Technology and Regulatory Submissions

The best clinical practice in any clinical study is ensuring the safety of human subjects while enhancing scientific knowledge. Such scientific principle holds any clinical regulations and guidelines to the highest standards. Hence, the objective of any clinical study is to address study questions in a manner that will ensure respect, safety, security and privacy of human subjects, and in the process will not thwart information and encourage falsification of data. There is also the implications in performing data management remotely, which may include, but are not limited to subject’s safety, security, privacy invasion and mishandling of data validation process. For instance, in the US, it is clear that the FDA holds the 21CFR part 11 (code of federal regulatory) to a higher standard by requiring companies to authenticate and maintain a high level of confidentiality on electronic clinical data mining (Prokscha, 2012). Nonetheless, there is a great deal of

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