7 Best Practices For Annotated CRFs

Annotated case report forms (CRFs) help streamline your clinical trial and medical research data. Annotating a CRF makes it a powerful tool you can use for developing metadata. It documents the location of the data and corresponds them with datasets, including the names of the variables within them.acc

To develop a well-structured annotated CRF, the following are some tips you should follow:

1. Switch To Automated CRF Annotations

There’s a huge amount of data to handle in a clinical trial. While doing this manually is common, you can settle for automated CRF annotations, eliminating the monotony and huge time requirements.

The following are the benefits of using automated annotated CRFs.

• Bookmarks are done automatically, and there’s no need to do this repeatedly.
• It’s easier and quicker compared to the manual process.
• It’s less tiresome, and boredom is alleviated.
• You can easily edit the annotations and forms.
• You can use standardized annotations on different studies.
• You can achieve consistency using the same text, color, and position.
• Your documents will be of high quality.

With automation of clinical trials, you’ll have a more productive and efficient annotation process.

Annotation serves as a translation between two documents at different abstraction levels; hence, it’s better to annotate your study data tabulation model (SDTM) and CRF together. This means the annotated CRF SDTM bridges the data collection and management that may be misinterpreted or cause confusion.

2. Formatting Recommendations

The following are the best practices you should follow while formatting your annotated CRF:

• File name: The annotated CRF should be a PDF document with the file name ‘acrf.pdf.’
• Page numbering: Your page numbering should be done on the final annotated CRF.

When referencing a CRF page number, use the numbering defined on the PDF document and not the original one on the CRF page.

• Instruction boxes or comments: You should include additional comments on instruction boxes in your CRF during the study to help in explaining SDTM mapping. Make sure to remove them when making the final copy.

With this formatting; your document will be adhering to the instructions given by the FDA’s Study Data Technical Conformance Guide.

3. Use Cross References Where Needed

Cross references are a great way to maintain consistency among your CRF data files. They’re a viable method to track an individual in your clinical study using pointers. With this, you can easily and effectively keep tabs on various fields you consider important to your study, so you can use them for reporting. These cross references are how companies streamline their drug development process, and you may want to implement the same.

4. Content Recommendations

The following are some content recommendations when working on an annotated CRF:

• It should be complete and inclusive of the final unique modules and pages, with no blanks.
• It should include additional collection documents that weren’t transcribed into the CRF, such as patient diaries.
• It shouldn’t have database annotations on it.
• Instead of submitting additional documents as part of SDRG, you should append them on the annotated CRF.

The content recommendations above will help you develop a complete clinical trial CRF.

5. Logical Grouping Of Information

Necessary information should be logically grouped to avoid separating them. Depending on how you’re sectioning your annotated CRF, ensure it follows a given logic. For example, if you’re grouping the information by topic, have subtopics to explain the groups. If you’re sectioning using paragraphs, have a header and a detailed explanation of what’s in the paragraph.

Logically grouping your data improves their usability, and readers can easily find data portions relevant to them without reading every word in the text, looking for a specific point. 

6. Bookmarks

Your annotated CRF should contain bookmarks. Based on the guide, the bookmarks should be created in two ways:

• Alphabetical: Bookmarks in a topic should be ordered based on the study event schedule.
• Chronological: The topics are ordered by time, based on the study schedule.

Your bookmarks should have as many forms as possible to show how data were collected.

7. Include The Coding Specifications

There are various SDTM variables you’ll collect for your study. These will help you easily and consistently collect and store data from the study participants during the survey. These coded values will represent how you want to record data on your research and improve your analysis. Having the coding specifications for the SDTM variables you’re collecting in the study will speed up the process.

Conclusion

Annotated CRFs should be user-friendly and readable. A well-designed CRF gives you a clear visualization of what your study group will have to complete using dropdowns and checkboxes. With the few best practices listed above, you should be able to develop a detailed CRF.

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