Abstract
The source data verification of clinical trial data is approach to linking quality of data and for being harmless side of regulatory. However, the regulations do not define the limit of Source data verification. This flexibility gives a chance to introduce innovation and application of various methods, targeted and remote monitoring, adaptive monitoring schedules and real time reporting. The remote site monitoring is one of these innovative methods to ensure the quality of data which can save time and cost, which can be utilize on more productive activities such as R&D, implement new technology etc. And most importantly, it increases the work life balance of monitors.
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