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 was sent by your doctors to the SUNRRISE 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.
The University of Birmingham is the sponsor for the SUNRRISE study. The University will use information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that The University of Birmingham is responsible for looking after your information and using it properly. Identifiable information will be kept about you for up to 10 years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
Your GP and the other doctors involved in your clinical care will be notified of your participation in the SUNRRISE study and kept informed of your progress. Also, the research staff involved in the study may, in the future, access electronic data from your central NHS records, for example through NHS Digital. This will provide researchers with information that is routinely gathered and stored during your visits to primary care and hospital, and will allow researchers to find out about your health after the trial has ended and the long-term effects of the treatments. By using routinely collected data we will be able to do this without needing to contact you further. In order to do this, we would need to send your name, gender, date of birth and NHS number with any request for information. All information about you and your treatment will remain confidential.
Your hospital will use your name, NHS number and contact details to contact you about the SUNRRISE study. With your permission, your relevant medical notes may be inspected by authorised individuals from the University of Birmingham. They may also be looked at by regulatory authorities. The purpose of this is to check that the study is being carried out correctly. Your hospital will pass these details to The University of Birmingham along with the information collected from you and your medical records. The only people in The University of Birmingham who will have access to information that identifies you will be people who need to contact you to remind you to complete questionnaires, arrange and/or complete follow-up or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.
The manufacturer of the SUNPD dressings may review limited information about any complications experienced by those in the SUNPD dressing treatment group. This data will all be anonymised and will not identify you.
Researchers l have developed a questionnaire as part of their Bluebelle study. This can be completed by you at home without the need to be seen in hospital. In the future this may mean patients do not need to return to hospital and this would make this type of research easier. At present we are not sure that this questionnaire will identify all of the wound infections that occur but the SUNRRISE study may be able to answer this question. Therefore, we would like you to complete the Bluebelle questionnaire which will be found in your Patient Diary.
Authorised individuals from the Clinical Trials and Evaluation Unit Bristol at the University of Bristol may be sent and review part of the data that collected about you. This will include your age, the type of operation that you had and whether or not you had a wound infection along with your responses to the Bluebelle wound healing questionnaire questionnaire. This data will all be anonymised and will not identify you.
Once SUNRRISE has finished we will publish the results in a medical journal so that others can benefit. No individual patients will be identified in any publications. In line with clinical trial guidelines, at the end of the study, the data will need to be securely archived for a minimum of 10 years.
For more information on how we use your data please see the Birmingham Clinical Trials Units' Data Sharing and Protection Policy.
More information on how the University processes personal data can be found on the University’s website on the page ‘Data Protection – How the University Uses Your Data’ (http://www.birmingham.ac.uk/privacy/index.aspx).