Release of Data from EORTC Studies for Use in External Research Projects

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Release of Data from EORTC Studies

for Use in External Research Projects

POL008 Version 2.03

ALWAYS REFER TO THE EORTC INTERNET WEBSITE TO CHECK THE VALIDITY OF THIS DOCUMENT

Author:

Associate Head of Statistics Department

Laurence Collette

Signature: Date:

Authorized by:

Director General on behalf of the Board

Françoise Meunier

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1 PURPOSE

To define 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.

This procedure applies whenever individual patient data is released by the EORTC Headquarters to

researchers not employed by EORTC Headquarters (with the exception of routine transfers of safety data for regulatory authorities; contractual data transfers to third parties and transfers of data from a site or

collaborative group back to themselves upon their request*) The procedure thus applies whenever

an external academic researcher requests individual patient clinical data from EORTC studies, for which the primary results were already published, for their own research

individual patient clinical data of (published or unpublished but then subject to EORTC Policy 009) EORTC studies are released for the purpose of statistical analyses correlating the translational research findings (using patient biological material or other) with patient clinical data (usually outcome data) that are conducted outside the EORTC Headquarters. This applies irrespective of whether the projects are specified in the EORTC study protocol or not

Only requests for data existing in the EORTC central clinical database are covered by this document. Requests for further data collection and transfer of data from the EORTC Virtual Tumor Bank are not covered.

* the case of an EORTC investigator (resp. collaborating group in an intergroup trial) asking to receive a copy of the data of the patient from his/her own institution (resp. group) entered in an EORTC study (resp. intergroup study coordinated by EORTC) needs no specific approval.

2 DEFINITIONS

Requestor: the person seeking access to data from EORTC study(s) for the purpose of carrying out an external research project. This person is also the scientific leader of that research project.

External research project (ERP): an academic research project that intends to use data from all or a subset of patients from one or several EORTC studies

External Research Project Coordinator: the EORTC staff member responsible for reviewing, approving and following up the external research project

External Research Project Secretary: the EORTC staff member who is responsible for the filing of the External Research Projects documentation

EORTC endorsed translational research project: translational research project involving patient biological material or other from an EORTC study that was approved by one of the official EORTC bodies (EORTC Protocol Review Committee, EORTC Board, EORTC Translational Research Advisory

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3 POLICY

Our policy builds on the central principles of the Organization for Economic Co-operation and Development (OECD) in its report "OECD Principles and Guidelines for Access to Research Data from Public Funding". Recognizing that access to international data helps produce a better understanding of public health issues and worldwide disease prevention and control, the EORTC makes data from its clinical studies available to other academic researchers. Considering that on-going research contributing to the completion of datasets must not be compromised by premature or opportunistic sharing and analysis of data, the EORTC will not release the data of its study until the primary study results have been published.

An investigator who wishes to use data from one or more EORTC studies must make a formal request which is reviewed by the EORTC Coordinator for External Research Project. Specifically the scientific merit and feasibility of each request will be evaluated. Requests will only be considered once the primary study analyses have been published. Any release of data will take into consideration individual patients’ rights to privacy.

4 HOW TO REQUEST EORTC DATA

4.1 Submission of an ERP by a requestor

To submit a request for using EORTC data, the requestor fills out the EORTC data request form that is accessible on the EORTC website.

The EORTC Coordinator will first check the completeness of the form and may ask the requestor further specifications on the research project via e-mail.

4.2 Review and approval of the ERP request

4.2.1 Projects that do not involve biological material of patients from EORTC

studies and that are not an intrinsic part of an EORTC study protocol (non

"EORTC endorsed projects")

For such projects, once the data request form is complete, the document is sent for approval to the

Chairperson of the relevant EORTC groups and to the Study Coordinator of the individual EORTC studies involved. The EORTC Statistician in charge of the concerned EORTC groups is informed. The Chairperson of the EORTC Group that conducted the EORTC studies involved in the ERP reviews the scientific value and feasibility of the ERP and sends his/her comments or approval by e-mail addressed to the [email protected]. Likewise, when contacted, the Study Coordinator(s) of the studies involved in the ERP sends his/her

comments, if any or approval by e-mail to [email protected]

Once all involved parties have confirmed their approval of the project, and once the EORTC Headquarters team, through the Statistician, has confirmed the feasibility of the project, the ERP Coordinator officially approves the project. The ERP Secretary informs the requestor and relevant EORTC Headquarters

Statistician that the project is approved and that the data release is authorized. The EORTC Statistician will then proceed to the transfer of the selected data to the requestor.

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EORTC studies, that are not part of the predefined study objectives stated

in the protocol ("EORTC endorsed projects" not specified as objectives of

the protocol)

Such projects must be endorsed by the EORTC: they must either be approved by the EORTC Board through competitive EORTC processes (Strategy Meeting application calls, EORTC Group Annual Meeting (EGAM) application calls..) or approved by the EORTC Translation Research Advisory Committee (TRAC) in the case of spontaneous application for access to human biological materials (see POL014) Therefore, a simplified approval process applies since only the feasibility and timelines of the data transfer needs to be validated at this stage.

Once the data request form is complete, the document is sent for notification to the Translational Research Team who will confirm that the scientific project was indeed endorsed by the EORTC. The EORTC Statistician in charge of the concerned EORTC groups is informed and asked to verify that the database is accessible. Once confirmation is obtained from the EORTC Translational Research Team and EORTC Statistician, the ERP Coordinator officially approves the project. The ERP Secretary informs the requestor and relevant EORTC Statistician that the project is approved and that the data release is authorized. The EORTC Statistician will then proceed to the transfer of the database to the requestor.

4.2.3 Projects involving data from EORTC patients, that are part of the objectives

specified in the EORTC protocol

Such projects were endorsed by EORTC during the approval of the protocol by the Protocol Review Committee. The request for release of data is required when the data analyses are conducted outside of the EORTC Headquarters. Therefore a simplified approval process applies since only the feasibility and timelines of the data transfer need to be validated at this stage.

Once the data request form is complete, the document is sent to the EORTC Statistician in charge of the concerned EORTC groups to verify that the database is accessible. Once confirmation is obtained from the EORTC Statistician, the ERP Coordinator officially approves the project. The ERP Secretary informs the requestor and the EORTC Statistician that the project is approved and that the data release is authorized. The EORTC Statistician will then proceed to the transfer of the database to the requestor.

4.3 Data Transfer

The data will be preferentially transferred in the form of an ASCII file (with .dat extension), with associated SAS® programs to load the data into SAS. In case data from several studies are requested, one such set of files will be provided for each study. If another file format is needed or if specific recoding of (a subset of) variables is needed, this should be clearly indicated in the ERP application form and consideration will be given to providing the files in the desired format, whenever technically feasible for the EORTC.

If necessary, the EORTC may provide one and only one update of the database during the course of the ERP.

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On a yearly basis, the Requestor (or his/her designee) will inform the EORTC of the progress of the ERP and will update the anticipated timelines whenever required, by e-mail sent to [email protected]. The update is expected at latest on the anniversary date of the ERP approval. The Requestor will in particular inform the ERP of any publication resulting from the ERP (presentation at scientific congresses, abstracts, full-length articles).

In case the Requestor delegates the follow-up of the ERP to one of his/her collaborators, the name and e-mail address of that person must be indicated on the ERP request form.

5 TERMS AND CONDITIONS

By completing and submitting the ERP request form, the Requestor and his team agree with the present EORTC Policy and accept the responsibilities and conditions set by the present policy and summarized below.

FAILURE TO COMPLY WITH THOSE TERMS, IN PARTICULAR, PUBLICATION OF RESULTS IN ANY FORM

WITHOUT PRIOR APPROVAL BY THE EORTC WILL BE CONSIDERED A BREACH OF POLICY AND WILL BE

REPORTED TO THE EORTCEXECUTIVE COMMITTEE FOR AUDIT AND EVALUATION.

5.1 Publication of ERP results, authorship, acknowledgement to EORTC

The publication of ERPs for projects that are an integral part of the objectives of an EORTC study protocol should be conform with the publication policy specified in the protocol, with the EORTC Group specific publication policy and with the EORTC Publication Policy (EORTC Policy 009) regarding authorship rules and review process.

The following acknowledgement to EORTC will appear in the publication of other types of ERPs: “The authors thank the European Organization for Research and Treatment of Cancer for permission to use the data from EORTC studies [list of study numbers] for this research. The contents of this publication and methods used are solely the responsibility of the authors and do not necessarily represent the official views of the EORTC Headquarters.”

Inclusion of EORTC representative(s) (from the group or from the Headquarters) as co-author will be considered for each ERP on a case by case basis. If such an authorship is considered, it will be prospectively mentioned in the ERP request form.

In case full-length articles are prepared, the Requestor will send the draft version by e-mail to [email protected] at least 15 working days before the submission to a journal, in order for the ERP Coordinator to check the conformity of the publication with the present policy.

In case presentations or abstracts are prepared for submission, these will also be sent to [email protected] within 5 days prior to the submission/presentation.

The Requestor should send a PDF copy of the article to [email protected] within 3 months after publication.

5.2 Confidentiality of data

The EORTC data shared for an ERP are confidential and can only be used for the research described in the approved ERP. The copy of the EORTC data at the Requestor's site must be destroyed after the ERP is completed, except in the case of meta-analyses (for which a permanent meta-analysis database may be maintained and regularly updated).

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5.3 Responsibilities of the Requestor

The Requestor takes full responsibility for

Submitting the ERP request for data to the EORTC ERP Coordinator by completing the electronic ERP request form

Completing the ERP in compliance with the present procedure

Informing the ERP Secretary of the progress of the ERP on a yearly basis, with documentation of any publication (abstract, articles). The update is expected at the latest on the anniversary date of the ERP approval.

Submitting the draft version of eventual full-length publications to the ERP Secretary at least 10 working days before the effective submission and of abstracts at least 5 working before the submission

Ensuring the confidentiality of the EORTC data

Destroying the local copy of the EORTC data at completion of the ERP, unless the ERP is a meta-analysis, in which case EORTC may agree not to request data base destruction.

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6 REFERENCES

OECD Principles and Guidelines for Access to Research Data from Public Funding; http://www.oecd.org/dataoecd/9/61/38500813.pdf (last accessed August 22. 2008)

7 DOCUMENT HISTORY

Version number Brief description of change Author Issue date

1.0 Initial Release Laurence Collette October 2001

1.1

Changed MA into CP.

Clarified responsibilities in first paragraph of 4.2.2. Added references to WP6301.

Added exception to database destruction in case of Meta-analysis.

Added acknowledgement to EORTC and disclaimer

Laurence Collette 02/06/2004

2.0

Changed to new template, cleared the document of procedural aspects internal to the EORTC

Headquarters (now covered by ST-008-SOP), implemented web-based submission of projects

Version number Brief description of change Author Effective date

2.1

Included release of data involving biological material and simplified process for projects endorsed by EORTC. Added the statement

regarding "breach of policy". Clarified requirements for submission of publications (incl. Abstracts)

2.2

Expanded the scope of chapter 4.2.3 to all projects that are part of the objectives of a protocol, irrespective if they involve or not biological material from the patients.

2.03

Clarified introduction section. Replace Translational Research Unit by Translational Research Team. Increased time for review of full papers from 10 to 15 days.

Release of Data from EORTC Studies for Use in External Research Projects