Annotated CRF SDTM – If you’ve ever involved yourself in any clinical research process, you’d know that annotated case report form (CRM) is an essential document used for data collection and processing. More so, it’s a mandatory deliverable for Food and Drug Administration (FDA) submissions. It helps in the management of data, which can then produce reports. And as such, annotated CRM can aid in tracing variables as the FDA reviews the submitted datasets.
And while it has shown excellent benefits to the research process, it can be more significant when merged with the study data tabulation model (SDTM). Essentially, SDTM refers to the system used to standardize the organization and formatting of data. This, in return, can help streamline the data collection, management, and analysis process.
Indeed, annotated CRFs are no longer a stranger to clinicians. In fact, today, thanks to modern technology, automating annotated CRF can now be possible. With this, it can help eliminate tedious and time-consuming manual work. You can check out Formedix to learn more.
With that in mind, this article details the many ways annotated CRF SDTM can help streamline clinical research processes.
Ensures Data Accuracy And Consistency
Annotated CRF combined with SDTM can help streamline clinical research processes and make the lives of clinicians, researchers, and pharmaceutical professionals easier.
With annotations, you’d get to highlight critical terms or items in the form by utilizing comments and notes. This can provide clinicians with more comprehensible information, making them understand the dataset provided better and easier.
More so, since datasets are more likely to be handled by various parties, having annotations can ensure data consistency and accuracy throughout the research process, regardless of who’s viewing the material.
Offers Better Clinical Data Management
Annotated CRF SDTM can be used as a standalone system or integrated into other methods to increase efficiency in clinical data management and other areas. For instance, during the research process, you and your team are more likely to encounter and work with volumes of data. It can be overwhelming and tedious sorting it all out, and that’s where annotated CRF combined with SDTM can be beneficial.
You can add notes and comments on the form to consolidate all of the data you have. And when data has been collected and well-curated, it becomes easy to manage. Through clinical forms and by following the tabulation model, clinicians get to enjoy improved data visualization, labeling, and categorization, leading to improved data management and enhanced data quality.
Helps In Clinical Trial Recruitment Management
Clinical trials are an essential part of the clinical research process. Clinicians use them to test new drugs, treatments, and other therapies. However, the clinical trial also involves recruitment management. This refers to finding people willing to participate in the trial.
The annotated CRF combined with SDTM can help in the recruitment and retention processes in clinical trials. Clinicians use this for any clinical trial, regardless of the phase. With this in place, it can provide clinicians an easy way to get all the information needed for recruitment purposes, like contact information and eligibility criteria. It also streamlines retention processes by making it easier for investigators to track who has dropped out of their study and why to improve the research process.
Aids In Clinical Trial Patient Identification And Tracking
Annotated CRF SDTM can also help streamline the clinical trial and track the clinical research process. Through this, researchers can create a database with all the required information about the patients participating in the clinical trials.
That way, they can identify and track patients at reduced time and effort amid the pandemic and Omicron uncertainty. This reduction can help foster the efficiency of the overall process.
How Annotated CRF SDTM Improves Clinical Research Outcomes
Annotated CRF combined with SDTM can be beneficial to clinical research outcomes. Clinicians use it primarily for two purposes: data collection and data entry.
Its first use is to collect information about the patient’s medical history. The second use is for data entry, which includes entering the patient’s vital signs, physical exam findings, and other information from the clinical encounter.
With annotated CRF, it can provide clinicians an effective way of mapping each item to its correlating variable within the dataset. This can then grant them more time to focus on their research. In other words, it can be time-saving and cost-effective.
Final Words
Annotated CRF plus SDTM is considered a massive breakthrough in clinical research. Until recently, it was nearly impossible to track and manipulate clinical records efficiently. But now, clinicians can do a lot with data and enjoy several benefits. These merits are often resulting from streamlining clinical research processes.
