| 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 medical research |
Ensures
the respect of the rights and the integrity of human subjects participating
in EORTC trials |
|
|
| Research Misconduct |
It describes the review of research misconduct allegation and the subsequent investigation and outcome. |
Feb
2011 |
|
| 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 |
|
|
| Intergroup
trials involving non-EORTC group |
Outlines
the EORTC policy on intergroup trials in order to facilitate intergroup
collaboration |
Feb.
2005 |
|
| 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
|
|
|
| Scientific
Audit Committee |
It describes the responsibilities of the Scientific Audit Committee (SAC) and the process of EORTC group review. |
|
|
| 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
|
|
|
Disclosure of Results and Publication Policy
|
Policy regarding study publication (incl. timing; authorship & acknowledgement rules; review process; conditions of publication of safety, TR of ancillary studies rel to the protocol & their authorization process; research results from the use of biological material from clinical studies). |
|
|
| Accrual
accounting in
Intergroup Trials |
Describing
how patient accrual within Intergroup trials involving an EORTC clinical
group will be counted for EORTC membership |
|
|
| 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 |
|
|
| New
Drug Advisory Committee (NDAC) |
Committee
which supports and gives recommendations to the clinical research groups
in new drug development within the EORTC Network |
|
|
| Translational Research
Advisory Committee (TRAC) |
Describes the role and missions of the TRAC |
|
|
| Protocol Development Process, Selection and Approval Procedures for EORTC Studies |
It describes the milestones and criteria to select studies to be conducted by the EORTC and the optimal ways for submitting study proposal to EORTC and developing them into full protocols |
|
|
| EORTC principles for investigational sites activation |
Describes the principles for investigational site participation to EORTC studies. |
April 2011 |
|
| EORTC Guidelines on Cancer Care |
EORTC Policy for Producing EORTC Guidelines/Expert Opinions/Promotional Material on Cancer Care.
|
|
|
| Human Biological Material Collection, Storage and Use |
This policy defines the position of the EORTC with regard to custodianship of the portion of human biological materials (HBM) collected in EORTC clinical studies. It outlines the minimal principles for both EORTC and non-EORTC parties. |
Jan 2011 |
|
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