CRAFFT Patient Information
Want to find out more? Take a look at our FAQs below…
Who is involved in the study?
The study is funded by the Department of Health and is the work of children’s Emergency Doctors and Bone Specialists across the UK, with research support from The University of Oxford. The University of Oxford is the sponsor for the study and the day to day running of the study is being completed by Oxford Trauma, a research group of the Nuffield Department of Rheumatology, Orthopaedics and Musculoskeletal Sciences.
The research team is qualified to do this study because they have all the specialities and skills needed. The team has a lot of experience in caring for children and young people with injuries and are active in health research. Parents and children have been involved in the development of this study, and are involved in the management.
How will we use information about you and your child?
We will need to use information from you, your child and their medical records for this research project. This information will include:
- you and your child’s name,
- your child’s NHS number and date of birth
- your contact details
- secondary contact details.
Your child will be given a unique study identification number which will be used for all of the information we collect from you about your child. This information will be transferred to, and stored at, The University of Oxford, using a secure, encrypted web-based system.
Data protection regulation requires that we tell you about the legal basis for processing information about you and your child. In the case of research, this is “a task in the public interest”. The University of Oxford will act as the data controller. This means that the university are responsible for looking after your and your child’s information and using it properly.
People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are, will not be able to see your name or contact details. Your data will have a code number instead.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study. We will keep information about you safe and secure for at least 17 years after completion of the study, or until the youngest child reaches 21 years old (whichever is later) as per the University requirements for studies that include children.
Your treating hospital will collect and hold information about you, your child and/or your child’s medical records for this research study in accordance with our instructions.
We will keep identifiable information (contact details) about you for a minimum of 12 months after the study has finished.
What are your choices about how your information is used?
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
If you choose to stop taking part in the study, we would like to continue collecting information about your child’s health from your hospital or your GP. If you do not want this to happen, tell us and we will stop.
We need to manage your child’s records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about them.
If you agree for your child to take part in this study, the information collected about your child may be used to support other research in the future, and may be shared anonymously with other researchers.
Where can you find out more about how your information is used?
- Through the Health Research Authority – http://www.hra.nhs.uk/information-about-patients/
- HRA Leaflet available from https://hra.nhs.uk/patientdataandresearch
- At the CRAFFT website – https://CRAFFTstudy.org
- By asking one of the research team
- By sending an email to CRAFFT@ndorms.ox.ac.uk
- By calling us on 01865 228929.
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 participants’ interests. This study has been reviewed and given a favourable opinion by the West Midlands Black Country Research Ethics Committee.
What if there is a problem?
The University of Oxford has appropriate insurance in place in the unlikely event that your child suffers any harm as a direct consequence of their participation in this trial. NHS indemnity covers any other clinical treatment with which you are provided.
If you have a complaint or you have a concern about any aspect of the way you have been treated during this study, you should contact Professor Daniel Perry who is the overall study lead on 01865 228929 or email firstname.lastname@example.org or you may contact the University of Oxford Clinical Trials and Research Governance (CTRG) office on 01865 616480 or the head of CTRG email: email@example.com.
If you remain unhappy and wish to complain formally, you can do this by contacting NHS Complaints. Ask your treating hospital for the contact details or visit https://www.nhs.uk/using-the-nhs/about-the-nhs/how-to-complain-to-the-nhs/
Can I download a copy of the study information?
Yes, you can download the patient information by clicking these links: