Data management
Data were collected using a mix of paper and electronic methods. Where possible a patient ID number was used rather than identifiable information. Data from paper forms were transcribed into an electronic database in Microsoft Excel stored on secure NHS servers. Paper hard copies were stored at Derby CTSU and in the relevant Investigator Site Files (ISF). Study documentation was stored securely to maintain participant confidentiality and study data integrity.Electronic data captured at trial sites was uploaded to a secure electronic ISF on Microsoft Sharepoint. Online outcome data collection was managed by Amplitude Clinical in ISO27001 Tier 3+ data centres approved for use by the NHS.