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Trial Data Use

 To carry out this research, we plan to collect three types of data:   

  • Personal details
  • Samples
  • Data from health records 

Personal Details

 We will need some personal details to carry out this out this research. This may include name, NHS number, postcode and date of birth. We will use the personal details to: 

  1. Contact people in the trial to book appointments, share study updates, ask for health information or check contact details 
  2. Collect and link relevant information from health records at local hospitals 
  3. Share samples with laboratories for testing  

Samples

 We will send the capsule sponge test samples to an accredited laboratory already used by the NHS for testing. This laboratory is run by Cyted Ltd. Samples will carry your NHS number and date of birth, like samples taken for routine care.

  

If you give blood and saliva samples, these will be stored at the University of Cambridge with a code number instead of your personal details. These will not be tested as part of this research but will be used in future approved research.  

Data from Health Records

 We will collect information from your local hospital records. This includes endoscopy results and images. As part of Heartburn Health, you gave us permission to collect information about your heartburn related health from national records in the UK. These may include records held by NHS England and other central UK NHS bodies. We will also use this information as part of this trial to look at long-term health consequences of heartburn and heartburn medication.   

Data Protection

 We will handle your data in line with the General Data Protection Regulation (GDPR) and the Data Protection Act 2018. Together, the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust are Data Controllers for the trial. This means that they will make decisions about how the data can be used. Queen Mary University of London will be the Data Processor for the trial. This means that they will be responsible for handling the data safely. Queen Mary University of London will be responsible for hosting the BEST4 database. They also have responsibility for ensuring the highest integrity of research data. Expert teams within Queen Mary University of London continually assess and ensure that data is held in the most appropriate and secure way. 


The database will be stored in a secure data centre provided by Arrow Business Communication Limited, a GDPR compliant data storage provider. Some employees of the third party will have access to your personal details and coded research data if needed for their role. They are required to keep your personal details and coded research data strictly confidential.  


People who do not need to know who you are will not be able to see your name or contact details. Your research data will have a code number instead.  We will keep all information about you safe and secure.   


We will use a third party called iPlato to process your personal details, contact you about the trial and manage appointment bookings. You can find out more about how they handle your personal details here https://www.iplato.com/privacy/.  


Your personal details will also be shared with Cyted Ltd. to test your capsule sponge sample. Cyted Ltd use third parties to process your personal details. You can find out more here https://cyted.ai/privacy.  


Your personal details may be reviewed by trial monitors, auditors, regulatory bodies and members of the research team during the trial. This is to check the quality and safety of the trial. These people will be required to keep your details secure. For more information about how we will use your personal details, please visit www.hra.nhs.uk/information-about-patients/

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