Data management and storage

Information in the form of routine clinical notes, measures and therapy recordings will be stored according to standard practice within the NHS service hosting the intervention. Hard copies of information/measures gathered as part of this research study will be anonymised and stored in a locked filing cabinet in a locked office in the Department of Psychology, University of Exeter, or the Spectrum Centre, University of Lancaster. Hard copies of data collected during assessments at the second study site may be stored temporarily and securely on NHS Trust premises before being transferred to Lancaster University. Consent forms will be stored separately from data, and data will be anonymised wherever possible. Data will be double-entered on a secure, web-based system maintained by the Clinical Trials Unit, University of Exeter.

The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository within the University of Exeter following completion of the trial. Anonymised data may be accessed and analysed by members of the project team and with researchers collaborating with members of the project team on the analysis of these data. With the exception of anonymised quotes from research interviews, consent from participants was not sought for sharing raw data publicly. Therefore, external researchers seeking to access the data for use in future projects must do so via request to the chief investigator (or her delegate), and projects using the data must have been approved in accordance with contemporary UK ethical and regulatory processes pertaining to the release of anonymised data under these circumstances.

Original research records will be retained for 7 years, after which they will be retained in electronic form and original records destroyed, including records of participant names and contact details, and audio files of semi-structured interviews (which will be retained only in transcribed form). The electronic records will be kept for 20 years after the end of the study. Published material will not contain patient-identifiable information.