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Confidentiality

 

All information collected during the course of the trial will be kept strictly confidential. Study data will be held securely on paper and, on an electronic database satisfying MoD security requirements at the DMRC Headley Court and KCMHR (King’s College London). Access to the database will be restricted to authenticated, named users logged into either the KCL network or MoD network. The data collected will strictly only be used in this research and other relevant military research. All staff are required to sign a confidentiality agreement, reminding them of their obligations and the disciplinary action which would result from a breach. The study will comply with MoD standards for handling personal data. No individual will ever be identified in reports or publications. All reports will be on aggregated data. DMRC Headley Court and ADVANCE Study staff will comply with all aspects of the Data Protection Act 1998 and operationally this will include: Consent from patients to record personal details including name, date of birth, address and telephone number, service number, NHS number, GP name and address. Appropriate storage, restricted access and disposal arrangements for patient personal and clinical details. Consent from patients for access to their military and NHS medical records by responsible individuals from the research staff, the sponsor or from regulatory authorities, where it is relevant to trial participation. (NHS REC approval will be sought)  Consent from patients for the data collected for the trial to be used to evaluate safety and develop new research.