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 was sent by your doctors to the ENDCaP-C 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. Your GP, and the other doctors involved in your clinical care, will be kept informed, but otherwise all information about you will remain confidential.
If you took part in the study, your relevant medical records may be inspected by authorised individuals from the BCTU or by the regulatory authorities. The purpose of this is to check that the study is being carried out correctly.
When the trial is complete, the results will be published in a medical journal and the funding body, National Institute of Health Research (NIHR) with publish the final report we submit to them (journalslibrary.nihr.ac.uk) but no individual patients will be identified. If you would like to obtain a copy of the published results, please ask your doctor.
You can decide not to continue with study participation at any time but, if you do, we would still like to follow up your progress. For this reason, your data and samples would remain on file and be included in the final study analysis. In line with Good Clinical Practice guidelines, at the end of the study, the data will be securely archived for a minimum of 15 years. Arrangements for confidential destruction will then be made. If you withdraw consent for your data to be used, it will be confidentially destroyed.
If you consent, the research staff involved in ENDCaP-C may, in the future, access electronic data from your central NHS records, for example through the Health and Social Care Information Centre (HSCIC). 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.
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.