Pragmatic Clinical Trials Unit

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Data Sharing Committee

In order to ensure that PCTU meets its ongoing commitment to the fair and responsible sharing of study data, a Data Sharing Committee has been appointed by the unit'sSenior Management Group to oversee data sharing on behalf of the department, in line with the PCTU Data Sharing Policy [PDF 271KB].

The Data Sharing Committee is responsible for reviewing all incoming requests from researchers to access data arising from PCTU supported studies, as well as developing policies, procedures and guidance to support the unit's growing data sharing activities and offering advice both within the team and externally.

Purpose and remit

The Data Sharing Committee is reponsibile for ensuring that all data sharing carried out by the organisation is handled in accordance with good practice principles and applicable laws and legislation.  

The committee's main role is to review all incoming requests to access clinical research data from researchers not involved in the original study and after the main results have been published.

The Data Sharing Committee reviews applications on a case-by-case basis to establish:

  • That there is a valid purpose for sharing the data and that the associated research proposal has suitable scientific merit.
  • That the data requested are suitable and proportionate for fulfilling the aims stated in the proposal.
  • That any risks associated with sharing the data, such as the liklihood of re-identification, either directly or indirectly, are appropriately mitigated.
  • That appropriate steps have been taken to anonymise the data, taking into acocunt whether consent for data sharing was sought from participants in the original study. 
  • The the data security assurances provided by the recipient institution are suitably rovust where data will be transferred outside of PCTU's data safe haven.

The Data Sharing Committee also facilitates data sharing by offering advice on data sharing principles; supporting members of the department in sharing study information in order for agreements to be drawn up and ensuring that documents are approved and transfers of data completed in a timely manner.


Membership of the committee is drawn from across the various teams within the PCTU.

The committee includes a senior member of the Data Management team and a Senior Statistician to offer expert advice on data and data sharing.

The Caldicott Guardian also attends meetings to provide experise in matters involving confidentiality and to ensure that data sharing is carried out in line with the Caldicott principles. 


The Data Sharing Committee meets on a monthly basis. To find out when future Data Sharing Committee meetings will be taking place, please contact the committee by email.

The Data Sharing Committee is primarily concerned with data arising from closed studies where planned analysis has been carried out or is in progress. 

Researchers requiring access to study data to carry out analysis described in the protocol should contact the sponsor or study team. Find out more about our ongoing studies here and find contact details for all of PCTU's staff here.

You can contact the Data Sharing Committee by email to discuss any aspect of their work, PCTU's approach to data sharing or any queries you may have regarding an upcoming request.

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