The development of a good clinical research database is the epitome of valid scientific data collection and management. Good scientific data starts with an unbiased state of mind or a sound scientific hypothesis which will assume that all things equal, a null hypothesis is valid until proven otherwise. Thus, null hypothesis assumes no significant difference between a given control group and the experimental group being tested in any given experimental design (Dombey, Kelly, Markel, & Venable, 2012). Hence, the integration of research database design professionals into the process of protocol development in a clinical study is very essential to getting a reliable and evaluable data. Clinical trial data may be deemed incomplete and unreliable if important key research experts or professionals are not involved during the early part of the research database development. The lack or omission of the key variables from research experts in capturing the accurate data and applicable research logic or rationale for the research question could ruin the validity of a clinical research (Dombey et al., 2012). Clearly in any research, what is put in is what gets out depending on the query or logic applied to any database. Therefore, research database professionals must have full knowledge of the intent of the research question in order to generate a reasonable and valid program that will address the scientific need of the research in question (Dombey et al., 2012).

Electronic data capture (EDC) is the most efficient and significant way in minimizing cost associated with a clinical research and enhance the quality of regulatory submission time (Miller, 2009) . It promises higher rate of productivity, reliability, quality and validity to clinical research products (Bioclinica. 2012). Among other things the EDC promises include but are not limited to an outstanding fast data capture performance under any conditions, high level of interoperability, globalization of data, real-time metric systems, and it is a user friendly integrated system (Bioclinica. 2012). On the other hand, just like every other thing have their disadvantages; one major disadvantage of EDC is that enormous volume of shared invaluable data is at risk should the system compromised by unauthorized personnel (Shoo, & Bhatt, 2003). The level of an electronic database safety and security from intruders in protecting personal or organizational medical data is dependent on the level of encrypted security of the system and the level of restrictions allowed by authorized personnel to the system (Chadwick, Nonemaker, & Bien, 2002). Ideally, electronic data system may not be fully protected, or full proof from active intruders but high level and active encryption deter introducers. Most importantly, the need for electronic signature in the EDC system is an acknowledgement to any stated disclaimer to further authenticate the information provided was accurate.

References

Bioclinica. (2012).  In need of a functional and reliable EDC solution for your clinical trial data?   Retrieve from http://info.bioclinica.com/edc-form?pi_ad_id=5879323570&gclid=CP6dg-bEz7A CFccBRQodnh_AZA.

Chadwick, B., Nonemaker, S., & Bien, M. (2002). Implementing electronic data capture. Applied Clinical Trials, 11(2), 36. Retrieved from  http://ezp.waldenulibrary.org/login?url=http ://search. ebscohost.com/login.aspx?direct=true&db=a9h&AN=60773 12&site=ehost-live&scope=site.

Dombey, S., Kelly, M., Markel, D., & Venable, T. (2012).  Data Collection, Data Management, and Record Keeping. Retrieve from https://class.waldenu.edu/webapps/portal/frameset. jsp?tab _tab_group_id=_2_1&url=%2Fwebapps%2Fblackboard%2Fexecute%2Flaunch er%3Ftype%3DCourse%26id%3D_552454_1%26url%3D.

Donovan, H. (2007). EHR & EDC: Tomorrow’s technology today. Applied Clinical Trials, 16(2), 54–62. Retrieved from http://ezp.waldenulibrary.org/login?url=http://search .Ebscoho st.com/login.aspx?direct=true&db=a9h&AN=24041309&site=ehost-live&scope=site.

Miller, C. (2009).  Medical Imaging and Electronic Data Capture in Clinical Trials: the Future Paradigm. Bioclinica. Retrieve from http://www.bioclinica.com/News-and-Events/in-the-news/medical-imaging-and-electronic-data-capture-in-clinical-trials-the-future-paradigm/.

Shoo, U., & Bhatt, A. (2003). Electronic data capture (EDC): A new mantra for clinical trials. Quality Assurance, 10, 3/4, 117-121. Retrived from http://ezp.waldenulibrary.org/log in?url= http://search.ebscohost.com/login.aspx?direct=true&db=bth&AN=1563146 0&site =eds-live &scope=site