1.0 Organisations

This Data Sharing Agreement is drawn up between:

Professor Martin Underwood

Warwick Clinical Trials Unit

University of Warwick

Gibbet Hill

Coventry

CV4 7AL

and:

[INSERT DETAILS]

2.0 Period of agreement

This agreement commences on [INSERT DATE] and will terminate on [INSERT DATE] unless extended by mutual agreement of both parties in writing, at which point an Amendment will be issued by University of Warwick to replace this document.

3.0 Data required

[INSERT INSTITUTION NAME] will supply all anonymous trial data from [INSERT TRIAL NAME]. Data required:

Individual patient data with descriptions of variable coding

AND/OR

Scored variable databases with descriptions of variable coding

We will require confirmation from the Chief Investigator that patients in the original trial have given informed consent.

4.0 Permissions

The data will come from completed randomised controlled trials. All data will be anonymous and no patient identifiable information will be shared.

Approval to obtain data will be obtained from the University of Warwick’s Biological Research Ethics Committee and the Oxford ‘C’ NHS REC.

5.0 Purpose for which the data are to be used

The data will be used to develop a repository of IPD on potential moderators, health outcomes, and health-care resource use and costs, from RCTs testing therapist-delivered interventions for low back pain. We will conduct statistical and health-economic analyses on this pooled data set.

We will not reanalyse any trial data already published.

Data access is restricted to those named in Table A of this agreement. Any changes will be notified to [INSERT INSTITUTION NAME].

TABLE A

Individuals who will have access to and use of the repository

6.0 User obligations

The University of Warwick formally wishes to acknowledge its explicit commitment to maintaining the confidentiality, safety, security and integrity of all data to which the organisation is privy and which may be held under its guardianship.

The University of Warwick continues to legitimately enter into formal agreement and/or implicit undertaking with all its clients, staff, visitors, suppliers and others, in recognition of the fact that the data are held under the guardianship of the University of Warwick which is pertinent to the individual client, staff member, visitor, supplier and/or other, will only be used for the explicit agreed purpose or purposes for which it has been provided, and that there will be no unlawful disclosure or loss of the same.

Users of the data supplied are obliged to fully comply with The Data Protection Act 1998, together with all other related and relevant legislation and Department of Health directives covering issues of data sharing and including:

• British (International) Standard ISO 27001
• The Caldicott Report 1997
• The Freedom of Information Act 2000
• Section 251 of the Health and Social Care Act 2006
• Confidentiality: NHS Code of Practice 2003
• NHS Records Management Code of Practice (Part 1, 2006 & Part 2, 2009)
• The NHS Information Security Management Code of Practice 2007
• The Computer Misuse Act 1990
• The Electronic Communications Act 2000
• The Regulation of Investigatory Powers Act 2000
• The Copyright, Designs and Patents Act 1988
• The Re-Use of Public Sector Information Regulations 2005
• The Human Rights Act 1998.

7.0 Transfer of data from [INSERT INSTITUTION NAME] and the University of Warwick

Anonymous data will be obtained from [INSERT INSTITUTION NAME]. Data will be encrypted and sent to the University of Warwick by [INSERT INSTITUTION NAME] via the University’s file transfer application.

Once the data have been received, the original source will be moved to an encrypted drive. A processed copy of the data will be imported into a secure database.

Together with the encrypted data [INSERT INSTITUTION NAME] will provide a detailed description of the variables.

8.0 Storage of data

The original data source will be temporarily stored on a file server directory that is only accessible to the chief investigator and study manager until it is moved to an AES 256 encrypted volume. Data will be processed and imported from the encrypted volume into a Microsoft 2005 SQL Server database hosted in the University of Warwick’s data centre. The data will be regularly replicated on to a failover server and routinely backed up to a Storage Area Network.

9.0 Data retention

The intention is to keep the repository once it has been developed and make it available to other researchers. An independent steering committee will be convened to assess applications for the repository.

If the repository is deemed to be no longer required, all data will be deleted from the servers. Deletion of data is irreversible and involves the database being disconnected and all data and transaction files being destroyed using a secure deletion application.

The WCTU may invoke the right to implement the research exemption clause of the Data Protection Act in order to retain the data for future research activities.

10.0 Agreement signatures

For and on behalf of:  For and on behalf of:

Warwick Clinical Trials Unit  [INSERT INSTITUTION NAME]

Signed:  Signed:

Print name: Professor Martin Underwood  Print name:

Post/title: Head of Division of Health Sciences, Warwick Medical School  Post/title:

Date:  Date: