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	The EORTC name may be used only with the approval of the EORTC Executive Committee via the Director General. The document describes i.e. the applications, the EORTC support and the contractual obligations of the applicant / organizer	July. 2010	POL006
Scientific Audit Committee	It describes the responsibilities of the Scientific Audit Committee (SAC) and the process of EORTC group review.	Sep. 2006	POL007
Release of data from EORTC studies for use in External Research Projects	It defines the terms and conditions under which individual data from all or a subset of the patients treated within EORTC protocols may be released to academic institutions for the purpose of scientific research projects	March 2009	POL008
Disclosure of Results and Publication Policy	It describes the EORTC policy regarding the primary trial publication in respect to the timing of the release of results and publication in a peer-reviewed journal, the authorship rules, the rules for acknowledging contributors to the study and sources of funding and the review process within the EORTC Headquarters	March 2009	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)	Describes the role and missions of the TRAC	May 2010	POL014
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
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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