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 operation and follow-up will be sent by your doctors to the DREAMS 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 and/or applicable laws and regulations. This will include a signed copy of your consent form, including your full name. Your name and address will also be given to dedicated staff at the BCTU when you first enter the study, so that they can send Quality of Life questionnaires to your home address. Your GP, and the other doctors involved in your clinical care, will be notified of your participation in the DREAMS trial and kept informed of your progress. 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 BCTU. They may also be looked at by regulatory authorities. The purpose of this is to check that the study is being carried out correctly.
Once DREAMS 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 DREAMS, 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