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January 27, 2023
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3 Ways To Ease The Process Of Creating CRF Annotations

One of the most important documents in clinical research is a case report form (CRF). Essentially, this document is critical in data collection, organizing data in a format that simplifies and facilitates data analysis.

And in the clinical research industry, the Clinical Data Interchange Standards Consortium (CDISC) sets the appropriate guidelines or standards when dealing with medical research data, including CRFs and their annotations. 

What Are Annotated CRFs?

An annotated CRF refers to a blank case report form with annotations or markings, coordinating data points in the CRF with their corresponding dataset names. Annotated CRFs communicate where the data gathered for each clinical research query is stored in the secure database. 

In this article, you’ll learn how to ease the process of creating CRF annotations to help you make your process more seamless and attain your clinical research objectives and goals faster. 

  • Embrace Automated CRF Annotations 

Manual creation of annotations for every single case report form is often time-consuming. Make CRF SDTM annotations a lot easier by switching to automated CRF annotations.  

Automating CRF annotations allows using metadata to create the annotations, and with just one press of a button, the CRF design is viewable in PDF format. Also, making changes becomes less monotonous and hassle-free with automated CRF annotations with an instant preview upon completion. 

Save time reusing annotations from one clinical research study to another and across multiple Electronic Data Captures (EDCs) without re-typing everything. Just imagine how much time and effort you’ll save by automating annotations.  

Adding several annotations on the CRF or question is also possible with automation. It’s also possible to have links between datasets and links, notes for reviewers, and annotations for various teams. Customizing the format, font, and font color are also possible.  

In addition, choosing an automated CRF annotation platform built on CDISC-compliant templates automatically makes them compliant with the latest regulatory standards, like the Food and Drug Administration (FDA). 

  • Know The Requirements 

Knowing the requirements of creating CRF annotations can help ease its process. As mentioned, CDISC developed data standards and guidelines that pharmaceutical industries must comply with when conducting clinical research on various medical innovations and healthcare investments.  

For example, CRFs must map each item that corresponds to the dataset variables without leaving anything behind. You should also present and annotate all the items and pages by describing the variable names as available in the tabulation datasets, including items not submitted in datasets. And in terms of file format and naming, annotated CRFs must be in a PDF file with the name “blankcrf.pdf.” 

Following these specifications promotes the success of clinical research submissions to the FDA and other regulatory bodies. CRF management generally involves dealing with hundreds of pages with an enormous number of items on each page. Because this task can be demanding, automating CRF annotations is highly recommended to achieve efficiency without compromising standards and quality. 

  • Follow The Right Steps For The Manual Method 

While convenient, clinical research teams may still face tech crises from time to time. So, using the manual method is still far from getting obsolete. Although manual consolidation involves hands-on work, both programmatic and manual methods are efficient in creating annotated CRFs. 

For the manual method of annotating CRFs, the creation of several copies of CRF books is necessary. There must be a group that splits the CRF copies and assign the task to various individuals to annotate the chosen CRFs.  After which, each individual exports the created CRF annotations as PDF files or text files describing the annotations. These files provide relevant details about the locations, content, page number, and other characteristics of the annotations. The PDF file copies are manually imported to the corresponding case report forms on the master CRF book. 

With manual CRF annotations, the original version matches exactly with the annotations from the copies. The original version’s annotations can reflect the updated version if there are changes or updates. This is possible by inserting new pages in the annotated copy and following the same steps in importing the annotations from the original version to the updated one. 

If you prefer the programmatical method of annotating CRFs, you’ll need individual CRFs. The program has a library of keywords and value pairs (dictionary of objects), wherein the user manually fills in a dictionary object to search for a keyword. But creating PDF files and filling in the dictionary of objects is only one time. Once these elements are set, everything is automated.  

 

Conclusion 

Creating CRF annotations can be made easy by applying the tips above. You can automate CRF annotations to save time and effort, allowing clinical reviewers and staff to focus more on data analysis, reporting, and decision-making. It’s also crucial to follow the specifications when creating CRF annotations right from the start for compliance purposes and avoid wasting time correcting errors. 

 

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