Will my taking part be kept confidential?
If you decide to take part in CReST2, all 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 condition and personal details such as your initials, date of birth, NHS/CHI number, hospital number and postal address will be sent by your doctors to the CReST2 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 Data Protection Act (2018). This will include a signed copy of your consent form, which will include your name.
Your GP, and the other doctors involved in your clinical care, will be notified of your participation in the CReST2 trial. We may use national NHS records to track your progress. Any information about you and your treatment will always be treated confidentially and will be held on a secure SSL server within the University of Birmingham. A small number of trial office staff will have access to the data via a secure university network. Access to these data will be limited to the member of the trial team who needs to access the data in order to deliver the study outcomes.
With your permission, your relevant medical records may be inspected by authorised individuals from the University of Birmingham Clinical Trials Unit (BCTU). They may also be looked at by the NHS Trust, the trial Sponsor or the regulatory authorities to check that the study is being carried out correctly.
Manchester University NHS Foundation Trust is the Sponsor for this study. The Birmingham Clinical Trials Unit at University of Birmingham will be using information from your medical records in order to undertake this study and so will act as the data controller for this study.
The legal justification we have under data protection law for processing your personal data is that it is necessary for our research which is a task we carry out in the public interest. These data will not be used to make decisions about you.
Can I access my data?
As a trial participant it is your right to access, remove, or correct inaccurate personal information the University holds about you. This is known as a Subject Access Request. More information about this can be found at https://www.birmingham.ac.uk/research/bctu/data-protection.aspx.
What will happen to the results of the study?
Once the trial 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 www.birmingham.ac.uk/crest2. 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 CReST2.
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. Following this 10 year period your data will be securely destroyed.
Who is organising and funding the research?
The CReST2 study was developed by the National Cancer Research Institute's Colorectal Cancer Clinical Studies Group, and is funded by the National Institute of Health Research’s Health Technology Assessment Programme.
The study is being coordinated by the Birmingham Clinical Trials Unit at the University of Birmingham. The research has been reviewed and approved by all of these organisations, and also by an independent NHS Multi-centre Research Ethics Committee. There is no involvement of any commercial company in this study.
Who has reviewed the study?
All research in the NHS is looked at by an independent group of people called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity. This study has been reviewed and given favourable opinion by Tyne and Wear South Research Ethics Committee (Ref: 17/NE/0027).