An Introduction To Creating Case Report Forms (CRFs)

If you're conducting a clinical trial, you'll have to create case report forms (CRFs), which may be printed, optical, or electronic. During a clinical trial, you'll record all the information from the data acquired on each subject in each trial level on the CRF. Besides, creating a CRF will help you and your sponsors evaluate the safety and efficacy of the drugs or the intervention being developed.

While it might be overwhelming to make CRFs, you can opt for an annotated CRF, a blank form in which you can fill in details on the location, the names of the trial subjects, and the variables in the datasets. Moreover, an annotated CRF is a requirement in the submissions deliverable to the Food and Drug Administration (FDA). You must ensure that the data filled in the CRF datasheets is accurate and complete. If you're new to creating CRFs, here are a few things you should consider:

Choose A CRF Format

The first step in creating a CRF is deciding whether to use the conventional paper CRF or the electronic form. Your decision will depend on the available resources and the research size you're undertaking. For example, if the trial is small and varies in design, the traditional paper CRF might be the best option. At the same time, electronic CRF (eCRF) is suitable for large-scale trials with related designs.

Nonetheless, considering that the world is becoming a global village because of technological advancements, it'd be best to use the eCRF because of its convenience. Moreover, the electronic forms have little to no room for error in data entry, thus ascertaining accuracy. Regulatory authorities are also likely to approve eCRF submissions because they utilize electronic data capture systems which validate accuracy. The eCRF would also be practical in an organization that prefers digital documentation.

Create An Effective CRF

You must ensure that the design you're using for your CRF is effective for approval by the FDA. If you're using an annotated form for the CRF, it'd be best to check if it adheres to the conformance technical guide. A well-designed CRF should contain the following:   

• Complete, correct, and high-quality data collected throughout the trials
• Clear instructions that are interactive by using visuals, proper date formats, and decimal places for numbers
• No duplicated data
• Clear and reliable questions
• Consistent headings and subheadings to avoid confusion
• Uniform formatting is throughout the report for numbers, fonts, and sizes
• Specified units of measurement used in the CRF
• Properly structured and straightforward form
• It should be easy to input correct data to avoid ambiguity by using coded lists that limit responses and use close-ended questions
• Related questions should be categorized together

Aside from that, the collected data should be limited to what's relevant to the trial. All in all, the data must remain consistent, simple, compact, and easy to understand.

Challenges In Designing CRFs

It's common for you to encounter some challenges when designing CRF forms. Some of the challenges you might face when designing a CRF include the following:

• Ambiguity in the data provided hence being user-unfriendly
• Ensuring that the data and design are consistent
• Having irrelevant data in the forms

The good news is that each trial team member can easily address these challenges through adequate planning. It's critical that your team clearly defines the objectives of the trial before creating a design. The study's objectives will ensure consistency in the design, leaving no room for errors during data entry. Doing so is a huge advantage because the data can be used in other studies.

On the other hand, it might help to use standard CRF templates because they can help with the consistency of the design and limit irrelevant data. Gathering a lot of data might be laborious to process, and the results might be inaccurate. Moreover, collecting excessive data can result in duplication of information, making the study irrelevant.

Furthermore, you'll know whether the CRFs are user-friendly through feedback. Establishing mechanisms for user feedback that can be integrated into the CRF design is essential. The feedback can help redesign and correct the areas flagged as problematic by users.

Use CRF Completion Guidelines

Clinical trials are done in phases, and data from each level is recorded in the CRF. When finishing the CRFs, it'd be best to use completion guidelines that provide a step-by-step guide. You'll realize that CRF completion guidelines are study specific and hence have no standard templates; however, you should create them in a way that completes the CRF appropriately and with ease. While it can be confusing to make CRF completion guidelines, you can refer to the CRF completion manual on handling known and unknown data. Finally, ensure that you keep the language simple and concise.

Conclusion

CRFs play a critical role in approving a trial by regulatory bodies. When creating a CRF, you can opt for the traditional paper forms or the electronic CRF, depending on your study's scope, size, and design variables. If it's your first time creating a CRF, use a standard template to ensure accuracy and limit the data you're recording for relevance.