eprintid: 443 rev_number: 11 eprint_status: archive userid: 30 dir: disk0/00/00/04/43 datestamp: 2021-06-22 14:57:56 lastmod: 2021-06-22 15:00:18 status_changed: 2021-06-22 14:57:56 type: thesis metadata_visibility: show creators_name: Cullen, Karl corp_creators: Supervisor: Kathy Clarke title: The Impact of Blockchain Technology on Clinical Trial Data Integrity ispublished: submitted subjects: RS divisions: MScPBT full_text_status: public keywords: Blockchain Technology; Clinical Trial Data abstract: In this study it was shown how a new and emerging technology known as Blockchain, a data management platform, possesses the potential to address some of the predominant issues pertaining to clinical data integrity within clinical trial research studies. However, many obstacles and challenges persist with its implementation and these must be addressed, understood and solved before the technology can be utilized to manage clinical data. The main research objective of this study was to examine how Blockchain could be suited to address the concerns relating to clinical data integrity and to address the perceptions of participants involved with clinical data management to the technology and its potential application within clinical trials. Through an exploratory quantitative and qualitative mixed methods approach aligned with a pragmatist research philosophy, primary data was collected from participants who were purposively selected from a homogenous sampling pool that consisted of those with backgrounds in clinical data management. Primary data produced from this study highlighted the correlation of data issues that contribute towards the lack of integrity of clinical data with those found in secondary research. It was also found that the perception of Blockchain was generally positive and favorable towards its adoption within clinical trials. However, there was a degree of uncertainty surrounding the security of data within Blockchain. Various challenges were identified, primarily, the complexity of the technology and challenges related to compliancy with data protection laws. The conclusive determination of Blockchain’s suitability to address clinical data concerns, however, remains unanswered and further research is needed to test the application of Blockchain in real-world clinical trial environments. Further research and studies are also necessary to address the many challenges that face Blockchains implementation with clinical data management. date: 2020 date_type: completed institution: Griffith College department: Innopharma thesis_type: masters referencetext: Albanese, G. et al. (2020) ‘Dynamic consent management for clinical trials via private blockchain technology', Journal of Ambient Intelligence and Humanized Computing. doi: 10.1007/s12652 020-01761-1. Alshamsi, A. and Andras, P. 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