An electronic case report form (eCRF) is a web-based and digital questionnaire used to collect patient information. Healthcare workers enter essential information into the forms by doing it manually piece by piece, uploading in bulk, or using an external data source, such as an imaging database. Whichever way information is input into the form, the most important criterion to meet is accuracy—the digital case report form must be prepared well.
Those who have been performing clinical research and investigations know that eCRFs are important in drawing conclusions. Data included in the forms are analyzed by researchers and biostatisticians to reach a conclusion.
eCRFs also allow you to share data with stakeholders, make collecting accurate observations and findings easier, regulate data storage for clinical care and research, and offer real-time access to data. Hence, there should be no room for error, even at the starting point of drafting the CRFs.
Here are some tips for creating an effective digital case report form.
1. Know The Characteristics Of A Well-Designed eCRF
To begin with, you need to ask yourself this question as part of the clinical team: What are the characteristics of a well-designed eCRF? Knowledge of what a well-designed eCRF is will help guide you and your team members through the design process.
The following is a list of some of the most important characteristics of a functional eCRF. Keep them in mind, so you can come up with good lab reports and other medical documents:
- It should be consistent, user-friendly, uncluttered, and simple.
- It should be able to gather data that are high-quality, complete, and accurate.
- It shouldn’t gather any more data than is needed.
- It should avoid duplication.
- It should be well-structured.
2. Complete The Key Components Of An eCRF
Now that you know what makes a good eCRF, you need to have a checklist of the key components of the form. These key components include:
- Data validation: It’s the message that pops up when certain values or letters entered into the form aren’t acceptable.
- Form label: It refers to that descriptive title describing the kinds of questions asked.
- Choice labels: They’re a must-have as an option guide when answering multiple-choice questions.
- Group label: Also called the sub-title, it’s used in every section of the form to describe the questions.
- Value: It refers to the data entered into the field, usually in the form of a drop-down menu with different choices.
- Item label: It’s a directive meant to instruct what information should be entered into a specific field.
- Field: It’s a blank section or area where information should be entered.
- Item description: It’s the note that gives specific information about the item to be entered (e.g., whether it should be in pounds or kilograms).
3. Eliminate Any Uncertainty
Draft your ECRF in such a way that the individual filling it out or completing it won’t have any uncertainties as to what information to include. To do this, ask questions that are explicit.
For example, there’s no need to say, ‘If yes, check this box,’ when you can merely have a direct ‘Yes’ or ‘No’ category. This makes your form a lot easier for anyone to understand.
4. Never Skip The Instructions When Needed
Don’t assume that the individual reading or filling out the eCRF possesses the medical knowledge you have. So, to be safe, avoid skipping any necessary instructions, particularly for those sections that may have highly technical terms.
5. Make Data Fields Mandatory
If there are data fields that are mandatory because they affect the form’s accuracy, make them clear in your forms. These mandatory data fields should be completed to finish the form.
You can include selections for opting out of certain questions in case the user will feel the need to do so. For example, provide options, such as ‘not applicable or ‘I don’t know.’
6. Obtain Quantifiable Data
Quantifiable data refers to anything expressed as a number or any number that can be measured. It’s needed to gain favorable results of an analysis in order for the clinical study to be complete. Some examples of quantifiable data to use are those that refer to the weight of the subject, scores on achievement tests taken, and even the number of hours spent on the study.
There are ways to successfully obtain quantifiable data, which usually depend on what’s needed by the clinical study. Note, however, that the method of collecting quantitative data may impact your patient’s or subject’s responses. For instance, adding multiple-choice questions with expected answers as choices or possibilities is one way. If these choices or possibilities aren’t applicable, you can provide a text field to get the applicable answer or a possibility that includes ‘other.’
7. Set Rules For Numeric Inputs
Setting rules for numeric inputs is necessary to develop a sense of uniformity in your eCRF. This way, you’ll avoid receiving wrong data that are caused by misunderstanding what each numeric input means.
For example, you intend to use kilograms as the weight measurement in all your forms. Make it clear that weight-related questions should be answered in kilograms.
Conclusion
An eCRF affects communication, compliance rates, and data quality. Without an accurate eCRF, your clinical research won’t be successful. Therefore, it’s important to understand the characteristics and components of the form, as well as the principles behind its design.
Author’s Bio: Sally Durham is a medical researcher and guest contributor on health and wellness websites. When she’s not busy working at the clinic or the lab, you can find her at the local pet shelter as a volunteer.
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