Information collected about you during the course of the trial will be kept strictly confidential in the same way as all of your other medical records. Information about your disease and progress will be sent by your doctors to the TREC Study Office at the University of Birmingham Clinical Trials Unit (BCTU), on paper and electronically, where it will be securely stored under the provisions of the 2018 Data Protection Act. This will include a signed copy of your consent form. Your GP, and the other doctors involved in your clinical care, will be notified of your participation in the TREC trial and kept informed of your progress. We may use national NHS records to track your progress, but otherwise all information about you and your treatment will remain confidential.
With your permission, your relevant medical records may be inspected by authorised individuals from the University of Birmingham Clinical Trials Unit (BCTU). They may also be looked at by the medical charity, Cancer Research UK (that is funding the study), the NHS Trust or the regulatory authorities to check that the study is being carried out correctly.
Once the trial has finished we will publish the results in a medical journal so that others can benefit. We will also publicise the results on the trial’s website. No individual patients will be identified in any publications. A copy of the published results of the trial will be sent to all patients who have participated in TREC, on request. In line with clinical trial guidelines, at the end of the study, the data will need to be securely archived for a minimum of 15 years. Arrangements for confidential destruction will then be made.
Your data is held, with your permission, in the interest of public health, and in line with the current Data Protection Act (2018).
You can find more on how we use your information:
The Data Protection Office, Legal Services, The University of Birmingham, Edgbaston, Birmingham B15 2TT.
Email: dataprotection@contacts.bham.ac.uk Telephone: 0121 414 3916