SPONSOR: Imperial College London
STUDY NAME: The WHEAT pilot trial: WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multi-centre, electronic patient record (EPR), randomised controlled point-of-care pilot trial
IRAS ID: 154432
Imperial College London is the sponsor for this study based in the United Kingdom. We will be using information from your baby’s medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. The Neonatal Data Analysis Unit at Imperial College London will keep this identifiable information about you and your baby for 25 years after the study has finished in a National Health Service (NHS) secure environment at Chelsea and Westminster NHS Foundation Trust.
Your rights to access, change or move you or your baby’s information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. To safeguard you and your baby’s rights, we will use the minimum personally-identifiable information possible. You can find out more about how we use your information by contacting the Chief Investigator Dr Chris Gale at email@example.com.
Imperial College London will use you and your baby’s name, NHS number and date of birth to make sure that relevant information about the study is recorded for your care and to oversee the quality of the study. Individuals from Imperial College London, NPEU CTU and regulatory organisations may look at your baby’s medical records to check the accuracy of the research study. The only people in Imperial College London or NPEU CTU who will have access to information that identifies you or your baby will be people who need to 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 you or your baby’s name or NHS number.
When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research. This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.