Release of Data from Studies for Use in External Research Projects POL008 Version 2.03 ALWAYS REFER TO THE INTERNET WEBSITE TO CHECK THE VALIDITY OF THIS DOCUMENT Author: Associate Head of Statistics Department Laurence Collette Authorized by: Director General on behalf of the Board Françoise Meunier Signature: Signature: Date: Date:
Table of Contents 1 PURPOSE... 3 2 DEFINITIONS... 3 3 POLICY... 4 4 HOW TO REQUEST DATA... 4 4.1 Submission of an ERP by a requestor... 4 4.2 Review and approval of the ERP request... 4 4.2.1 Projects that do not involve biological material of patients from studies and that are not an intrinsic part of an study protocol (non " endorsed projects")... 4 4.2.2 Projects involving data from analysis or review of biological material of studies, that are not part of the predefined study objectives stated in the protocol (" endorsed projects" not specified as objectives of the protocol)... 5 4.2.3 Projects involving data from patients, that are part of the objectives specified in the protocol... 5 4.3 Data Transfer... 5 4.4 Follow-up of the project... 5 5 TERMS AND CONDITIONS... 6 5.1 Publication of ERP results, authorship, acknowledgement to... 6 5.2 Confidentiality of data... 6 5.3 Responsibilities of the Requestor... 7 6 REFERENCES... 8 7 DOCUMENT HISTORY... 8 POL008 Page 2 of 8 Version N : 2.03
1 PURPOSE To define the terms and conditions under which individual data from all or a subset of the patients treated within 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 Headquarters to researchers not employed by 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 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the primary results were already published, for their own research individual patient clinical data of (published or unpublished but then subject to Policy 009) studies are released for the purpose of statistical analyses correlating the translational research findings (using patient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 Headquarters. This applies irrespective of whether the projects are specified in the study protocol or not Only requests for data existing in the central clinical database are covered by this document. Requests for further data collection and transfer of data from the Virtual Tumor Bank are not covered. * the case of an 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 study (resp. intergroup study coordinated by ) needs no specific approval. 2 DEFINITIONS Requestor: the person seeking access to data from 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 studies External Research Project Coordinator: the staff member responsible for reviewing, approving and following up the external research project External Research Project Secretary: the staff member who is responsible for the filing of the External Research Projects documentation endorsed translational research project: translational research project involving patient biological material or other from an study that was approved by one of the official bodies ( Protocol Review Committee, Board, Translational Research Advisory Committee) POL008 Page 3 of 8 Version N : 2.03
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 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 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 studies must make a formal request which is reviewed by the 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 DATA 4.1 Submission of an ERP by a requestor To submit a request for using data, the requestor fills out the data request form that is accessible on the website. The 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 studies and that are not an intrinsic part of an study protocol (non " endorsed projects") For such projects, once the data request form is complete, the document is sent for approval to the Chairperson of the relevant groups and to the Study Coordinator of the individual studies involved. The Statistician in charge of the concerned groups is informed. The Chairperson of the Group that conducted the 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 ERP@eortc.be. 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 ERP@eortc.be Once all involved parties have confirmed their approval of the project, and once the 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 Headquarters Statistician that the project is approved and that the data release is authorized. The Statistician will then proceed to the transfer of the selected data to the requestor. POL008 Page 4 of 8 Version N : 2.03
4.2.2 Projects involving data from analysis or review of biological material of studies, that are not part of the predefined study objectives stated in the protocol (" endorsed projects" not specified as objectives of the protocol) Such projects must be endorsed by the : they must either be approved by the Board through competitive processes (Strategy Meeting application calls, Group Annual Meeting (EGAM) application calls..) or approved by the 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. The Statistician in charge of the concerned groups is informed and asked to verify that the database is accessible. Once confirmation is obtained from the Translational Research Team and Statistician, the ERP Coordinator officially approves the project. The ERP Secretary informs the requestor and relevant Statistician that the project is approved and that the data release is authorized. The Statistician will then proceed to the transfer of the database to the requestor. 4.2.3 Projects involving data from patients, that are part of the objectives specified in the protocol Such projects were endorsed by 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 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 Statistician in charge of the concerned groups to verify that the database is accessible. Once confirmation is obtained from the Statistician, the ERP Coordinator officially approves the project. The ERP Secretary informs the requestor and the Statistician that the project is approved and that the data release is authorized. The 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. If necessary, the may provide one and only one update of the database during the course of the ERP. 4.4 Follow-up of the project The Requestor specifies in the ERP request form the anticipated timelines of the ERP. POL008 Page 5 of 8 Version N : 2.03
On a yearly basis, the Requestor (or his/her designee) will inform the of the progress of the ERP and will update the anticipated timelines whenever required, by e-mail sent to ERP@eortc.be. 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 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 WILL BE CONSIDERED A BREACH OF POLICY AND WILL BE REPORTED TO THE EXECUTIVE COMMITTEE FOR AUDIT AND EVALUATION. 5.1 Publication of ERP results, authorship, acknowledgement to The publication of ERPs for projects that are an integral part of the objectives of an study protocol should be conform with the publication policy specified in the protocol, with the Group specific publication policy and with the Publication Policy ( Policy 009) regarding authorship rules and review process. The following acknowledgement to 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 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 Headquarters. Inclusion of 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 ERP@eortc.be 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 ERP@eortc.be within 5 days prior to the submission/presentation. The Requestor should send a PDF copy of the article to ERP@eortc.be within 3 months after publication. 5.2 Confidentiality of data The data shared for an ERP are confidential and can only be used for the research described in the approved ERP. The copy of the 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). POL008 Page 6 of 8 Version N : 2.03
5.3 Responsibilities of the Requestor The Requestor takes full responsibility for Submitting the ERP request for data to the 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 data Destroying the local copy of the data at completion of the ERP, unless the ERP is a metaanalysis, in which case may agree not to request data base destruction. POL008 Page 7 of 8 Version N : 2.03
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 2.0 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 and disclaimer Changed to new template, cleared the document of procedural aspects internal to the Headquarters (now covered by ST-008-SOP), implemented web-based submission of projects Laurence Collette 02/06/2004 Laurence Collette 02/03/2009 Version number Brief description of change Author Effective date 2.1 2.2 2.03 Included release of data involving biological material and simplified process for projects endorsed by. Added the statement regarding "breach of policy". Clarified requirements for submission of publications (incl. Abstracts) 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. Clarified introduction section. Replace Translational Research Unit by Translational Research Team. Increased time for review of full papers from 10 to 15 days. Laurence Collette 19/10/2010 Laurence Collette 15/11/2011 Laurence Collette 07/03/2012 POL008 Page 8 of 8 Version N : 2.03