If you have decided to use an EDC or an electronic CRF (eCRF) to collect data in your clinical trial, it is important to know what are some of the most important characteristics that you should keep in mind when choosing one.
In this article we will analyze 3 main features (according to us) that can help you select a good EDC/eCRF for your clinical trials.
Let’s start with the first one:
1º Great user experience
In a study there are a lot of people with different profiles involved in the use of the eCRF/EDC. Usually there are several sites, investigators, coordinators, data entry personnel, monitors, data managers, project managers, etc. And for further complication most of these people are involved in more than one project so their work load is usually very high.
Imagine these users utilizing different EDC/eCRFs in different clinical studies on a daily basis, besides other applications that the rest of the people use for their work. It, of course, does not look simple and those who have been in that situation know it for sure.
That is precisely why if the selected eCRF/EDC does not provide a great user experience you will have a huge number of people involved in the study upset and unhappy, and besides, issues in the research will emerge such as:
- Delays in deadlines
- Lack of collaboration from the users in the monitoring processes.
- Errors due to the complexity of the use of the eCRF/EDC.
But, what is user experience?
The factors on which people base their opinions to define a great user experience are not always the same, but in general it is estimated that a great user experience is defined by the following factors:
- Ease of use
So if you want the user to have a great experience, the secret is to improve those factores to the best possible in the electronic CRF.
Ease of use
We all prefer things that are easy to use.
Well, maybe not all (there are always people that are different), but the majority of us do.
When we talk about ease of use in an eCRF, the most important aspects to be valued are that the eCRF/EDC is intuitive and easy to understand. Doing so we can make training and education in the eCRF simpler and faster. Besides, retraining will not be necessary as it is with other less intuitive and harder to use eCRFs.
For instance, if access to a patient’s form is complicated and not intuitive, or it is hard to move from one form to another within a patient, users who will use the forms to introduce information or to review it will face a greater level of difficulty to do so and therefore their user experience will be worse.
In the case of users in charge of designing the eCRF it will not be the same to add the forms by uploading the forms in a specifically formatted file or by having coding skills to be able to add certain functionalities to the eCRF, than to be able to visually design the eCRF with no coding skills whatsoever.
Utility is a factor that lets us know how useful the eCRF is for its users, or how much it can do for them.
Therefore, it makes sense to think that an eCRF that offers many functionalities like: review and monitoring tools, queries management, direct data input by the patients (ePRO), integrated randomization, etc., will have greater utility than one that offers only the functionality of recording and storing data.
But, be careful! This is important: Greater utility does not guarantee a better user experience.
More functionalities, if they are not easy to use or do not improve the efficiency of the process (the other two factors involved in user experience), will not provide a better user experience and can actually have the opposite effect.
What are some features that can be useful in an eCRF?
The list can be infinite, and each eCRF will have more or less functionalities. Some of those functionalities can be the following:
- An automatic Audit Trail system.
- A tracking system of reviewed information.
- Electronic signature.
- Real time data export in different formats.
- Data import from a file.
- Advanced edit checks for the detection of errors and inconsistencies in the data.
- Automatic generation of “Annotated CRF” and “Blank CRF” from the eCRF design.
- Capability of making changes in the eCRF and testing them in a secure manner with no need to pause the introduction of data in the study.
- Automatic and secure randomization process integrated in the eCRF.
- Possibility for participants to fill forms digitally and the answers to be integrated in the eCRF.
- Generation of certified copies in PDF format of the participant’s data so that a copy may be stored at the end of the study.
- Possibility of introducing files in the eCRF like images, audios, videos or DICOM files.
- Automatic reports that allow tracking of the status of the study and the analysis of key indicators.
Each study will find some functionalities more appealing than others.
The capacity to accomplish a goal in less time or with less resources, is key to improving the user experience. If the user can do its job faster, its experience will be much more positive.
Efficiency in an eCRF is accomplished on many occasions with functionalities that allow the users to perform tasks in a faster way.
Another way to improve efficiency is by optimizing response times and the amount of actions the user must perform in order to perform different tasks.
The goal with such optimization is to reduce the time necessary to perform each task as much as possible, paying special attention to the most common tasks performed by the user in the eCRF.
For that reason, if the eCRF manages to reduce the time necessary to access the participant’s data and/or the access to different forms during a consultation, review or edition of the data, it will accomplish an important efficiency improvement because this task are the most performed by the users.
2º Adaptable to any study
The second feature to consider in an eCRF is its capacity to adapt to the different characteristics of any study.
Clinical studies can be very different from one another, and it is therefore very important to have an eCRF that is flexible enough to adapt to the different needs of each one of them.
Besides that, but of no less importance is the capability to adapt to different changes that may occur during the life of a study.
The percentage of studies that suffer some kind of modification once it has begun is more than 90%. For that reason, the capacity to adapt to these changes is of paramount importance.
3º Have amazing support
Last, if the selected eCRF does not offer great support the rest of the features will not matter.
Sooner or later, there will always be issues or doubts in complex environments like an eCRF, that it is essential to have great support.
When we say support we don’t mean just the solution of incidents or questions, which is also very important.
We also mean all the technical work required for the solution and prevention of problems within the eCRF. It is very important that the eCRF counts with a team capable of solving different issues in the fastest time possible and that is able to evolve as the eCRF does.
How do we accomplish this in ShareCRF
Though it is easy to explain, it is not easy to include all those features into an eCRF/EDC.
To accomplish such a high level of quality in these 3 characteristics in an eCRF/EDC, the EDC must be designed with the users in mind. Mostly this is not the case, mainly because it is harder to do so. The common option is to solve the technical problem (collect and manage data) and “force” the user to learn complicated systems.
ShareCRF has been designed thinking about providing a great user experience to all users (including eCRF designers), allowing them to adapt the eCRF to multiple circumstances via a flexible and adaptable system while keeping customer support a maximum priority.
If you want to know more about it and test it, it is easy, just request a demo.