Data sharing policy

Participant data and the associated supporting documentation will typically be available for CRCTU clinical trials, which commenced after the 1^st of April 2009, within 6 months after the publication of the outcome measures* unless it is not possible to share the data (for example: it is not possible to anonymise the data in accordance with the MRC guidelines, the trial results are to be used as part of a regulatory submission, the release of the data is subject to the approval of a third party who withholds their consent, the data is not owned by the University of Birmingham). Requests for historical clinical trial data will be dealt with on a case-by-case basis.

* For trials with long term follow-up, primary outcome data (e.g. response) may be available before secondary outcome data (e.g. survival).

Only scientifically sound proposals from appropriately qualified Research Groups will be considered for data sharing. Requests should be made by returning a completed Data Sharing Request Form and Curriculum Vitae of the lead applicant and statistician to newbusiness@trials.bham.ac.uk. The Data Sharing Request Form captures information on the specific requirements of the research, the statistical analysis plan, and the intended publication schedule.

The request will be reviewed independently by the CRCTU Directors in discussion with the Chief Investigator and relevant Trial Management Group (TMG) and/or independent Trial Steering Committee (TSC) (as applicable to the trial). For historical trials where the research group has been disbanded the decision will be made solely by the CRCTU Director’s Committee.

In making their decision the Director’s Committee will consider the scientific validity of the request, the qualifications of the Research Group, the views of the Chief Investigator and TMG and/or TSC, consent arrangements, the practicality of anonymising the requested data and contractual obligations.

Where the CRCTU Directors and appropriate Trial Committees are supportive of the request, and where not already obtained, consent for data transfer will be sought from the Sponsor of the trial before notifying the applicant of the outcome of their request.

It is anticipated that applicants will be notified of a decision within 3 months of receipt of the original request.

A Data Sharing Agreement will be put in place between the respective organisations to support the release of data once approved. The Data Sharing Agreement will prohibit the Research Group from attempting to identify trial participants and further distributing the data without permission.  It will also address publication requirements including authorship and acknowledgements.

Supporting documentation including the trial protocol and Case Report Form will be provided and data will be made available as soon as practically possible after signature of the agreement.

An anonymised encrypted dataset will be transferred using a secure method. 

Where the data analysis forms part of a future funded project the CRCTU would expect legitimate costs of transferring the dataset to be included within the grant application. For all other types of activity the CRCTU does not charge for provision of this service.

Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials. Tudur Smith C, Hopkins C, Sydes M, Woolfall K, Clarke M, Murray G, Williamson P. April 2015” (see www.methodologyhubs.mrc.ac.uk/files/7114/3682/3831/Datasharingguidance2015.pdf)

Cancer Research UK Policy on Data Sharing and Preservation www.cancerresearchuk.org/sites/default/files/cruk_data_sharing_policy_2017_final.pdf