183 7 Research Data Management Research Data Management This thesis is based on the results of human studies, which were conducted according to guidelines for Good Clinical Practice. All studies were granted ethical approval by the research and development committee of the Woman’s and Children’s Hospital NHS Trust (BWCH). None of the studies were subject to the medical research involving human subjects act (WHO). Oticon Medical AB (Askim, Sweden) supported the studies in chapter 2 and 3. MED-EL (Innsbruck, Austria) supported those studies in chapter 4. No financial grants were given from either company. Data ownership from all included studies resides with BWCH. There are no actual or potential conflicts of interest including any financial, personal, or other relationships with other people or organizations that could inappropriately influence, or be perceived to influence, their results of all the published studies in this thesis. All data presented in this research was recorded, analyzed, and interpreted by BCWH independently. No person or institution provided financial support to conduct or prepare this research. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Prior to patient inclusion, written informed consent was obtained following BWCH protocol. In studies included in chapter 2 and 3, patients demographics, outcome, surgical methodology and RFA data were recorded on paper case report forms. Furthermore, with regards to studies included in chapters 2-4, patient specific paper questionnaires were completed at regular interval defined by the study design, all papers were stored securely within the audiological departments site file for update and reference. On completion of each study this data was converted to electronic format in Excel and combined with audiological data. This was stored on a secure internal ENT department system and access granted to only those individuals with a role in the project. The privacy of the participants is this thesis has been preserved by the allocation of individual patient identification numbers which corresponds to all data collected as well as consent documents and questionnaires. All primary and secondary data that was obtained for the studies described in chapters 2,3 and 4 (including raw data, data analysis, results and manuscripts and all other relevant files) have been stored on secure computers with password encrypted access.
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