The rapid expansion of clinical research requires modern clinical trials to be reliable. However, the current electronic trial master file (eTMF) solutions using traditional databases are fraught with severe drawbacks such as unreliability, imperfection, inaccuracy in version traceability, and redundancy of data. Clinical trial data is growing rapidly, and with these issues being unchecked, there is a high probability that it will lead to a massive degradation in the performance of eTMF systems, thereby hampering the efficiency of the documentation process. Additionally, it is evident that blockchain-based decentralized storage can save a substantial amount of time and effort for any researcher involved in clinical trial documentation. The article highlights a potential solution that can serve as the basis for a new digital TMF that can address the challenges of the dynamic and ever-evolving clinical trial data.
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