1. Data source – Trial participant data will be stored on the national screening computer system (NBSS). Access to data on NBSS is password protected and is in accordance with the regulations and operating procedures within each of the trial sites. Access to trial participant data at the trial sites is limited to those involved in the direct clinical care of trial participants and the local trial data manager.The managers of the Central Trial Database at RSCH will need limited access in order to set up the anonymization process.
  2. Time points for collection – Data on screening trial participants entered as routine at screen reading, assessment and following treatment
  3. Screen readers, assessment team, local service data managers will collect the data
  4. Data for trial participants will be downloaded and transferred to a central trial database which will be under the supervision of Dr Mark Halling-Brown at the Royal Surrey County Hospital, Guildford. Trial participants will be electronically labelled on the NBSS. A trial data set will be downloaded for each trial participant. Each trial participant will be given a unique trial number. Trial participant data will be held on an NHS computer and will be encrypted, password protected and pseudo-anonymised. Storage of trial participant data will be compliant with the Data Protection Act and with NHS Caldicott Guardian Regulations.
  5. Participant trial data will be accessible at each of the screening sites by those responsible for the direct clinical care of the trial participants.
  6. Anonymised data and images will be accessible by members of the trial steering group for data and image analysis.
  7. Patient anonymity will be protected and maintained. Information with regards to study patients will be kept confidential and managed in accordance with the Data Protection Act, NHS Caldicott Guardian, the Research Governance Framework for Health & Social Care and Research Ethics Committee approval.
  8. The CI is the custodian of the data.
  9. No patient details to be transferred out of the EU
  10. All patient data will be anonymised with regards to publications relating to the study.