Data is essential to medical studies, and billions of dollars are spent on it. To collect data for such medical studies, using an electronic case report form (eCRF) becomes vital. eCRF is a digital questionnaire that provides results about research participants and clinical trials to help biostatisticians come up with conclusions.
eCRF software can give many benefits. First, it allows data sharing to all stakeholders over systems. Second, it enables transparency by providing real-time access to data. Lastly, it can provide more secure study participant data.
Because of its benefits, there are some crucial practices that you can make to ensure that the eCRF system is efficient for your clinical trials. If you want to know them, you can continue reading this article.
- Be Compliant
eCRF collects a lot of patient data. However, a scenario where such patient data gets accessed by an unreputable individual can be severe. Thus, security measures become necessary.
Various regulations guide the collection and handling of personal data, and some of them are industry-specific while others are general. The principal regulations that guide data collection and handling are the Health Insurance Portability and Accountability Act (HIPPA) and General Data Protection Regulation (GDPR).
These regulations cover the data you’ll need in the clinical trial, aspects regarding proper disclosure to the patient on how you’ll use the data and the need for a safe system that allows for secure data storage.
In addition, Clinical Data Acquisitions Standards Harmonization (CDASH) is a standard implemented in Europe, the United States, and Japan. It also establishes the guidelines for making eCRF. It ensures that data collection structures and formats allow more transparency in front of regulators and others who oversee the data review. You can read full article here to learn about them.
- Use Edit Checks To Cleanse Data
Having a case report form out of paper doesn’t allow for data checking as it is entered. However, eCRF has edit checks that cleanse data during its entry to notice issues when they’re mostly easy to correct. This is the advantage of eCRF systems.
Concerning data entry, edit checks can give a history of traceability of its issues. This assists in not only making data cleansing less complex but also helps to make medical studies much better as time goes on. When the study administrators oversee how data entry is doing, they can make corrections in the edit checks.
As edit checks allow for data quality improvement, there are many other benefits that it can provide regarding eCRF. It allows for a real-time response for site staff as they enter data and gives data managers the chance to monitor and concentrate more on complicated review activities. Lastly, it allows for early resolution of electronic review and data discrepancies.
To note, there are various types of edit checks to choose from, but most situations will probably make use of standard or protocol-specific edit checks. Likewise, there are essential things to consider when using them, such as:
- Standard Edit Checks: You should test the form template and reuse the form on most protocols if you can program ten standard checks in such a form template. Also, use standard checks to define your standard library of form templates and edit checks that address common data entry errors.
- Protocol-Specific Edit Checks: You can sometimes use protocol-specific edit checks, particularly for unique protocol procedures and critical data points. Moreover, protocol eligibility criteria such as age differ from protocol to protocol and may need to be made as protocol-specific checks.
Altogether, editing checks can help your data analysis team ease their tasks. As such, they can have more time to concentrate on data interpretation and analysis, which in the end, can accelerate the clinical trial.
- Apply Simplicity
Simplicity is vital in filling out an electronic form. You must ensure that your patients won’t become overwhelmed by the entire procedure and fill in the correct information.
To maintain simplicity, you can use simple language that your patient will have no problem understanding. This prevents distorted information during interpretation and ensures on-point and valuable data.
Another way to achieve simplicity is to arrange the forms properly without having excessive information on a given page. This is to avoid any concerns about printing costs by having multiple pages.
Likewise, you can also use medium and large fonts to make the form more readable. However, don’t exaggerate the size of the fonts that you end up with many pages that your patients need to fill.
Overall, simplicity leads to a better user experience, an ingredient for accurate clinical trial data.
Conclusion
Data is vital for medical trials, and a lot of money is spent on it. Because it’s critical, one way to collect it is through eCRF. There are a lot of benefits that eCRF can give, making it ideal for clinical trials. Because it’s suitable for clinical trials, there are some practices to make it more efficient, and you can find some of the above.
Altogether, remember these practices to make your eCRF system more efficient, which in the end, helps to have a successful clinical trial.
