Why Sites Prefer Prelude EDC – Part 2 – eCRFs Can Look Just Like Paper
By Editorial Team on January 5, 2022
We consistently get feedback from our clients that their sites prefer working with Prelude EDC. When sites know they will be using a preferred EDC, they are more likely to participate in a study, are better at meeting enrollment objectives, and are more likely to adhere to protocol requirements. This three-part series explores some of the reasons sites prefer Prelude EDC (see Part 1). A major reason users prefer Prelude EDC is that eCRFs look the same as forms laid out in a protocol or on existing paper forms.
There are many moving parts that contribute to a site’s operation. These parts are the users who contribute to the collection and analysis of high-quality e-Clinical data. Let’s look at how all these moving parts benefit by using eCRFs that look just like paper forms.
Study Builders – Developing a data collection platform for an e-Clinical trial isn’t rocket science, but it is an underappreciated art form. Rather than requiring study builders to think about how to organize an eCRF, providing them with a tool that allows them to develop forms that look just like their paper equivalent makes their job easier and lets them perform faster.
Site Personnel – When eCRFs are laid out just like paper the data can be grouped together logically in a way that makes visual sense. This makes it easier to look at, understand, and more naturally enter data. For example, if there’s a table of physical exam body systems in the protocol (that includes the body system, normal/abnormal flags, a rationale for an abnormal observation, etc.) it’s better for the eCRF to be organized in a tabular fashion rather than using a vertical presentation with each data point on a separate row.
When busy site personnel are filling out forms that are laid out in a logical manner it makes them more likely to use the EDC as the source document rather than initially entering the data on familiar paper forms and transcribing it later – allowing them to take full advantage of real-time edit checks and avoid transcription errors.
Study Personnel – The tasks of Monitors, Project Managers, and Data Managers are all streamlined when eCRFs look like protocol/paper forms. It makes it easier for those personnel to locate and analyze critical data points – and to recognize when “something’s wrong” with the data. Early identification of data anomalies greatly increases study data integrity.
Biostatisticians – These users benefit from being able to look at the eCRF to logically see the context of fields in the study database. They aren’t always sure what the variable names mean, and the use of an annotated CRF on a form that’s laid out logically helps them understand the data.
Regulators – Sponsors/CROs know that if it’s hard for regulators to map study data to a protocol, it will take them longer to review submissions. This benefit is amplified when regulators such as the CVM are using the Remote Access program which gives them direct access to the online EDC system.
Why use an e-Clinical data capture system that limits eCRF layout to a single field on each line when your study could experience all the benefits above by using Prelude EDC?
Stay tuned for Part 3 where we explore the reasons why sites find Prelude EDC easy to navigate.