Legal aspects

The European Organisation for Research and Treatment of Cancer (EORTC) is an International non-profit association (AISBL) established under the laws of Belgium.

The registered office of the EORTC is 83 Av. E. Mounier, B-1200 Brussels, Belgium.

VAT N° 408292992

The Association is governed by the Belgian law of 27 June 1921 regarding non-profit associations, international non-profit associations and foundations, and its subsequent amendments.

Statutes

The official Dutch and French versions of the EORTC statues, as recorded in the Le Moniteur belge / Het Belgisch Staatsblad, are available for download. For your convenience, an unofficial English version is also available.

Trial sponsorship

The EORTC is the legal sponsor for the majority of the trials run under its auspices, except in the United States, Canada, and Australia, where trials are performed in collaboration with other partners.

The EORTC insurance program, established in 1993, covers all patients entered into EORTC studies and for which the EORTC is the sponsor/ promoter on the European continent.

For Intergroup trials lead by non-EORTC groups, sponsorship issue is discussed on a case by case basis taking into account applicable legislation. For trials fully supported by an industrial partner, the industrial partner is usually the sponsor.

In order to fulfill the sponsor’s legal obligations and to guarantee compliance with applicable national laws, the International Regulatory Affairs / Intergroup Office at EORTC Headquarters keeps its legal expertise up to date in more than 30 countries in Europe and other countries.

The EORTC also plays a major role both at the European and national levels to alert regulators to the need for independent clinical research conducted without commercial aims.

Protection of patients

All EORTC protocols are written and conducted in accordance with international standards for ethics: the Declaration of Helsinki, Good Clinical Practice guidelines approved by the International Conference on Harmonization. A standard chapter on Ethical Considerations is included in all EORTC protocols.

In accordance with local, regional, and national requirements, written approval from competent ethics committees must be obtained before an institution is given the authorization to register or randomize a patient into a study. Standard guidelines for obtaining informed consent from patients entered in EORTC protocols have been developed. Investigators must obtain a dated and signed consent form from each patient.

All internal and external staff involved in clinical activities need to comply with EORTC policies and procedures including Investigators, EORTC Board members and EORTC Headquarters Staff must sign a conflict of interest statement.

The EORTC holds a valid federal wide assurance (FWA) for the protection of Human Subjects (FWA00004444) in the United States of America.

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