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 concern that remote data control or electronic system may encourage falsification of data if limited access by “role” is not instituted in the new technology system or electronic data capture (EDC). Moreover, in fostering high data integrity in a clinical study, 21CFRpart11 section 11.10 addresses the importance of requiring limited access, tracking and holding users accountable to the database access (Stein, 2006). Computer breach is the biggest threat facing electronic data system, which may leave subject’s private and personal information vulnerable for attack and duplication. The concern for electronic breach drove the FDA and other regulatory agencies in recommending periodical change and restriction of users (clinical professionals) password via the appropriate information technology (IT) team within the clinical organization, in question (Prokscha, 2012).

Another danger of remote access is that remote “Log in” may allow determine hackers access to subjects’ private information. Also, breached access to remote data, could be an easy target for data falsification and product accountability. Perhaps, in an attempt to avoid possible falsification of data, many company’s IT group installs automatic disconnect or lock system (Prokscha, 2012). However, the safety and security measures may not completely solve the breaching issue, in a situation where the system is breached.

An electronic breach allows massive data access and subject’s personal information to unknown hackers. Unlike a paper system, data compromise is possible only with limited number of data and subject’s information at any given time. Nonetheless, remote data system has shown to increase productivity, speed up data analysis, reduce cost and enhance clinical study process with regulatory agencies. Out of these possible case scenarios, perhaps, the best practice is to handle each situation on a case-by-case basis, and based on the company’s capacity, needs and study type, in question. Unfortunately, there is no substitute for site inspection; thus, auditors or monitoring team may not efficiently inspect the standards and quality of clinical research sites or a sites’ data system validation via remote system without high risk of costly errors.

Reference

Stein, T. (2006). The computer system risk management and validation life cycle. Retrieved fromhttp://books.google.com/books?id=Lnmok6CybyUC&pg=PA45&lpg=PA45&dq =21cfr+part+11+section11.10&source=bl&ots=2I9MHyHDyd&sig=BJZSuHaJZh TehjaA6pDkvuGGlps&hl=en&sa=X&ei=XW6lUJLMHarvigLVs4CgCw&ved=0CHAQ6AEwCA#v=onepage&q=21cfr%20part%2011%20section11.10&f=false

Prokscha, S. (2012). Practical guide to clinical data management (3rd ed.). Boca Raton, FL: CRC/Taylor & Francis.