DATA PRESERVATION AND SHARING INITIATIVE. 1. Aims of the EORTC QLG Data Repository project
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1 DATA PRESERVATION AND SHARING INITIATIVE 1. Aims of the EORTC QLG Data Repository project The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group Data Repository project aims to 1) create a central dataset for storage of all field studies data, and 2) establish guidelines to be used to harmonize the way field studies are conducted and the way data for field studies are collected. 2. Definitions Data Repository: a place where data from field studies are stored and maintained over time. In order to create such a repository it is necessary to collect all the available information that concerns the different steps of a field study and to create a central dataset where all the data used for field testing will be stored. EORTC Quality of Life Department (QLD): a department within the EORTC, whose objectives are to evaluate the importance of various factors that improve the Quality of Life (QoL) of cancer patients, to supervise the evaluation of QoL in selected cancer clinical trials and to encourage physicians to pay greater attention to QoL factors in the treatment of cancer. EORTC Quality of Life Group (QLG): a group within the EORTC, whose mission is to develop measures of patient-reported outcomes in cancer, including health-related QoL, and to promote and coordinate studies concerning the QoL of cancer patients. Principal Investigator (PI) or data sharer: the scientific leader of the original research project (field study) that was funded by an EORTC QLG grant and that yielded data that should be stored and preserved in the Data Repository. New Investigator: the scientific leader of a new research project to be carried out on data already in the Data Repository.
2 3. Aims of the EORTC QLG data preservation and sharing initiative for field studies EORTC QLG funded research produces different datasets, usually stored and kept by the PIs in different institutions. Making this information available centrally to the EORTC QLG will allow safe and efficient data preservation and possible data use for future cancer research. The aims of our data preservation and data sharing initiative are - to identify and develop generic standards for data collection in order to keep the field study process harmonized - to promote good data preservation strategies - to promote the sharing of data for collaborative, high-quality and ethical new research. 4. EORTC QLG policy on data preservation and sharing for field studies Our data preservation and sharing policy applies to all EORTC QLG funded field studies Funding request When applying for funding for a new study, the PI should include in his proposal a section concerning the data preservation and sharing strategy. The contract with the host institution will include a clause for data sharing. When applying to the Research Ethics Committee for the study, the data sharing information should be included and approval sought. The QLG Executive Committee (EC) should be informed about the submission process Data storage Data will be stored on the EORTC server, in a folder with restricted access. Only the person in charge of the Data Repository project and the head of the EORTC QLD will have access to this folder Data sharing
3 The EORTC QLG expects data to be available in a reasonable time and manner after completion of data collection. PIs are asked to provide a copy of the final locked dataset. Data sharers should ensure data quality. Shared data should be anonymized, where anonymized data are defined as data from which the participant cannot be identified by the recipient of the information Data transfer Two options are available for data transfer. The anonymized data could be sent by in a password protected compressed folder or, as an alternative, an existing secured EORTC website could be used. Phase IV grantees who wish to use this second option will be provided with further details by the person in charge of the Data Repository project. Two options are also available for sending the password. The password could be sent in a separate or it could be provided by telephone Future use of the Data Repository A defined period of exclusive use of the data by the PI for primary research will be established: data should become available as from the moment the phase IV paper has been published, unless the PI of the original research makes a specific request for a longer period and the QLG EC agrees. Sharing should enhance the long-term value of the data, and ongoing research should not be compromised by premature data sharing. After this period the Data Repository will be available to EORTC QLG active members for use in future new studies. PIs who are not currently EORTC QLG active members but who have contributed to the Data Repository with data from their field studies will also have the opportunity to request data from the Data Repository Possible new studies derived from shared data Possible new studies derived from shared data should be subject to approval and provide added value to existing research and meet quality standards and ethical requirements. Applicants should write an application in the form of a short study protocol. The new study will need to be approved by the QLG EC. If the new study is approved, the QLG EC will inform the PI of the original research. The PI will have
4 the opportunity to give comments and ask for amendments, but it will not be possible for him/her to reject the study proposal because, as specified in the contract template, intellectual property is with the QLG. Collaboration between the data sharer (PI of the original research), the funder (EORTC QLG) and the New Investigator is not mandatory. However, in the interests of research, such collaboration is proposed and encouraged. The PIs will be asked whether they would be interested in contributing to the new study (see publication policy). In cases where the applicant and the PI of the original research are the same person no specific approval from the QLG EC is needed. For possible new research the appropriate regulatory permissions should be obtained. 5. Publication policy In the case of new studies based on shared data, the publication policy for new studies should be part of the submitted research proposal. PIs of the original research will be asked whether they would be interested in contributing to the new study. As such, PIs will have the option of being a co-author if their contribution meets the accepted criteria for authorship. A predefined acknowledgement of the PI will appear in the publication otherwise. The publication must acknowledge the source of the data as belonging to the EORTC QLG Data Repository. 6. Confidentiality of data Shared data in the Data Repository are confidential and will not be released by the funders to third parties. 7. References - EORTC data release policy ( - MRC data access principles (
5 - MRC data sharing initiative ( ndex.htm) - MRC personal information in medical research ( - OECD principles and guidelines for access to research data from public funding (
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