ECRF Design For Beginners: 3 Basics And Tips

Thousands of new medicines and medical devices are approved for introduction to the market each year. What many people don’t know is that they have to go through rigorous clinical trials before they’re approved. Clinical trials are done to test the effects of the medicines and devices.

Clinical trials have to gather and record data collected from thousands of subjects. This makes the case report form (CRF) used in clinical trials a critical tool for data collection and recording. You can check these resources if you’re looking for the best site for information on CRFs.

Here are some of the basic elements, principles, and considerations that CRF designers should take into account:

1. Apply Basic CRF Design Principles

In designing a CRF or eCRF, the research design and implementation team should keep in mind the generally accepted principles in clinical trials and case reporting design:

• The components of the clinical trial should be organized and presented in the CRF in a chronological order. The sequence of component headings should have a logical coherence as much as possible.
• The CRF should clearly identify the place or channel of data collection and the details of the visit.
• There should be a designated area for sign-off. This should be done when reviewing whether trial participants are eligible. It should also appear again at the last part of the CRF.
• The data fields should be organized to enter data in a logical manner. The practice here is to follow the order in which study procedures are administered in a trial session.
• Avoid putting in free-text entry fields. These are data fields which allow the trial participant to say anything. Free text reports are often unstructured and difficult to quantify.
• There should be a page header which provides clear and identifiable information such as title of clinical trial, protocol code, and subject trial number. This should appear on every page if the CRF consists of multiple pages.
• The CRF should indicate which pages were used and when, if the trial involves multiple visits.
• Ideally, you should avoid including items or questions which require some computation, calculation, or conversion.
• Confine the questions and data fields to only those which are relevant to the trial. Avoid duplicating questions because this will muddle the analysis and interpretation of data.
• Make sure that the instructions, prompts, and questions in your CRF are clear and concise.
• Use a standard format to achieve consistency in your data collection and recording procedures.
• Make sure that the CRF versions are controlled if you’re going to allow changes to the CRF while clinical trial research is going on. Put in version numbers, dates, and filenames.

2. Apply Standard Format And Lay-out CRF Considerations

The next set of basic considerations on case report form design is on how to format and lay-out your CRF of eCRF. Here are some of the things to consider:

• Avoid including a ‘select all that apply’ option among the choices of responses in your CRF.
• In giving instructions and prompts, consider using bold or italicized format on your text.
• Pre-place the decimal points when asking for numbers or quantities in some questions in which you expect some of the answers to have decimal places.
• Whenever you ask for something to be filled in with letters or numbers, provide boxes for each character as much as possible instead of lines. This would significantly improve the accuracy of your data because it will minimize erroneous entries.
• Separate different sections or columns with section bars or thick lines.
• If you’re going to ask for data with units of measurements, indicate the unit of measurement required in the response.
• Use standard formats for repetitive information such as dates. Use boxes for day, month, and time.
• Put checkboxes next to the choice of answers instead of instructing the participant or patient to encircle their chosen answer.
• Make sure that your instructions, prompts, and questions are clear and concise so as not to confuse your subjects.
• Be consistent in the font style, font size, and formats.
• If your CRF consists of several pages, use the same page numbering system throughout.
• Use portrait layout, not landscape.

The way that a CRF is designed and formatted will have an impact on data collection and recording. If a CRF is well-designed, it’ll greatly enhance the accuracy and efficiency in collecting and recording data.

A well-designed CRF would also enhance the accuracy of statistical analysis. Some of the format and lay-out considerations mentioned here are best practices to help you come up with a well-designed CRF.

3. Basic Guidelines On CRF Completion

Take into consideration some of the basic guidelines on the completion of case report forms. The guidelines should help subjects, the trial data collection team, as well as the data analysis and implementation team to fill out the forms correctly and accurately. The guidelines should also include instructions on what to do with incomplete answers, erasures and corrections, and abbreviations in the forms.

Here are some of the guidelines on report completion that you have to take into account:

• The guidelines should include instructions for CRF users to refrain from using acronyms and abbreviations.
• The CRF should be signed and stamped ‘completed’.
• Only authorized personnel should supervise the filling out and completion of the CRF. It should be accomplished following standard operating procedures.
• Data entry personnel should make sure that data entries are accurate.
• If the patient or participant left some boxes unanswered such as the days in date fields, this should be filled out with ‘UK’ for ‘unknown’.
• Make sure that those decimal points are in their proper places and that the correct units of measurement are used.

Conclusion

Case report forms play a critical role in the data collection and recording process of clinical trials.  The integrity of the data taken by clinical trials is important. It ensures that the medicines and medical devices that are sold in the market have been thoroughly tested in clinical trials and deemed safe.