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Improving Data Quality In Clinical Research Studies With The Use Of Edcs

If theres an easier way of doing things, wouldnt you be interested to try electronic data capture? Traditionally, clinical trials were conducted manually. Information is first collected on paper and then filed away for later use. Doing things this way is a fairly effective technique, but it isnt without its flaws.

The biggest of which would be the fact that it is tedious and time-consuming; two things that our modern world rarely has time for when it comes to task management. This is where EDC enters the picture.

What is EDC?

Electronic data capture is basically a system which collects and organizes all of the data gathered during a clinical trial or research activity. It is one of the best eClinical solutions when it comes to planning, collecting, accessing, exchanging, editing and archiving any information collected during clinical trials. Learn more about EDC in this video:

Where paper records could take up a lot of physical space, through the use of EDCs you can have all the information you require in one place one that you can take with you wherever you go. Quite convenient, right? This is just one of the reasons as to why people are switching from paper records to something more digital.

Pros and Cons of a Clinical Data Management System

There is no such thing as the perfect software and in this case, there are pros and cons to using EDCs when it comes to collecting information. To keep this article unbiased, well tackle both the pros and the cons.

Positives:

- The biggest would be convenience. With just a few clicks, youll be able to sort through hundreds to even thousands of files to find the one you need. Many EDCs also come with search filters that would make navigating through your archive even easier. Just type in a keyword and youre good to go.

- Security is another priority. With clinical trial management software youll be able to set permission levels and filters when it comes to the actions a person can do whilst logged in. This is helpful especially if youre allowing access to more than just a few members of your team. Individual passwords can also be added to further enhance the security of your files. You can protect it from manipulation, from getting stolen and from any accidental deletions. Back-ups will provide you with an insurance against that.

- Make information exchanges easier and safer. These days, any file can be sent digitally and within seconds it can reach its intended destination. The same applies to any file saved within an EDC.

You can send it to any place in the world without worrying about costs or delays. Any edits made to the records would be reflected in real time as well, making it less troublesome for people who might be working on the same thing, but in two different places.

Negatives:

- The cost. EDCs arent the most affordable tools for this purpose, this is a fact. Whilst there are free versions of it available online, these have far less features than others and offer no form of customer support. If you want something thats fully functional, investing in one is your only option. HOWEVER, do consider the free versions for trial purposes.

- Learning curve. As most people wouldnt be familiar with how a clinical trial management system works, there will be a learning curve to overcome should you decide to switch to using one. Now, it isnt very difficult to comprehend and most people only require a few hours to get familiar with it.

However, people who have had no prior experience with using a similar system might need a bit more time to fully understand it. If youre prepared to make the necessary adjustments and give people ample time to learn it then this shouldnt be that big of an issue.

Factors to Consider When Choosing Clinical Data Solutions:

- Hosting

- User Support

- Costs

- Regulatory Requirements

All of these things can affect how successfully you can implement the system. Theres also the human factor to consider. How familiar is the employee when it comes to using it? Remember, not everyone has the right attitude or management skills that would complement with the use of an EDC.

Should You Invest in a Clinical Trial Software?

The general answer would be: YES. It is an efficient tool for streamlining the task at hand and it serves its purpose well. True, some people do harbor certain doubts when it comes to its useprimarily concerns about accuracy, security and its overall costs. So it all boils down to your preferences and needs. If it meets all the prerequisites you have and youre prepared to spend some of your resources on it then there shouldnt be anything stopping you from giving it a try.

References:

http://www.appliedclinicaltrialsonline.com/electronic-data-capture-clinical-trials

https://www.cdisc.org/system/files/all/reference_material/application/pdf/bei26kushsup.pdf

http://forteresearch.com/news/beginners-guide-electronic-data-capture-edc-system/

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