Requirements and considerations when developing eCRF pages

What is an eCRF?

eCRF’s are basically the data entry forms which make up the study in the Electronic Data Capture (EDC) system. They are the electronic version of a paper questionnaire in a study.

During the course of an eCRF study build, consideration has to be given to the end user experience. There is a need for investment in time and resources to ensure that the eCRF pages are suitable for the study. If companies do not make this investment there is a risk that changes, or additions, will be required later, which will be costly, require time and could have broader implications on operations. Users need (and want) to be able to enter their data as quickly and as easily as possible.

Considerations for creating eCRF’s using nowEDC

To ensure the end user experience is successful there are two main considerations:

1. Can the data be entered as easily as possible?

2. Can the data entry be streamlined to what is actually required for entry?

nowEDC eCRF page designs are based on these two simple ideas. The first of which can be best demonstrated by the use of “value lists”. These are simply pre-set lists of values that the user can select in response to a question, instead of having to type the answer, which can be both laborious and prone to typographical errors.

It would be quite odd if a user had to type the answer to a Yes/No question in instead of simply clicking on the response, so for these types of questions, we rely on a simple button list

Although other options are available, such as dropdown lists and radio buttons (shown below)

It makes more sense both visually and from a data entry perspective to use buttons, in this case.

For longer lists of values, it makes more sense to use a dropdown list

than radio buttons, or buttons

These simple design choices can help ensure that users always enter the correct response in the most user-friendly way possible.

What is an Indicator?

So, what about those eCRF pages with many interlinked questions?

Datatrial’s Study Build Team use a piece of nowEDC functionality we call “Indicators” to add/remove questions from the page based on the answers provided to other questions.

Here is an example…

If “Was this assessment performed?” is answered as “No”, then no further data entry is necessary, so the page is simply submitted as is, with no further data entry required.

If the answer is “Yes”, then the rest of the questions are presented, as required

This principle can also extend to other questions in the page, such as the “Ongoing?” question.

When “Ongoing?” is answered as “No”, the “End Date” question is displayed

In this way, we can enhance the user experience, so that data entrants can enter their data quickly and efficiently.

Ultimately, the requirements and considerations when developing eCRF pages is the way the eCRF is built affects the user experience. Datatrial’s Study Build team can advise the best approach to enhance user experience but ultimately the final say is that of the sponsor. Taking into account the considerations above can provide seamless and easy data entry, saving time to get on with other things.