurrence in a subject to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment;
- Authorised auxiliary medicinal product
means a medicinal product authorised in accordance with Regulation (EC) No 726/2004, or in any Member State concerned in accordance with Directive 2001/83/EC, irrespective of changes to the labelling of the medicinal product, which is used as an auxiliary medicinal product;
- Authorised investigational medicinal product
means a medicinal product authorised in accordance with Regulation (EC) No 726/2004 or in any Member State concerned in accordance with Directive 2001/83/EC, irrespective of changes to the labelling of the medicinal product, which is used as an investigational medicinal product;
- Auxiliary medicinal product
means a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product;
- Clinical study
means any investigation in relation to humans intended: with the objective of ascertaining the safety and/or efficacy of those medicinal products;
- Clinical study report
means a report on the clinical trial presented in an easily searchable format, prepared in accordance with Annex I, Part I, Module 5 of Directive 2001/83/EC and accompanying an application for marketing authorisation.
- Clinical trial
means a clinical study which fulfils any of the following conditions:
- Early termination of a clinical trial
means the premature end of a clinical trial due to any reason before the conditions specified in the protocol are complied with;
- End of a clinical trial
means the last visit of the last subject, or at a later point in time as defined in the protocol;
- Ethics committee
means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;
- Good clinical practice
means a set of detailed ethical and scientific quality requirements for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials ensuring that the rights, safety and well-being of subjects are protected, and that the data generated in the clinical trial are reliable and robust;
- Incapacitated subject
means a subject who is, for reasons other than the age of legal competence to give informed consent, incapable of giving informed consent according to the law of the Member State concerned;
- Informed consent
means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical trial, after having been informed of all aspects of the clinical trial that are relevant to the subject's decision to participate or, in case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical trial;
- Inspection
means the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the clinical trial site, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect;
- Investigational medicinal product
means a medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial;
- Investigator
means an individual responsible for the conduct of a clinical trial at a clinical trial site;
- Legally designated representative
means a natural or legal person, authority or body which, according to the law of the Member State concerned, is empowered to give informed consent on behalf of a subject who is an incapacitated subject or a minor;
- Low-intervention clinical trial
means a clinical trial which fulfils all of the following conditions:
- Manufacturing
means total and partial manufacture, as well as the various processes of dividing up, packaging and labelling (including blinding);
- Member State concerned
means the Member State where an application for authorisation of a clinical trial or of a substantial modification has been submitted under Chapters II or III of this Regulation respectively;
- Minor
means a subject who is, according to the law of the Member State concerned, under the age of legal competence to give informed consent;
- Non-interventional study
means a clinical study other than a clinical trial;
- Normal clinical practice
means the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder;
- Principal investigator
means an investigator who is the responsible leader of a team of investigators who conduct a clinical trial at a clinical trial site;
- Protocol
means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial.
- Serious adverse event
means any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, is life-threatening, or results in death;
- serious breach
means a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.
- Sponsor
means an individual, company, institution or organisation which takes responsibility for the initiation, for the management and for setting up the financing of the clinical trial;
- Start of a clinical trial
means the first act of recruitment of a potential subject for a specific clinical trial, unless defined differently in the protocol;
- Subject
means an individual who participates in a clinical trial, either as recipient of an investigational medicinal product or as a control;
- Substantial modification
means any change to any aspect of the clinical trial which is made after notification of a decision referred to in Articles 8, 14, 19, 20 or 23 and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial;
- Suspension of a clinical trial
means interruption of the conduct of a clinical trial by a Member State;
- Temporary halt of a clinical trial
means an interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it;
- Unexpected serious adverse reaction
means a serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information;