What are Electronic Clinical Trials?
Electronic clinical trials are an indispensable part of a clinical trials management system. An electronic clinical trial can be perceived as an electronic system with which to track the document the entire path of a clinical trial. That is, an electronic clinical trial is an automated system with which to keep track of the full history and trail of a clinical trial.
This history path, aliased as the clinical trial management system (CTMS), is a rather large system. The CTMS is used over long periods of time and can be located over several places, many times across national boundaries. Electronic clinical trials have developed out of the need to systematize and accelerate the whole set of activities with respect to maintaining and overseeing clinical trial routes.
It goes without saying that in areas in which the incidence of clinical trials is high, namely the pharmaceutical and biotechnology industries; electronic clinical trials are most common.
Characteristics of electronic clinical trials
Electronic clinical trials are characterized by the following features:
- Their fundamental function is to maintain and manage system planning
- Helping the healthcare or biotech organization with its performance and reporting functions is another core aspect of electronic clinical trials
- In order to help the company keep track of important stages and milestones of its clinical trial work; electronic clinical trials incorporate the contact information of the clinical trial participants.
Advantages of electronic clinical trials
The electronic TMF (eTMF) systems enable faster and a more secure method by which to share all of the clinical study documents. It comes with a few advantages over traditional paper documentation in the following ways:
- There is a vastly reduced chance of losing TMFs or having them destroyed
- Being electronic in nature; eTMFs are much more easily available and accessible in any clinical site anywhere in the globe in real time. This is incalculably easier than with paper records.
Drawbacks of electronic clinical trials
While electronic clinical trials come with their distinct advantages; they are not without concerns. Firstly, security is a big issue. One wrong code can cause mayhem in an otherwise secure setting. Secondly, file naming can be an issue, because it is the same file name that is given all along the chain. Improper naming of files somewhere in the trail can result in problems.
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