Most medicines and medical devices have to go through a clinical trial before being introduced and sold to the market. These trials are generally done to test the therapeutic claims of such products by using case reporting forms (CRF) as the primary data gathering tool.
If you’re looking to know more about CRFs, you’ve come to the right place. And although printed CRFs are commonly used in the industry, recently, there’s a rise in the use of electronic case form (eCRF) due to its convenience and accuracy.
That said, this post outlines some of the things that every first-timer should know about eCRF design. This includes the basic principles, format considerations, and completion guidelines.
- Follow Basic eCRF Design Principles
eCRF has basic design principles that the research and design team should follow. This will help ensure consistency in your recording procedures. It will also help maintain consistency in collecting data.
To start, here are some of the generally accepted principles of electronic case reporting design for clinical trials:
- The clinical trial’s various components should be placed in the eCRF in an organized manner. Ideally, they should follow a chronological order according to how the clinical trial is going to be implemented. And as far as practicable, the component headings of the eCRF should follow a sequence and have a logical and rational coherence.
- The eCRF should clearly state where the eCRF will be filled out. It should also elaborate on the details of the visit for the data collection.
- There should be a specific portion where the trial participants can affix their signatures. This should happen at least twice. First, they should be asked to sign off when participants are being verified about who is eligible. Then they should also be asked to sign off again at the end portion of the eCRF.
- Avoid creating entry fields where participants would be free to fill out the fields with any text or character. This means avoiding providing data fields that allow the participants to write just anything they want unless the research needs elaboration from the participant. The reason behind this is that the results may become unstructured and may be difficult to quantify.
- The eCRF should have a page header. It should be able to provide clear information on the protocol code, title of the clinical trial subject, and the trial number of the subject. This should appear on each page of the eCRF if it has more than one page.
- Refrain from including questions or items that would require the trial participants to do conversion, calculation, or computation. Evaluate the prompts, questions, and instructions; make sure they’re clear and concise. In addition, avoid including duplicate questions, as this can muddle the interpretation and data analysis. And more so, the eCRF design should be limited to data fields and questions which have relevance to the clinical trial.
- If you’re going to allow changes to the eCRF before the data collection is completed, make sure that you have control over all the eCRF versions whenever there are changes made. Save filenames, dates, and version numbers.
- Considerations On Format And Layout
Aside from the basic design and methodology principles, the eCRF design team should also try to come up with a standard format.
Here are some of the format and layout considerations that they should take into account:
- The design team should consider writing instructions and prompts with a mix of italics or boldface text formats. Read them aloud several times to test if they’re clear and concise. In addition, the use of standard font style and font size throughout the eCRF is also ideal. This is to make sure the participants won’t be confused.
- Use portrait layout. Don’t use landscape orientation.
- Use a standard format for dates and other repetitive information. Allocate a separate box for each digit of the day, month, and time.
- Avoid asking participants to fill in blank lines with their answers. This can help minimize errors in entries and enhance the accuracy of your trial results.
- Signal to the participant the division of one section or column from another by placing thick dividing lines or section bars.
- Refrain from giving trial participants an option to ‘select all that apply.’ As much as possible, don’t include this among the multiple choices in any question.
- Ask participants to check the boxes next to their answers rather than drawing circles on their chosen responses.
- If you’re going to ask questions answerable by quantities or numbers, pre-place the decimal points in the eCRF. And on the other hand, if you’re going to ask for quantities or numbers that have a unit of measurement, pre-place the unit of measurement next to the data field.
- Use a uniform page numbering system for all the pages of your eCRF for the entire duration of the clinical trial.
- Basic Completion Guidelines
The design team should also come up with basic guidelines on how the eCRF would be filled out and completed. Here are some basic guidelines which they can use:
- Participants should refrain from using abbreviations and acronyms.
- Only trained and authorized personnel should oversee participants when filling out and completing eCRF.
- They should come up with parameters on what to do should there be erasures, corrections, and incomplete responses.
- Once done, the eCRF should be stamped as ‘completed.’
Conclusion
Case report forms (CRFs) play a crucial role in collecting and recording data for clinical trials. And with that in mind, a well-designed eCRF can significantly help improve the data collection and recording process. Even first-timers should know and familiarize themselves with the basic design principles, format considerations, and guidelines for completing eCRFs.
