Users of the data provided are required to fully comply with the Data Protection Act 1998, as well as all other related and relevant laws and guidelines of the Ministry of Health regarding data exchange issues, including: The original data source is temporarily stored in a file server directory that only the principal investigator and principal investigator can access until they access an AES 256 encrypted volume is carried forward. The data is processed and imported from the encrypted volume into a Microsoft 2005 SQL Server database hosted in the University of Warwick data center. Data is regularly replicated to a failover server and regularly backed up to a storage area network. The data will be used to develop an PGD REPOSITORY on potential facilitators, health outcomes, use and cost of healthcare resources, from RCTs that test therapist-led interventions for back pain. We will perform statistical and health economic analyses on this aggregated dataset. The University of Warwick wishes to formally acknowledge its explicit commitment to maintaining the confidentiality, security and integrity of all data of which the organisation is aware and which may be held under its guardianship. Data come from completed randomised controlled trials. All data is anonymous and no information that can identify the patient is shared. Ideally, these additional concerns should be addressed in the data sharing agreement in order to facilitate clear communication and, if necessary, put in place additional safeguards: permission to obtain data is obtained from the University of Warwick`s Biological Research Ethics Board and the Oxford NHS REC “C”. Finally, data from multiple sources can often be combined to allow comparisons between national and departmental boundaries. The University of Warwick continues to legally enter into a formal agreement and/or implied commitment with all its customers, employees, visitors, suppliers and others, recognising that data stored under the tutelage of the University of Warwick that is relevant to the individual client, employee, visitor, supplier and/or others, will only be used for the expressly agreed purposes, for which it has been made available, and that there will be no unlawful disclosure or loss thereof. A data sharing agreement is a formal contract that clearly documents what data is shared and how the data can be used.

Such an agreement has two objectives. First, it protects the organization providing the data and ensures that the data is not misused. We will not reanalyze previously published study data. Patel S, Hee SW, Mistry D, et al.; the repository group. Subgroup identification for back pain: Development and application of approaches using individual patient data collected in clinical trials. Southampton (United Kingdom): NIHR Journals Library; Jul. 2016 (Applied Research Program Grants, No. 4.10.) It is intended to preserve the repository after its development and to make it available to other researchers.

An independent steering committee will be convened to assess applications for filing. Anonymous data is collected by [INSERT NAME OF INSTITUTION]. The data is encrypted and sent to the University of Warwick via [INSERT INSTITUTION NAME] via the university`s file transfer app. With encrypted data, [INSERT INSTITUTION NAME] provides a detailed description of the variables. Data sharing is an important way to improve the ability of researchers, scientists and policymakers to analyze data and translate it into meaningful reports and knowledge. Data sharing prevents duplication of data collection and encourages diversity of thinking and collaboration, as others are able to use the data to answer questions that the original data collectors may not have considered. Here is a list of the elements that are typically included in a data sharing agreement. While this list may cover the basics, additional concerns may be relevant to a particular dataset or vendor agency.

Second, it avoids misunderstandings on the part of the data provider and the organization receiving the data by ensuring that all questions about the use of the data are discussed. Prior to the data exchange, the provider and recipient must speak in person or by telephone to discuss data sharing and use issues and to reach a joint agreement, which is then documented in a data exchange agreement. Access to the data is limited to the persons named in Table A of this Agreement. All changes are reported to [INSERT NAME OF ESTABLISHMENT]. It is important to recognize that the process of setting up data exchange agreements varies from country to country, as well as the type of data shared and the agencies that share the data. This Agreement shall enter into force on [INSERT DATE] and shall terminate on [INSERT DATE], unless it is renewed by mutual written agreement of both parties, after which the University of Warwick issues an amendment to replace this document. The WCTU may invoke the right to implement the research opt-out of the Data Protection Act in order to retain the data for future research activities. Once the data is received, the original source is moved to an encrypted drive. A processed copy of the data is imported into a secure database. [INSERT NAME OF ESTABLISHMENT] provides all anonymous study data from [INSERT TRIAL NAME]. Required data: If the repository is considered no longer needed, all data is deleted from the servers.

Data deletion is irreversible and involves disconnecting from the database and destroying all transaction data and files with a secure deletion application. Individual patient data with variable coding descriptions We need confirmation from the principal investigator that patients in the original study have given informed consent. Print Name: Professor Martin UnderwoodPrint Name: Position/Title: Head of Health Sciences Division, Warwick Medical School Position/Title: Warwick Clinical Trials Unit [INSERT INSTITUTION NAME] Text adapted from The Capacity Project www.capacityproject.org/hris/. Research Project Title: Improving Outcomes in the Treatment of Back Pain. .