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This paper is based on the data storage which has been in existence and usage in the field of Medicine for centuries. The information has been used to capture, record and transmit clinical records in the field. However, with the technological advancement, the demand for quality increases. People are using electronics everywhere including clinical research. This paper suggests that Innovative Electronic Data Capture will make paper trial obsolete in clinical research.
Electronica data capture is more efficient, faster and quicker to generate and share, and can be shared over many systems at the same time when it is generated. It can also allow sharing of clinical data over Internet and bit is never indefensible to human errors like human data entry on paper.
Nevertheless, the electronic data capture may offer some minimal challenges which include things like electronic data hacking and unsupervised access to data or vandalism, but this can be eliminated through establishing proper policies and using protocols.
Research Electronic Data Capture which is also called in short “the Redcap” or just electronic data capture (EDC) as described above, is a browser-based workflow methodology for designing clinical research work databases mostly. It is more or less a kind of software system that facilitates the research recording and translation of data into another form; it makes metadata by Electronic Data Capture software solution. The system was designed by a student having taken study on Informatics at the VanderbiltUniversity; his personal thought was to solve the challenges of data storage experienced in the most medical research institutions. The system was to help them to use electronic data bases in managing data. This system is mainly used in the medical research cycles or other academic researchers across the world. Researches projected that the number of users may just increase due to the identified usefulness of the system (Miller, et. al., 2010).
There is a number of problems associated with paper-based source documents. Paper- based source documents cause many issues, for example, too many papers charts, inconsistency and illegible writing. A situation where a clinical researcher wants to collect data in a far research station in the field, the researcher has to take time for rerecording his observations on a piece of paper and sending to the central offices. So, one clinical officer alone may generate a lot of paper materials. If they are many there would be a large volume of work. Besides paper work recordings, the electronic recordings of clinical research trials have a formulated programme and order of data formatting and storage, that leads to consistency. Papers entries may not to show enough consistency in entries as each researcher will have to record according to the best way of his perceiving of a certain observation. Another problem with paper work may be based on illegibility of writing; this might occur because of many people have different hand-writing styles, which can be unreadable to others (Willa et. al., 2002).
Another problem is associated with the paper data collections and is that in paper-based data collection clinical trials data will not be available on display immediately as soon as data entered. The data has to be loaded into systems and sent back to a principal research investigator in the central office for data analysis before it will be interoperated and used (Hance, 2009). Data is entered into the Clinical Data Management System and the system (CDMS) analyses and generates data independently. This process from generation of the data to the use is so long in paper-based data entries and this usually delays the process, unlike the electronic systems, where the data is ready for use immediately as it is generate (Turner & Rick, 2010).
Besides the above two challenges, the paper trial for clinical researches is costly and time-consuming in terms of workload and record retention for both investigators and sponsors. The workload increases as the field investigators have to do the extra work of filling in the findings on paper. This takes much time, is consuming and cost, the papers cannot be recycled or reused. So, you have to buy new papers for new entries (Willa et al., 2002). This is not normally the case in electronic data entries, once you have the machine equipped with appropriate software to capture data, it will automatically generate the output to be also used again all over (Michael et. al., 2009).
The thesis statement for this paper is formulated as the following: Innovative Electronic Data Capture will make paper trials obsolete in clinical research. The argument in this paper is to establish why the Electronic data captures will replace the paper work and why the writer is in support to it.
Problems/Obstacles (arguments in favor of the thesis)
At the time of modern technology development the mode of creating things seems to be changing towards to the current technological advances. The field of medicine is equally up-to-date with the technology, and does not want to be left behind. That is why the clinical data collections captures are going digital (Michael et. al., 2009). The collected data regarding researches in the field by an investigator can be shared through electronic data capture systems. The reason for clinical data capture is likely going to replace paper trials because it’s the latest technology in the field of clinical data collection and storage. Many governments are urging their physicians and medical practitioners to adopt this method in their research, the USA have being the lead. Some of the technologies that are in use in many countries include Medidata RAVE, which is a system that can capture data even from a telephone interview of patients; they can also be linked to external systems that allows the data to be shared by many people (David, 2009).
Secondly, this system is faster and more efficient data capture; it’s also a speedy process of data storage and sharing. It involves the use of web-based data capture system. These systems are designed with specialized coding to allow wrongly captured data to be detected and even errors (Wiley, 2007). The captured data can be passed through computerized software connected to a medical dictionary that will just detect medical grammar. Computer programs such as MedLEE (3), rbChart (4) can convert data into structured languages, or standard vocabularies and terminologies (like UMLS, ICD, and SNOMED-CT). It’s more effectual than paper entries (Willa et. al., 2002). More data analysis can be achieved using this electronic system as against the papers. So, if it’s so efficient why can’t we adopt it?
The electronic systems will save the burden of copying for many clinical research scientists, and also typing, dictation and many other obsolete tasks that are always involved in the paper systems. This would be their advantages, no time consuming activities. Possibly, it causes they can do the huge amount of work in the short period of time (Chin & Bairu, 2011). The organization that deals in the sale of this software (the Redcap) for electronic data capture indicated that by 2008. It had a network of user totaling to more than 250 institutional partners which are in the wider network of users. There are also more than 20,000 end-users employing this noble software in about or just slightly more than 30,000 studies providing in the field of medical research (Willa et. al., 2002).
