If you decide to take part in ElaTION, all information collected about you during the course of the study will be kept strictly confidential in the same way as all of your other medical records. Information about your treatment and follow-up will be sent by your doctors to the ElaTION 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, including your full name. Your GP and the other doctors involved in your clinical care will be notified of your participation in the ElaTION trial and will be kept informed of your progress. We may use national records to track your progress, but otherwise all information about you and your treatment will remain confidential.
As we may also contact you by post to ask you to complete questionnaires asking about your progress, we will ask you to give us your permission to do so. With your permission, your relevant medical notes may be inspected by authorised individuals from the BCTU and InHANSE. 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 ElaTION has finished we will publish the results in a medical journal so that others can benefit. We will also publicise the results on the study’s website. No individual patients will be identified in any publications. A copy of the published results of the study will be sent to all patients who have participated in ElaTION upon 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. Should you withdraw consent for your data to be used, it will then be confidentially destroyed.
Your data is held, with your permission, in the interest of public health, and in line with the current Data Protection Act (2018).
For more information on how we use your data please see the Birmingham Clinical Trials Units' Data Sharing and Protection Policy.