There are many reasons why paper-based case report forms (CRFs) are so frustrating. They are messy, time-consuming, and, most importantly, a pain to work with. There’s nothing worse than reviewing a bunch of research papers only to realize that some information is incomplete or disorganized.
The world we live in is all about technology. Almost every task that you do is automated. A big percentage of the world’s population either owns or can access a gadget or smartphone. With this in mind, it makes you wonder why researchers still choose paper-based CRFs rather than electronic CRFs (eCRFs).
An electronic data capture (EDC) replaces the paper-based collection of data. These automated systems are created for clinical data collection in an electronic setup. They improve the data collection, remove double data input, and hasten research analysis and outcomes.
There are many ways that paper-based CRFs can be replaced with digital ones. SDTM domains (Study Data Tabulation Model domains) are the most common domains of health information. These are a set of standardized terminologies that can be used to describe data consistently.
Paper-based CRFs are outdated and inefficient. They can be replaced with a more efficient form of data collection. Here’s why:
- Time
Paper-based CRFs are tedious and time-consuming to fill out. After the data has been filled out on paper, the next step is to input the information into a database. This is a taxing exercise and may take a long time to complete. Before distributing the data, it must be analyzed and reviewed.
People can save time if they use eCRFs. The benefits of electronic CRFs include faster data entry, automatic error detection, and more accurate data collection. Plus, data can be distributed instantly with accuracy. This will allow researchers to cooperate in real time. Besides, with eCRFs, researchers can quickly evaluate and assess their data, create instant reports, and export data.
If many users need access to your paper-based CRF, this can become challenging and inconvenient because there will be a lot of exchanges of hands, and some information might get lost in the process. This can also lead to delays in processing requests which may affect your organization’s productivity levels.
- Cost
Paper-based CRFs are expensive to produce, distribute, and maintain. The costs of these processes can quickly add up. Paper-based CRFs require a lot of paper, which is a dwindling resource.
The cost of maintaining a paper-based system is high. This is because of the high volume of documents that must be printed, maintained, processed, and archived.
Paper-based CRFs can also be costly and inefficient due to the time they take to input information. A paper-based system requires more time, money, and effort to run. Furthermore, they can be easily lost or destroyed by the environment or people who mishandle them. The cost of paper-based CRFs is one of the main reasons many people have given up on them in recent years. Using eCRFs is an innovative and cost-effective way to collect data.
- Security
When it comes to patient information, security and confidentiality are a priority. Paper-based CRFs are not as secure as they seem. They contain a lot of sensitive information that can be easily stolen. Plus, data can be compromised since it’s not safe. It can be tampered with, lost, or stolen.
It isn’t easy to maintain the confidentiality of the data. In some settings, paper-based CRFs are difficult for clinicians and patients to keep private and confidential. This is particularly true when used in public areas or shared with other care providers.
Clinical research sites should take steps to protect the confidentiality of patient data, including paperwork. By using privacy folders, you can ensure that your paperwork is not accessible without your consent.
- GCP And FDA Compliance
The FDA (Food and Drug Administration) has a set of guidelines for the industry to follow, and GCP (Good Clinical Practice) is a set of guidelines that research organizations follow. Paper-based CRFs are not compliant with these guidelines. As such, paper-based CRFs are becoming more and more obsolete.
The GCP compliance is designed to ensure that clinical research is conducted in a way that meets ethical standards and regulations. FDA compliance ensures that the products being tested are safe for consumption by humans.
In order to achieve compliance, paper-based CRFs need to be digitized. The digitization process starts with scanning the paper-based CRF and converting it into an electronic form. Once it is in electronic form, it can be uploaded onto a server and shared with other stakeholders in the project. This process provides better data quality, faster data entry and secured data management. This approach is compliant with FDA and GCP guidelines.
- Multi-Center Collaboration
Paper-based CRFs are a problem for multi-center collaborations. They are not only time-consuming, but they also require a lot of resources to be printed and distributed.
Paper-based CRFs are not easy to share and often require a lot of time to be scanned and uploaded. It is also hard to track who has seen what and who needs to sign off on the paper form.
In contrast, electronic CRFs make it easier for multi-center collaborations. Data can be shared easily with different stakeholders and can be monitored in real time.
Paper-based CRFs are not ideal when collaborating with people from different centers or departments. This is because paper forms cannot be shared easily, making it difficult to get feedback from a wide range of people quickly and efficiently. They also take a lot of time to scan, upload, share, and track who has seen what. It also needs approval from someone in charge, which can lead to delays in research progress and increased administrative costs for the researcher.
- Systems That Can Be Used Without The Internet
The internet is a very crucial resource for conducting research. In some settings, however, internet access is not available. With the use of paper-based CRFs or on-site servers, researchers can still gather data in these settings. In this case, both options can be costly.
For this reason, electronic capture data providers have designed ways to support offline data collection. They have developed Android and iOS-like systems that can be used with or without the internet. This has enabled data collection in areas with poor or unstable internet connectivity. The data collected can later be synchronized without compromising its accuracy.
Recap
In conclusion, paper-based or handwritten CRFs are inferior to their digital counterparts, starting with the readability, ease, and accuracy of data capture for clinicians and patients. Paper-based CRFs are a hassle and expensive, and data entry is inefficient and often inaccurate. It’s time for researchers and healthcare professionals to ditch paper-based CRFs for easier and more efficient digital recording tools.
