Newcastle Clinical Trials Unit

Data Sharing

Data Sharing

NCTU Data Sharing Statement

NCTU recognises the that there may be significant value to patients and the wider clinical communicty in shargn data collected during trials and clinical studies.  NCTU is committed to enabling this to happen when appropriate.

Unless specific restrictions apply, all information sheets and consent forms for new studies being run in collaboration with NCTU will include a statement confirming our intention to share anonymised or pseudonymised data with the scientific community following the end of the trial/study. The following statement will appear in trial/study protocols:

"Data from this trial/study may be available to the scientific community subject to appropriate ethical approval. Requests for data should be directed to the lead author/Chief Investigator and Clinical Trials Unit.”

In certain circumstances data sharing may be planned to occur during the trial/study, and processes for this should be included in the protocol.

Principles for data sharing

The processing of requests for data sharing is iterative and will follow these guiding principles:

  1. Whether all required/expected publication outputs from the primary research have been completed. No data will be released if this will compromise an ongoing trial/study.
  2. That the request for data sharing comes from a reputable source (such as a dedicated research institute or established clinical researcher) and includes individuals suitably qualified to undertake the further analyses described in the request for data.
  3. Whether the proposed research that the data will inform is scientifically valid and acceptable.
  4. Whether there are any contractual, legal or ethical restrictions on the data being shared including compliance with the General Data Protection Regulations; when applicable an appropriate data sharing agreement will be required between the parties, and ethical approval may need to be sought.
  5. Whether there are sufficient funds available to undertake the preparation work to anonymise/pseudonymise the data prior to release if this has not previously been undertaken; where required, resource to undertake the work will be borne by the person/group requesting the data.

Who makes the decision?

During the trial any requests for data sharing must be submitted to the lead author/Chief Investigator who will consider requests in conjunction with Trial Management Group including senior members of the Clinical Trials Unit, Sponsor, and Oversight Committees.

After the trial/study has completed, approaches should be made to the Clinical Trials Unit who will consider requests in conjunction with the Chief Investigator, senior members of the Clinical Trials Unit, and Sponsor.