Guidelines for Access to Data from the CRPS UK Registry
This document refers to the use of demographic and questionnaire data from the CRPS UK Registry and does not include other studies, including studies that have directly contacted patients whose information has been recorded in the Registry.
1 The CRPS UK Clinical Research Network was established in 2006 and is a research collaboration between a number of UK NHS Trusts and academic institutions with an interest in Complex Regional Pain Syndrome. The CRPS UK Registry was established by this group in 2008 to facilitate epidemiology studies, academic and pharmaceutical clinical trials. It is hosted by the University of Southampton, supervised by a Steering Committee, sponsored by Cambridge University Hospitals NHS Foundation Trust, and funded by ad hoc grants. The CRPS UK Registry data remain the property of the Steering Committee.
Analyses under 2008 MREC agreement and other protocols
2 Basic analyses approved by the participating Centres under the 2008 MREC protocols will be carried out under the direction of the Steering Committee.
3 Use of CRPS UK Registry data for other purposes requires authorisation of the Steering Committee.
4 Any request for use of CRPS UK Registry data must be submitted to the Chairman of the Steering Committee, who will circulate it to the Steering Committee. For requests for use of data from a member of the CRPS UK Registry Working Group (internal request), Steering Committee members and those of the Working group will be expected to inform the Chairman of their approval (or alternatively of any objections they may have) within a reasonable time, say within two weeks of circulation. Requests for use of data from external bodies will require discussion at the next Steering Committee meeting.
5 The Chair of the Steering Committee, in collaboration with the CRPS UK Registry Support Administrator, will oversee the preparation of data to meet such requests. Data selections, in accordance with the specified criteria, will only be carried out after formal authorisation from the Steering Committee.
Format of requests for use of data (see Appendix 2 Data access form)
6 The request must include the names and affiliations of the individuals who will be responsible for the data analysis, interpretation and subsequent publication of any articles. A short protocol (1-2 pages) will be required, setting out :
6.1 the rationale for the study;
6.2 the aims of the study;
6.3 the methods of the proposed analysis;
6.4 a detailed description of the CRPS UK Registry data items requested;
6.5 the proposed time schedule for the study.
Data will not be selected until these requirements, and those detailed under ‘Conditions for use of data’ have been met and approved by the Steering Committee.
Protocol
7 The purpose of requesting a protocol is:
7.1 to prevent duplication of effort and to enable the Steering Committee to bring together investigators with similar interests;
7.2 to provide sufficient justification for use of the data by the Steering Committee;
7.3 to enable the Committee to provide any advice that may be required on practical aspects of data preparation and on the interpretation of the data.
Conditions for use of data
8 The principal investigator requesting the data must sign an agreement to abide by the following conditions which apply to use of CRPS UK Registry data (see Appendix 1):
8.1 The data will only be used for the purpose(s) stated in the protocol accepted by the Steering Committee;
8.2 The data will not be released to a third party;
8.3 The data will be anonymised and treated as confidential and will be used only for statistical purposes.
8.4 A copy of any manuscript arising from such analysis should be submitted to the Steering Committee for review; submission for publication should only be made after the Steering Committee has responded, which will normally be within 4 weeks of receipt of the manuscript.
8.5 Any publication must acknowledge the contribution of data by the CRPS UK Registry Working Group members, as set out in the CRPS UK Registry Publication Policy.
8.6 The requester must agree to provide an e-version (preferably PDF) of any publication for distribution to Working Group members.
Generation of new data
9. If data analysis involves the creation of new variables – e.g. summary variables from existing data, or the combination of data from different scales – these new variables should be deposited with the Steering Committee for inclusion in the Registry Core dataset.
Appendix 1
Agreement of Principal Investigator to abide by Guidelines
for Access to Data from the CRPS UK Registry.
Project title submitted to CRPS UK Registry Steering Committee:
…………………………………………………………………………………………
Project number (to be added by CRPS administrator):……….
Undertaking by Principal Investigator
I have read and understood the guidelines Access to Data from the CRPS UK Registry. I undertake to abide by these Guidelines.
Signature ………………………………………………………....
Name ………………………………………………………………………..
Position ……………………………………………………………………..
Institute Address
…………………………………………………………………………………………
…………………………………………………………………………………………
…………………………………………………………………………………………
E-mail……………………………………………..
Phone and Fax Numbers………………………………………………..
Date…………………………..
Approval by CRPS UK Registry Steering Committee
The Steering Committee has agreed to approve this project access to the CRPS-UK Registry data requested:
Steering Committee Chairman:…………………………………….
Date: …………………………..
Appendix 2
Data access form
Please expand boxes, if necessary1 / Study title:
2 / Primary hypotheses:
3 / Please provide brief background and protocol for proposed analysis: / May be provided on separate sheet.
4 / Please list all personnel involved in the study.
5 / What data do you require?
Please include timescales for recruitment and study end date.*
6 / What is the timescale for analysis?
7 / Has funding and / or ethics been obtained?
8 / Has this protocol been peer-reviewed? / If so, please indicate where. Please list the reviewer(s), if known.
*Due to the active enrolment of patients and the changing nature of the data, each data release is time-limited and will require publication within 1 year. This is to avoid delay of data release to other groups.
Upon completion of analysis, a report will be required to be submitted, regardless of whether publication is anticipated.
Version 5 04.10.13