Who is responsible for and has access to my data during the study?
The two parties involved in this trial (the University of Oxford, whose full legal name is “The Chancellor, Masters and Scholars of the University of Oxford”, and Boehringer Ingelheim International GmbH) will be responsible for deciding how any personal data collected during this study are processed and will ensure data protection laws are followed (ie they will be the “data controllers”). Both parties are bound by a duty of confidentiality.
Only staff with appropriate training and permission can access the bespoke computer system used to store your data. Personal data that directly identifies you such as your name, address, or date of birth (so-called personal identifiers) can be accessed by the EASi-KIDNEYTM doctors and nurses who are running the study at your local hospital. Health regulators (such as the UK MHRA and U.S. FDA) and auditors from Boehringer Ingelheim could also access these data if they were to ever visit your local hospital to check that the study is being carried out properly. (Such visits may be conducted remotely through an appropriate platform). These people are also all bound by a duty of confidentiality.
During the study, a member of the Oxford University team or other EASi-KIDNEYTM staff may ask your permission to be present during your clinic appointment to observe a visit. This helps us ensure study procedures are being followed.