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Good clinical practice
This Directive establishes the basic principles framing the conduct of clinical trials on medicinal products. Its aim is to ensure the quality of clinic trials by respecting human rights and human dignity.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. [See amending acts].
This Directive concerns clinical trials of medicinal products including multi-centre trials.
This Directive does not apply to non-interventional clinical trials.
Protection of clinical trial subjects
The trial subjects are protected. On the one hand, a clinical trial may only be undertaken if the risks to the subject are not disproportionate to the potential benefits of the medical research. On the other hand, the right of the subject to physical and mental integrity must be respected, as well as the right to privacy.
The medical care given to the subjects and medical decisions made on their behalf are the responsibility of an appropriately qualified physician.
Trial subjects are to be provided with a contact point, where further information can be obtained.
Role of the Ethics Committee
In preparing its opinion on clinical trials, the Ethics Committee must take into consideration a certain number of elements, in particular:
- the relevance of the trial and the trial design;
- the protocol;
- the suitability of the investigator (i.e. the person responsible for performing the clinical trials on a site) and his supporting staff;
- the quality of the facilities.
The Ethics Committee’s opinion must be delivered before the start of the clinical trials.
Member States must establish a procedure by which a single Ethics Committee opinion must be delivered for each Member State, including the case of multi-centre clinical trials.
Conduct of a clinical trial
The Directive describes the conditions and time limits to be respected in order to begin a clinical trial.
The sponsor (i.e. the person, firm, institution or body responsible for mounting, managing and/or funding the clinical trial) must, within 90 days of completion of the clinical trial, duly inform the Member States.
Member States on whose territory the clinical trial is performed must enter data extracted from the initial request, amendments as appropriate and the notification at the end of the clinical trial, into a database.
The European Medicines Evaluation Agency can, by derogation, make part of the information entered in this database available to the public.
A Member State must immediately inform the other Member States and the Commission whenever:
- it suspends or prohibits the trial because the conditions set out in the application cease to be met or because doubts arise as to the safety or scientific justification of the trial;
- it is of the opinion that the sponsor or investigator is no longer fulfilling his obligations.
Manufacture and import of investigational medicinal products
The manufacture and import of investigational medicinal products is subject to the authorisation referred to Directive 2001/20/EC.
The particulars to appear on the outer packaging or, where there is no outer packaging, on the immediate packaging of investigational medicinal products, must be published by the Commission in the good manufacturing practice guideline on investigational medicinal products to be adopted.
Compliance with good clinical practice
The Member States must appoint Community inspectors. These inspectors carry out inspections on behalf of the Community at relevant sites, notably trial sites and manufacturing sites, in order to check compliance with the provisions of good clinical practice. An inspection report must be prepared.
The European Medicines Evaluation Agency is responsible for coordinating inspections.
Inspections may be carried out in a third country, where there are agreements between the Community and the third country.
Notification of adverse events
The investigator must immediately report all serious adverse events to the sponsor, except for those listed in the protocol or in the investigator’s brochure as not requiring immediate reporting.
Adverse events and abnormalities identified in the protocol as critical to safety evaluations must be reported to the ethics committee and the sponsor. In the event of the death of a participant in a clinical trial, the investigator must supply the sponsor and the ethics committee with any additional requested information.
- must ensure that all the relevant information about adverse events are reported to the Member State concerned within the time limits;
- must maintain detailed records of all suspected adverse events, which must be submitted to the Member States in whose territory the clinical trial is being conducted.
In the event of suspected serious unexpected adverse reactions to an investigational medicinal product occurring on its territory, the Member State must ensure that this event is reported to the European Medicines Evaluation Agency, which must inform the competent authorities of the other Member States.
The Directive is without prejudice to the general civil and criminal liability of the sponsor or the investigator.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
OJ L 121 of 1.5.2001
|Amending act(s)||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Regulation (EC) No 1901/2006||
OJ L 378 of 27.12.2006
|Regulation (EC) No 596/2009||
OJ L 188 of 18.7.2009