If you need to create an eCRF for your clinical study, let me give you a piece of advice: use an eCRF that allows you to design and configure it through a visual editor.
In this article I will explain to you why?
First advantage: Not depending on people who can code.
I don’t know if you have ever had to depend on someone with computer coding knowledge.
If you haven’t, congratulations ;-)
Profiles with coding knowledge are highly demanded and there are more job opportunities for them. This is not a contextual phenomenon, it has been increasingly happening for the last 20 years.
Everyday more people with coding skills are needed. And to be honest, it doesn’t look like it will change any time soon, quite the contrary.
What does all of that have to do with an eCRF, you may ask, right?
Simple, some eCRF can only be configured or modified by people who can code.
There are even configurable eCRF that contain some parts like the configuration of “edit checks” for which coding knowledge is required since these elements can only be configured by code in a specific programming language.
This dependence becomes a weak and vulnerable point for our clinical studies because both creation and modifications of the eCRF depend on people who are usually heavily work loaded and hard to replace or train.
Second advantage: Shorter implementation and changes times.
If I want to create an eCRF for a clinical study and I want to do it in little time, it will be harder to do so if coding skills are necessary to perform a given amount of tasks.
This will cost more time and will make it easier for contingencies to appear.
If the eCRF configuration tool is a visual tool and no coding skills are required, it will be much easier and faster to build the eCRF. Besides, we will be following what is known as an agile methodology, that means we create a version and allow the decision makers (Sponsors) to assess the eCRF and propose changes based on a real and functional version of it.
These review cycles are faster and achievable if the eCRF configuration tool does not have the added complexity of requiring coding skills, since more personnel will have the capability of making changes.
As a final result we have an eCRF that is to the liking of the decision maker (Sponsor) without incurring a high cost, compared to that of having to perform all those changes through a programmer.
Third advantage: Simplification of the eCRF validation processes.
In order to meet the regulatory requirements, it is necessary to validate that the eCRF meets the requirements indicated in the study’s protocol.
Such a task is easier to perform when a configurable environment is used than when the eCRF is programmed. In a configurable environment, for instance, according to the GAMP5 classification the system would be a category 4 but a programmed eCRF would be category 5. Category 5 systems are more complicated to validate and it takes longer to do it.
Besides that, if we work with a visual eCRF that controls the design validation, we would be simplifying the task of validating the system.
An automatic system for the validation of the eCRF’s design checks that if, for instance, a field is eliminated from the eCRF, that there is no “edit check” using that deleted field.
This way, making changes becomes faster and more secure, because the system itself validates that there are no inconsistencies in the configuration of the eCRF.
ShareCRF’s visual editor.
ShareCRF is equipped with a visual editor that allows to configure the entire eCRF visually (through drag and drop tools) with no need to code whatsoever.
The visual editor contains an automatic validation system that allows it to detect errors or inconsistencies in the configuration while it is being edited. This saves a lot of time and helps avoid many of the errors in the process of configuring the eCRF.
Besides, ShareCRF is also equipped with an advanced test environment, which allows to test all changes and modifications in the configuration of the study in a different environment than the production environment of the study and therefore without interrupting the users and without putting the real data of the study in jeopardy.