Standardization and the Importance of Medical Coding Dictionaries in Clinical Trials
The data gathered in a clinical trial is often collected by many different people, including investigators and coordinators, and interpreted by data managers and regulatory authorities. When the success of your research depends on controlling and understanding data collected during the trial, it is important to ensure every role who interacts with the data is reporting and interpreting the results in a consistent manner.
Why Use Medical Coding Dictionaries?
To conduct clinical trials, many sites and organizations rely on an electronic data capture (EDC) system to help them collect and store their data during a trial. During the trial timeline, these data are analyzed, and the results need to be shared with regulatory authorities. For example, the FDA requires detailed reporting for adverse events (AEs), which often require summarization by system organ class or body system. So how do you ensure that each role across a multi-site or global trial records information like AEs in a standardized way? To solve this problem, researchers use medical coding dictionaries, to standardize the language they use to report adverse events, medications and more.
Commonly Used Medical Dictionaries and Best Practices
Common medical dictionaries used in clinical research include MedDRA , used to classify adverse events, CTCAE, an NIH developed coding dictionary for coding and grading adverse events in Oncology, and WHODrug, used for coding concomitant medications. To maximize the benefits of coding dictionaries, it’s best practice to incorporate them into study start up and initial data collection so you can spend less time reviewing your data. Some EDC systems support this by allowing coding dictionaries to be imported into the system, so standard terms will auto populate into selections you can make.
Medical coding prevents common problems such as spelling errors, incorrect abbreviations, or non-standardized terms. Medical coding prevents common problems such as spelling errors, incorrect abbreviations, or non-standardized terms. For example, say a handful of participants mention they are feeling a potential side effect from the trial therapy. One participant may report suffering from head discomforts, while another reports experiencing dizziness. Standard coding dictionaries will help organize those otherwise scattered terms into a standard parent category, which can help identify important trends within the trial.
Not only does this form of standardization protect your clinical trial from misinterpretation of trial-related terms, it also increases the efficiency of the trial itself. When less revisions are necessary, less time is spent reviewing the trial data, and the study can come to conclusions faster so the next plan of action can be taken.
Implementing standard medical coding dictionaries into your trial workflows minimizes incorrect interpretations and can expedite your trial timeline. To learn more about incorporating efficient workflows into your research operations, sign up for a personal EDC demo.