Curation of myeloma observational study MALIMAR using XNAT: solving the challenges posed by real-world data.

"Declarations Ethics approval and consent to participateThe study protocol was reviewed by the Royal Marsden NHS Foundation Trust and Institute of Cancer Research Combined Committee for Clinical Research (CCR) and underwent proportionate review by the South Central — Oxford C. Research Ethics Committee in November 2017 (IRAS Project ID: 233501) and the Health Research Authority. The study was also approved for CPMS portfolio adoption (CPMS ID: 36766). The research was carried out in accordance with the Declaration of Helsinki (1996). Healthy volunteers included in the study consented to the study. Scans included from the prospective iTIMM study were consented for study entry and future use of data. Consent was waived for the use of de-identified retrospective data. The Royal Marsden NHS Foundation Trust and The Imperial College Healthcare NHS Trust acted as data controllers for the study, with the Institute of Cancer Research and Imperial College acting as data processors. The legal basis for processing data was “task carried out in the public interest” (GDPR Article 6.1(e)) with processing of special category (health) data permitted under GDPR Article 9.2(j) and appropriate safeguards implemented to satisfy the requirements of GDPR Article 89(1). Consent for publicationAs described above, the study’s ethics committee waived consent for the use of de-identified retrospective data. Furthermore, the current position of the UK’s Royal College of Radiologists on the use of patient images for teaching training and research [27] is this (our italics): “You may disclose anonymised or coded recordings for use in research, teaching or training, or other healthcare-related purposes without consent. In deciding whether a recording is anonymised, you should bear in mind that apparently insignificant details may still be capable of identifying the patient. You should be particularly careful about the anonymity of such recordings before using or publishing them without consent in journals and other learning materials, whether they are printed or in an electronic format. Explicit consent is only required if the patient is, or may be, identifiable”. Competing interestsThe authors declare that they have no competing interests. Competing interests The authors declare that they have no competing interests."

"Funding This study represents independent research supported by the Efficacy and Mechanism Evaluation (EME) Programme of the UK’s National Institute for Health Research (NIHR). Further support came from the Biomedical Research Centre, the Clinical Research Facility in Imaging and the Cancer Research Network at The Royal Marsden NHS Foundation Trust (RMH) and the Institute of Cancer Research, London (ICR). SJD was supported by CRUK funding C4278/A27066 for the National Cancer Imaging Translational Accelerator."