Utility of ctDNA to support patient selection for early phase clinical trials: The TARGET Study

CRUK Clinical and Experimental Pharmacology Group (CEP) EGA Policy for The TARGET Study.

CR-UK Manchester Institute Clinical and Experimental Pharmacology Group DATA ACCESS AGREEMENT This agreement governs the terms on which access will be granted to the genomic data generated by the Clinical and Experimental Pharmacology Laboratory, CR-UK Manchester Institute. In signing this agreement, You are agreeing to be bound by the terms and conditions of access set out in this agreement. For the sake of clarity, the terms of access set out in this agreement apply both to the User and the User’s Institution (as defined below). User Institution and User are referred to within the agreement as “You” and “Your” shall be construed accordingly. Definitions: CEP means the Clinical and Experimental Pharmacology Laboratory, a CR-UK funded laboratory within the CR-UK Manchester Institute. Data means all and any human genetic data obtained from CEP. Data Subject means a person, who has been informed of the purpose for which the Data is held and has given his/her informed consent thereto. User means a researcher whose User Institution has previously completed this Data Access Agreement and has received acknowledgement of its acceptance. Publications means, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research. User Institution means the organisation at which the User is employed, affiliated or enrolled. Terms and Conditions: In signing this Agreement: 1. You agree to use the Data only for the advancement of medical research, according to the consent obtained from sample donors. 2. You agree not to use the data or any part thereof for the creation of products for sale or for any commercial purpose. 3. You agree to preserve, at all times, the confidentiality of information and Data pertaining to Data Subjects. In particular, You undertake not to use, or attempt to use the Data to compromise or otherwise infringe the confidentiality of information on Data Subjects and their right to privacy. 4. You agree not to attempt to link the data provided under this agreement to other information or archive data available for the data sets provided, even if access to that data has been formally granted to you, or it is freely available without restriction, without specific permission being sought from the relevant access committees. 5. You agree not to transfer or disclose the Data, in whole or part, or any identifiable material derived from the Data, to others, except as necessary for data/safety monitoring or programme management. Should You wish to share the Data with a collaborator outwith the same Institution, the third party must make a separate application for access to the Data. 6. You agree to use the data for the approved purpose and project described in your application; use of the data for a new purpose or project will require a new application and approval. 7. You accept that Data will be reissued from time to time, with suitable versioning. If the reissue is at the request of sample donors and/or other ethical scrutiny, You will destroy earlier versions of the Data. 8. You agree to abide by the terms outlined in the 'Publications Policy' as set out in Schedule 1. 9. You agree to acknowledge in any work based in whole or part on the Data, the published paper from which the Data derives, the version of the data, and the role of CEP and the relevant primary collectors and their funders. Suitable wording is provided in the Publications Policy given in Schedule 1. 10. You accept that CEP, the original data creators, depositors or copyright holders, or the funders of the Data or any part of the Data supplied: a) bear no legal responsibility for the accuracy or comprehensiveness of the Data; and b) accept no liability for indirect, consequential, or incidental, damages or losses arising from use of the Data, or from the unavailability of, or break in access to, the Data for whatever reason. 11. You understand and acknowledge that the Data is protected by copyright and other intellectual property rights, and that duplication, except as reasonably required to carry out Your research with the Data, or sale of all or part of the Data on any media is not permitted. 12. You recognise that nothing in this agreement shall operate to transfer to the User Institution any intellectual property rights relating to the Data. The User Institution has the right to develop intellectual property based on comparisons with their own data. 13. You accept that this agreement will terminate immediately upon any breach of this agreement by You and You will be required to destroy any Data held. 14. You accept that it may be necessary for CEP or its appointed agent to alter the terms of this agreement from time to time in order to address new concerns. In this event, CEP or its appointed agent will contact You to inform You of any changes and You agree that Your continued use of the Data shall be dependent on the parties entering into a new version of the Agreement. 15. You agree that you will submit a report to the Data Access Committee, if requested, on completion of the agreed purpose. The Data Access Committee agrees to treat the report and all information, data, results, and conclusions contained within such report as confidential information belonging to the User Institution. 16. You accept that the Data is protected by and subject to international laws, including but not limited to the UK Data Protection Act 1998, and that You are responsible for ensuring compliance with any such applicable law. The Data Access Committee reserves the right to request and inspect data security and management documentation to ensure the adequacy of data protection measures in countries that have no national laws comparable to that which pertain in the EAA. 17. This agreement shall be construed, interpreted and governed by the laws of England and Wales and shall be subject to the non-exclusive jurisdiction of the English courts. SCHEDULE 1 Publications Policy The primary aim of CEP is to gain a greater understanding of the fundamental basis of how cancer develops and apply that knowledge to develop new diagnostic tests, potential treatments and better ways to predict the outcomes. Authors who use data from the project must acknowledge CEP using the following wording "This study makes use of data generated by Clinical and Experimental Pharmacology Group, CR-UK Manchester Institute (http://www.cruk.manchester.ac.uk). Funding for the project was provided by core funding to CRUK Manchester Institute (C5759/A27412), the Manchester CRUK Centre Award (C5759/A25254) and via the CRUK Manchester Experimental Cancer Medicines Centre (A20465)" and cite the relevant primary publication. Users should note that CEP bears no responsibility for the further analysis or interpretation of these data, over and above that published by CEP.