Policies

Signed documents are available upon request.

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.

Protection of Human Subjects Participating in Clinical and Translational Research
It provides guidance on how to ensure the protection of the rights, safety and well-being of trial subjects pertaining to all EORTC activities within the European framework. This policy also ensures homogeneous conduct of studies involving biological material from patients who have participated in EORTC clinical trials.

Research Misconduct
It describes the review of research misconduct allegation and the subsequent investigation and outcome.

Independent Data Monitoring Committees for EORTC studies
It describes the use of Independent Data Monitoring Committees in EORTC clinical trials.
IDMC charter

Intergroup Studies
It outlines the EORTC policy on intergroup studies in order to facilitate this type of collaboration.

Criteria and guidelines for giving the EORTC label to scientific meetings
Its describes what is an EORTC labeled meeting and conditions to use the EORTC logo.

Scientific Audit Committee
It describes the responsibilities of the Scientific Audit Committee (SAC) and the process of EORTC group review.

Data Sharing
It defines the terms and conditions under which electronic records of individual data from all or from subsets of the patients from EORTC studies may be shared with other organizations or individual researchers for the purpose of scientific research projects or may be posted on data repositories.

Disclosure of Results and Publication Policy
Policy regarding study publication (incl. timing; authorship and acknowledgement rules; review process; conditions of publication of safety, TR of ancillary studies rel to the protocol and their authorization process; research results from the use of biological material from clinical studies).

New Drug Advisory Committee (NDAC)
Describes the missions and tasks of this committee which supports and gives recommendations to the clinical research groups in new drug development within the EORTC network. It describes also the interaction between NDAC and the EORTC Headquarters Early Project Optimization Department.

Translational Research Advisory Committee (TRAC)
It outlines the missions and tasks of the Translational Research Advisory Committee and the interaction with the translational research team at the EORTC Headquarters.

Protocol Development Process, Selection and Approval Procedures for EORTC Studies
It describes the protocol development process and the selection and approval procedures for EORTC studies, focuses on the role of the different EORTC committees in the study selection and development, on the criteria used at different milestones, and on the process for submitting study proposals to EORTC and developing them into full protocols.

EORTC principles for investigational sites activation
Describes the principles for investigational site participation to EORTC studies.

Human Biological Material Collection, Storage and Use
It defines the position of the EORTC concerning the management of HBM collected from participants enrolled in EORTC studies and projects with regards to collection storage and use. It outlines the minimal principles for both EORTC and non-EORTC parties.

Developing EORTC Guidelines, Expert Opinions, and the use of EORTC Results in Promotional Material on Cancer Care
EORTC as a clinical research organisation needs to create a structure for the development and approval of documents that are published as recommendations. These documents are encouraged, as they will increase the EORTC’s visibility and quality of cancer care and should be published in a peer reviewed journal. The forms of these recommendations need to comply with international references for level of evidence and be in compliance with EORTC missions. This policy does not apply to individual studies but to the recommendations dedicated to a specific clinical or methodological situation.

Protection of Personal data
It aims to ensure adequate protection of personal data collected, stored or processed or otherwise handled by EORTC staff, its members, experts or any other third party handling personal data on behalf of EORTC.
Objectives of this policy are to ensure a clear understanding of the EORTC strategy to achieve these aims by all concerned persons.

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