We have heard from researchers that paper forms can be time-consuming with many errors that affect data accuracy, completeness and consistency in medical research. Today’s world is all about technology in everything we do, touch or feel. According to GSMA, 5 billion people globally have mobile devices today, and this is expected to reach approximately 6 billion by 2025. What this indicates is that about two-thirds of the world population own or have access to a smartphone. However, why do researchers still opt for paper Case Report Forms (CRFs) instead of electronic CRFs?
Electronic data capture (EDC) software is a computerized system designed for the collection of clinical data in electronic format. EDC replaces the traditional paper-based data collection methodology to improve data quality, eliminate double data entry and expedite research analysis and results.
Although EDC systems for eCRFs have been around since the 90s, more than 50% of regulated researchers still use paper forms because they believe its cheaper and easier to use. The number is higher (up to 80%) if we include non-regulated studies. This is likely because there’s no need for IT training when using paper forms and of course, the widespread assumption that the cost of printing paper is not as high as purchasing technology devices.
Every researcher needs to consider the following factors before collecting their data:
Since money is a vital influencer of everything around us, it's human nature to choose an option that saves you some. At a glance, paper CRFs seem cheaper since you don’t need license fees, technical training and the expense of just printing forms doesn’t sound so expensive. But the real costs are associated with the inaccuracy and low quality of data linked to paper data collection. Distribution, resolving queries, data cleaning, site visits, filing and storing paper-based data can be costly, time-consuming and minimized or even evitable when a study is run using EDC.
Once data is collected on paper, manual data entry into a database follows. Now, this is a long process that can be tiring and may take months to complete. And it doesn’t stop here! The data must still be analyzed and reviewed before dissemination. A lot of time can be saved when using EDC by minimizing site monitoring, skipping the double data entry process and readability barrier. The data can also be shared immediately with a high level of accuracy enabling researchers to collaborate in real time. Researchers can also analyze their data faster as eCRFs can create real-time reports and export data to statistical tools like SPSS. This is changing, and nowadays, EDC is becoming easier to use without any programming knowledge needed. Teamscope’s point and click interface enable you to build your eCRFs faster, easier and ensures only valid data is entered without any technical training.
Patient data must be secure and confidential. This is research 101. With paper data capture, this can be compromised especially during data transfer. Since it requires manual transportation, paper CRFs can easily be accessed by parties that not supposed to. EDC systems like Teamscope offer strong encryption at all moments and daily data backups.
With clinical data collection, it is mandatory to follow some standards and regulations. Both paper and electronic data capture must comply with Good Clinical Practice (GCP) and FDA. Data collected must be valid. Achieving valid data is only possible if it's gathered according to your study design. This is difficult with paper CRFs making the data highly erroneous. But EDC eliminates invalid data by alerting the enumerator immediately leaving only valid and reliable data for use. Another factor to pay attention is how to minimize the exposure of confidentiality and sensitive information, and this is achieved by creating granular permissions to define who has access to our study and for what task. This way you can maintain full accountability for your team. Also, data can be accessed by only approved users. Use of passwords, encryption and off-site storage of data ensures that research data cannot be accessed by unauthorized people. This is not the case with paper CRFs which most of the time are either locked in a cabinet with a padlock, or we see them lying somewhere in the office.
We gather data to answer research questions, test hypotheses and analyze results. For all this to be of good quality, feedback is necessary. Why? Because two heads are better than one. Feedback helps improve situations, boost motivation and above all, is a tool for learning. For you to receive feedback, one must share the information they have with others. Hence, collaboration across research teams is vital.
Paper CRFs delay feedback since it might take weeks to months to share data and collaborate with team members. With EDC, data is synchronized allowing multiple research sites to collaborate in real-time and assure everyone is updated and on the same page. What does this mean? Whenever a team member adds a data entry or modifies previously stored record, that change synchronizes for everyone. This way, feedback is received and acted upon faster than with paper CRFs.
Why is multi-centre collaboration beneficial in research?
One major concern about using cloud-based EDC is they require an internet connection. Sites with poor or unstable internet have to make the decision of paper or on-site servers, both are costly. Because of this worry, EDC providers are now extending their systems as Android and iOS applications to support offline data collection which means data can be collected and stored without the need for internet and synchronized once you gain a connection. Whether you are conducting a clinical trial at a hospital or examining patients in a remote village, mobile EDC ’s like Teamscope now allow you to work wherever you need.
No one can oppose the fact that we live in a digital world. Researchers have to be versatile and ready to embrace change. Research is an expensive venture and using EDC makes it less costly and laborious than paper data capture. So what are you waiting for? It’s time for researchers to ditch paper CRFs and migrate to EDC; a less costly option that enables you to collect valid and quality data which can be shared with multiple research teams safely, timely and smoothly.
Teamscope is an easy-to-use, affordable and offline-enabled mobile platform for Electronic Data Capture (EDC) in medical and field research.
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I'm a business development specialist Teamscope. I enjoy helping our users do more and better clinical research. I'm a non-typical medical doctor and an above average board game fanatic.