Thousands of new drugs and medical devices are approved for market introduction each year. What many people don’t know is that they have to go through rigorous clinical trials before they are approved. Clinical trials are done to test the effects of drugs and devices.
Clinical trials must collect and record data collected from thousands of subjects. This makes the case report form (CRF) used in clinical trials an essential tool for collecting and recording data. You can check out these resources if you are 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:
- Apply basic CRF design principles
When designing a CRF or eCRF, the research design and implementation team should keep in mind generally accepted principles in clinical trials and case report design:
- The components of the clinical trial should be organized and presented in the CRF in chronological order. The sequence of component headings should be as logically consistent as possible.
- The CRF should clearly identify the location or channel of data collection and the details of the visit.
- There should be a designated area for signing. This should be done when considering the eligibility of trial participants. He should also reappear in the final part of the CRF.
- Data fields should be organized to capture data logically. The practice here is to follow the order in which the study procedures are administered during a trial session.
- Avoid putting free text input fields. These are data fields that allow the test participant to say anything. Free text reports are often unstructured and difficult to quantify.
- There should be a page header that provides clear and identifiable information such as clinical trial title, 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 test involves multiple visits.
- Ideally, you should avoid including items or questions that require calculations, calculations, or conversions.
- Limit questions and data fields to those that are relevant to the essay. Avoid duplicate questions, as this will cloud the analysis and interpretation of the data.
- Make sure your CRF’s instructions, prompts, and questions are clear and concise.
- Use a standard format to ensure consistency in your data collection and recording procedures.
- Ensure that CRF versions are controlled if you allow changes to the CRF while clinical trial research is ongoing. Enter version numbers, dates, and filenames.
- Apply standard CRF format and layout considerations
The next set of basic case report form design considerations relate to how to format and layout your CRF or eCRF. Here are some of the things to consider:
- Avoid including a “select all that apply” option among the answer choices in your CRF.
- When giving instructions and prompts, consider using bold or italics on your text.
- Pre-place decimals when asking for numbers or quantities in certain questions where you expect some of the answers to have decimals.
- Whenever you ask for something to be filled with letters or numbers, provide boxes for each character as much as possible instead of lines. This would greatly improve the accuracy of your data as it would minimize erroneous entries.
- Separate different sections or columns with section bars or thick lines.
- If you are going to request data with units of measure, indicate the required unit of measure in the response.
- Use standard formats for repetitive information such as dates. Use boxes for day, month and time.
- Put check boxes next to the answer choice instead of asking the participant or patient to circle the chosen answer.
- Make sure your instructions, prompts, and questions are clear and concise so you don’t confuse your subjects.
- Be consistent in font style, font size, and formats.
- If your CRF consists of multiple pages, use the same page numbering system throughout.
- Use portrait layout, not landscape.
The way a CRF is designed and formatted will impact data collection and recording. If a CRF is well designed, it will greatly improve the accuracy and efficiency of data collection and recording.
A well-designed CRF would also improve the accuracy of statistical analysis. Some of the format and layout considerations mentioned here are best practices to help you find a well-designed CRF.
- Basic CRF Completion Guidelines
Consider some of the basic guidelines on how to complete case report forms. The guidelines should help subjects, the trial data collection team, and the data analysis and implementation team complete 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 report completion guidelines you should consider:
- The guidelines should include instructions for CRF users to refrain from using acronyms and abbreviations.
- The CRF must be signed and stamped “completed”.
- Only authorized personnel should supervise the filling and completion of the CRF. It should be accomplished by following standard operating procedures.
- Data entry personnel should ensure that data entries are accurate.
- If the patient or participant left certain boxes unanswered, such as days in date fields, this should be filled in with ‘UK’ for ‘unknown’.
- Make sure these decimal points are in place and the correct units of measurement are used.
Case report forms play an essential role in the process of collecting and recording clinical trial data. The integrity of data collected by clinical trials is important. It ensures that drugs and medical devices sold in the market have been thoroughly tested in clinical trials and found to be safe.