Problems/Obstacles (arguments opposed to the thesis)
Just like any form of change and new advances, the electronic data captures are facing variety of challenges and oppositions. As a new technology, there is a fear that with increasing of computer usage among many people. It can lead to security unconformity such as data leakages to the unintended persons. Computer or internet hacking is the one of threats that oppose this development. People say, that an internet hacking occurs the security of clinical data stored may be at the risk, anyone can access it and this could lead to misuse of information. In this case, the paper-based work still holds promises since they are not subject to vandalism in greater degree (McFadden, 2007).
There are also many people who say that as much as this method may be faster and more convenient, it may not be useful to many of the countries, especially developing countries. They may not be in a position to acquire the instruments that use of these systems more drives to avail it to every respective investigator on doing research in the field. They look at it in terms of the cost of technology adoption and to such groups of people they advocate for continued use of papers for keeping records.
There are more other arguments that are put against the electronic data capture and storage in the clinical research areas. For example, there are those who say that elimination of paper data recording may lead to redundancy and joblessness. Reducing the workload for the clinical researchers will lead to loss of job for those who were already engaged in the activity since much of the work will be done by machinery (Michael et. al., 2009).
Proposed Solutions (rebuttals to opposing arguments)
The future for electronic data capture systems is still very bright irrespective according to the opposing views. Certain things can be done to ensure that the fears mentioned above can be addressed even as the sustainable use of electronic sources. The use of Layer (SSL) technology in transmitting data over the Internet has been evaluated as the best solution for data insecurity, it ensures privacy and additional message integrity, and the EDC system should always use Secure Sockets. All user of the technology should have a logo in address to ensure that only authorised access is allowed. For as long as standard operating procedures are followed, and the servers and network configured securely, there is no threat of data hacking. A protocol has been developed to ensure the security and protection of the internet data resources (Miller et. al., 2010).
The cost of adoption of the technology may be quite high, especially to developing countries. But the long-term benefits are worthy. After all, it is economically viable. It is considered to be viable even in terms of the cost of papers, from the point of view of environmental conservation (Chin & Bairu, 2011).
There is no job that is lost by the inception of technology in any systems, especially when this is viewed from the macroeconomic scale. There is only a shift of professionalism. The most people, who get benefits, are those who accept changes, who go for skill upgrades. If paper work doesn’t work anymore, you are trained to use the electronic system instead and you will not lose the job.
In conclusion, the electronic data capture and storage appears to be the best way for clinical research providing. It bears a brilliant future for efficient research in the area of clinical health. The technology was developed by student on Informatics, whose main interest was to support clinical institutions and researchers to manage their data in more collaborated way. It was principally to integrate and encourage networking among institutions that would buy and support the vendors of software as well. The idea was that as the users buy the staff, the sellers were also to benefit anyway. The electronic data capture method has been identified as efficient and tested in major developed countries.
There is a clear sign that clinical data capture is likely to replace paper trials. This is because it’s the latest technology in the field of clinical data collection and storage. It makes the work more effective, easier and quicker. The electronic systems will save for many clinical research scientists the burden of copying, typing, dictation and many other obsolete tasks that are always involved in the paper systems.
Paper trails for clinical researches are cost and time-consuming in terms of workload and record retention for both investigators and sponsors. The workload increases as the field investigators have to do the extra work of witting and filling the findings on papers. This takes too much time. The papers cannot be recycled or reused, so, you have to buy new papers for new entries.
The only significant challenge with electronic data storage and capture that is used in its opposition is that electronic data storage is a subject to information leakages and vandalism. Some of the observed challenges like computer or internet hacking are proposed by the most of the opponents against this development. They stated that the internet hacking occurs and the clinical data storage may be at risk: anyone can access it and this could lead to misuse of information. Other problems that people associated with this system include the high cost of adoption of the technology, especially in developing countries and also the risk of the lost of job by advancement of technology.
However, the above observed problems with electronic data capture can be conquered; policy measure can be put in place to secure against data loss and insecurity. For example, the use of Layer (SSL) technology in data transmission over the Internet has been evaluated as the best solution for data insecurity, it ensures privacy and additional message integrity, and the EDC system should always use Secure Sockets. All users of the technology should have a logo in address to ensure that only authorised access is allowed. For as long as standard operating procedures are followed, and the network and servers are configured securely, there can be no threat of data hacking. Developing countries should also look at the long-term benefits of the technology instead of just seeing it as a costly venture. Again, it has been realised that there is no job that is lost by advancement of technology anywhere. There is only a sign of professionalism; the most people who benefit are those who accept to change with the change, those who go for skill upgrades. If paper work doesn’t work anymore, you are trained to use the electronic system instead and you will not lose the job.
The message to be stated in this research paper is that the electronic data capture system for clinical researchers is better than paper data trails; it has been tested and found out to be more convenient, faster, easier and reliable then paper systems. It is far more environmental friendly.