EORTC Policies

EORTC Policies and Legal Aspects

Policy	Contents	Last update	Load pdf file
Conflict of Interest - Confidentiality	Define areas of conflict of interest and identifies when disclosure should be provided (to eventually place limitations on investigators' participation in EORTC activities.	Oct. 2006	POL001
Protection of human subjects participating in medical research	Ensures the respect of the rights and the integrity of human subjects participating in EORTC trials	Sept. 2006	POL002
Trial Misconduct and Fraud	Minimize the effects of clinical trial fraud and misconduct and if possible prevent them from occurring.	Sep. 2003	POL003
Independant Data Monitoring Committee and Interim Analyses	Describes the EORTC policy for the use of IDMC in randomized phase II and randomized phase III clinical trials	Feb. 2004	POL004
Intergroup trials involving non-EORTC group	Outlines the EORTC policy on intergroup trials in order to facilitate intergroup collaboration	Feb. 2005	POL005
Criteria and guidelines for giving the EORTC label to scientific meetings		Nov. 2005	POL006
Scientific Audit Committee		Sep. 2006	POL007
Release of data from EORTC studies to the outside	It defines terms and conditions under which individual patient data from all or a subset of the patients treated with EORTC protocols may be released to an outside researcher, whether an EORTC investigator or not	Jun. 2004	POL008
Publication Policy	The following text does not attempt to define a general EORTC publication policy but mainly addresses specific problems or situations. It proposes a clear statement with regards to the acknowledgement of trial participants and company participation	Sep. 2006	POL009
Accrual accounting in Intergroup Trials	Describing how patient accrual within Intergroup trials involving an EORTC clinical group will be counted for EORTC membership	Feb. 2005	POL010
EORTC Support to Intergroup Trials	It concerns only trials that are not conducted by the industry and describes the framework of the EORTC support to Intergroup trials	Feb. 2005	POL012
New Drug Advisory Committee (NDAC)	Committee which supports and gives recommendations to the clinical research groups in new drug development within the EORTC Network	Feb. 2005	POLO13
Translational Research Advisory Committee (TRAC)	Committee which supports and provides expert advice on all TR projects	Feb. 2005	POL014
EORTC Tissue Research Policy	Outlines the general principles of EORTC Tissue research, aims of the EORTC Tumor Bank to support histology review and translational research, and rules on material use for histology review and translational research.	Jul. 2003	POL015
EORTC protocol submission, selection and development procedures	Describes the procedure implemented by the EORTC Board to select studies that will be supported by EORTC.	Nov. 2005	POL016
Histology review process and/or biological material collection within EORTC clinical trial(s)	Describes the functioning and workflow of histology review and/or biological material collection within the scope of an EORTC clinical trial.	May 2005	POL017
EORTC principles for investigational sites activation	Describes the principles for investigational site participation to EORTC studies.	March 2007	POL018
EORTC Guidelines on Cancer Care	EORTC Policy for Producing EORTC Guidelines/Expert Opinions/Promotional Material on Cancer Care.	June 2008	POL019

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Legal Aspects

The EORTC is an international association under Belgian law. All trials carried out under the auspices of the EORTC are, by definition, the responsibility of the EORTC. The registered office of the EORTC is at 83, Av. E. Mounier, B-1200 Brussels, Belgium.
The EORTC insurance program established in 1993 covers all patients entered in EORTC studies (except patients from the US, Canada and Australia) and for which the EORTC is the sponsor/promotor. For studies conducted in collaboration with the pharmaceutical industry, insurance coverage must be discussed on a case-by-case basis.
In order to fulfill regulatory affairs obligations and to guarantee adequate trial insurance coverage for patients and investigators, according to their national law, the Regulatory Affairs Unit at the EORTC Headquarters must give its permission for each center prior to patient recruitment.
On the other hand, the EORTC plays a major role both at European and national levels to alert regulators on the needs for independence clinical research conducted without commercial aims.

Ethical Aspects and Informed Consent/Insurance

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 committee must be obtained before an institution is given the authorization to register or randomize a patient in 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 people involved in clinical activities needs to comply with EORTC policies and procedures. More specifically investigators, Board members must sign a conflict of interest statement.

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