Genomic characterization of metastatic breast cancers

Genomic characterization of metastatic breast cancers

Data Access Policy Preamble Gustave Roussy set up a Data Access Committee to process requests for access to the Data. Article I. Data Access Committee Article I.1 Composition Gustave Roussy's Data Access Committee is composed of Fabrice Andre, Marta Jimenez and Alicia TRAN DIEN. Article I.1 Missions Gustave Roussy's Data Access Committee is responsible for authorizing access to the data. Article II. Request for access to data Article II.1 Composition of the application file The data access request file requires: - A summary of the study, research or evaluation according to the form decided by Gustave Roussy; - A scientific protocol including at least the details requested in the form; - The authorization decision of the National Commission for Information and Freedoms (Cnil) or a commitment to comply with a reference methodology published by Cnil signed by the data protection officer or by the legal representative of the requesting entity; - The list of funders of the study, if any; - The opinion issued by the scientific and / or ethical committee that evaluated the project and the composition of the committee (s), if any; - The confidentiality form; - The documentation necessary to demonstrate compliance with all its data protection and security obligations; Article II.2 Application procedures The request for access to the data is free. It is done by mail to the following address FABRICE.ANDRE@gustaveroussy.fr Article II.3. Examination of applications Following the filing of the file with the Data Access Committee, the latter: - verify its good orientation and completeness. Otherwise, the Data Access Committee will approach the requester to have the additions; - instruct the request for access to data within one month of receipt of the complete file. This time is given as an indication. Article III. Conditions of use of the data The applicant undertakes to respect all the following measures and to have them respected by his staff as well as any other person (s) assisting him with the use of the data: - To collect only data adequate, relevant, limited and strictly necessary to the specific treatment that it with these data; - Do not use the data to which he can access for purposes other than those indicated in the application file; - Disclose this data only to persons duly authorized by reason of their duties and who have been indicated in the data access request file; - Do not make any copy of this data except that it is necessary for the execution of his research; - Take all necessary measures to avoid misuse or fraudulent use of this data; ensure that only secure means of communication will be used to transfer this data; - At the end of the research project, to fully restore the data, computer files and any information medium related to these data. When this task falls within its remit, the applicant undertakes to ensure that the persons from whom I collect and / or use the data have been previously informed of the specific treatment that I am carrying out with their data. Article IV. Notification of data breach As soon as it becomes aware of this and within a maximum of twenty-four (24) hours, the requester notifies the Data Access Committee of any data breach. The requester provides to the Data Access Committee at the time of notification of the incident, or if this is not reasonably possible as soon as possible after the notification of the data breach, the following information regarding their violation: 1) The nature of the data breach; 2) The estimated number of people involved; 3) Categories of the person (s) involved; 4) the categories of Data concerned; 5) The estimated number of Data violated; Measures taken to remedy the data breach, including, where appropriate, measures to limit adverse effects and potential risks. The applicant shall as far as possible assist the Data Access Committee in reporting the data breach to the relevant control authorization and / or to the person (s) involved in the data breach. Article V. Data destruction At the end of the search, the applicant undertakes, after having made sure of the terms relating to reversibility: ☐ Destroy all Data ☐ Return all Data to the Data Access Committee ☐ To return the Data to the subcontractor designated by the Data Access Committee The return must be accompanied by the destruction of all data (including copies) in the information systems of the applicant and his / her