An electronic case report form (eCRF) is a digital or electronic questionnaire used for collecting data research and studying participants. The creation of an eCRF aims to improve the manual process of gathering and entering data, one piece at a time, by the clinical researcher or participants themselves.
Biostatisticians, clinical researchers, and other healthcare workers performing clinical studies and trials are generally reliant on the data presented by these forms. The contents themselves are considered valuable information, of which preciseness and accuracy are required. And the reason why a whole system of safety features, requirements, and controls is needed is to ensure that all of the forms are reliable and credible enough to be used.
Keep reading below for the must-know basics of professional eCRF design using formats like ODM and CDASH that clinical researchers can use to their advantage.
- Apply The eCRF Design Principles
The requirements of every eCRF would generally differ depending on the type of research or study the eCRF is to be used for. Notwithstanding this fact, however, there are general design principles that every eCRF should meet for it to be considered effective and well-made.
Let’s jump right into what those basic eCRF design principles are, all of which can be applied to any electronic platform – not just medical eCRFs, for that matter. Some of these include:
- The data fields should be well-organized, such that data can be entered in a logical manner. Typically, the arrangement would be to start by following the order in which the study procedures are administered in every trial season.
- The components in every case report form should be presented in chronological order. This means that whatever subject headings your form has, it has as much logical coherence as possible.
- The data fields shouldn’t allow free text. This means that trial participants shouldn’t be able to type anything at random, of course, unless they’re asked to describe or state experiences and conditions in their own words. Otherwise, having a lot of space for free text can make your eCRF more unstructured and less quantifiable.
- Remove Any Uncertainty
Surely, you’ve all been there when answering forms. And perhaps, there’s that question that’s as confusing to comprehend as the answers are. Then, you’ve grumbled to yourself why the makers of that questionnaire didn’t just simplify the questions and answers.
Now that you’re the ones designing the case report forms, aim to remove any uncertainty. This means staying as clear and direct as possible. Yes and no questions are generally favored, so have those whenever possible. You can make the choices direct, too. A simple ‘Yes’ or ‘No’ will suffice, over unnecessary phrases like ‘Yes, that’s true’ or ‘No, that doesn’t apply.’
- Only Ask For Applicable And Necessary Data
Don’t ask for any more information than what you need. It can be a waste of space and time and may also be completely unnecessary. Moreover, this could only complicate the results of your clinical study when you have a lot of data to sort through and deal with. For that reason, design your form in such a way that any non-relevant questions or those that don’t contribute anything to your clinical case study can be omitted.
In addition, study and contemplate what kind of information you need. That way, you can design your line of questions to generate the information you need. Consider also the patients answering your forms based on their respective clinical situations. It’s rarely the case that two patients have the same specific data points which need to be collected.
- Apply The Standard Format Expected With eCRF
Layout and apply all expected standard formats with eCRF. Those are generally the bare minimum requirements needed to be applied when drafting an eCRF.
As your guide, here’s a list of what that standard format usually entails.
- Adjust the text such that form instructions and prompts are either in bold or italics.
- Use standard formats for any repetitive information on your eCRF, such as the dates. To make your form even more specific and accurate, have a separate box for the month, day, and year.
- Pre-place decimal points in the questions where you expect the patient or clinical researcher to use the form to put a decimal point.
- Enable ticks or check boxes to the choice of answers instead of encircling multiple-choice questions, as is done with physical and non-digital case report forms.
- Be consistent with your choice of font size and style, to avoid any unnecessary confusion.
Clinical researchers should have a unified aim to design better and more professional eCRF designs. The purpose of those forms isn’t just to come up with more accurate clinical research and study but also to save time and resources.
When eCRF designs are well-thought-of and well-made, the chances of errors can be reduced. With that in mind, don’t rush the process of designing your eCRF. Take it as something that should be done precisely and thoroughly to avoid the mishaps of wrong and inaccurate clinical studies.