To ensure regulatory compliance and the quality of clinical studies, data must be recorded and stored in a regulated, uniform, and reproducible manner that allows for easy data retrieval and analysis.
Let’s say you’re the head of clinical systems at a biotech or pharma firm. In other words, you want the clinical trial to be a success at all costs. However, if your clinical study were to fail, you would want to know the reasons why as quickly as possible so that you may make adjustments to your next studies.
In order to determine what went wrong with your clinical research, you must first perform a risk evaluation on the terms that have been medically coded from the data collected throughout the trial.
Let’s take a small step back and study the function of medical coding at the very outset of data collecting in clinical trials. Life science businesses capture treatment-related adverse effects by recording medical words like “adverse events,” “medical history,” and “concomitant drugs” during clinical trials.
The FDA and other regulatory bodies require life science companies to code these phrases according to established definitions once they have been recorded.
What Do You Understand By Clinical Data Management?
Information gathered in the course of medical studies is managed through a process known as clinical data management (CDM). All data shall be checked for accuracy and completeness, as well as for conformity to company standards and government mandates.
Additionally, the CDM procedure aids in maintaining consistency among pivotal players in clinical trials:
1. Funding Organizations – pharmaceutical firms, academic institutions, and other funding and monitoring institutions.
2. CROs (control research organizations) – CROs, or control research organizations, are businesses that do research on behalf of a study’s sponsor.
3. Sites – These are the locations where information from trial participants is collected and analyzed.
CDM plays a significant role in evaluating the safety and effectiveness of pharmaceuticals, diets, medical equipment, digital therapies tools, and other sorts of treatments, diagnostics, or measures to prevent health problems. If managed correctly, it can drastically cut down on time needed to introduce a brand new medical product to the market.
● Data validation: Data anonymization, data cleansing, and data editing are all part of data validation.
● Quality checks: They are performed on clinical data to guarantee its completeness, readability, accuracy, and integrity. This includes the following steps.
● Electronic edit checks: Database designers build edit checks into eCRFs, which evaluate data entry with predefined mathematical and logical standards. This prevents improbable values from showing in the document. For instance, if the system is calibrated to Fahrenheit, a check for the body temperature field would reject any data that falls between 95 and 105.
● Source data verification (SDV): SDV is a process of validating CRF entries against original medical records and other source data. In this phase, we check that the electronic case report form (eCRF) accurately captures the participant’s characteristics.
● Data anonymization: Clinical data must be de-identified to meet HIPAA requirements before being sent to sponsors. This includes eliminating all elements of confidential health information (PHI) that can link the documentation to a particular person.
Explain The Concept Of Medical Coding In CDM
In order to produce a demographically quantifiable count of all similar terms in a given database, medical coding is the sorting of multiple similar verbatim terms using a medical (or medication-based) dictionary supplied by the user or under license by the relevant licensing bodies (MSSO, Uppsala).
In Clinical Data Management Systems (CDMS), the process of medical coding is undertaken alongside data entry, validation, processing, reconciliation, external data load, and many other clinical data management-related tasks to aid in the summarization and analysis of specific data sets.
Different medical coding dictionaries can be utilized for data processing, analysis, and reporting to ensure control and consistency. The sponsors and medical monitors will use the coded variables and phrases to examine the occurrences and medications as necessary during the trial.
Quantitative data from the coding reports are used by study statisticians and medical writing groups to populate the appropriate sections of the TLFs (Tables, Listings, and Figures) created for the study, which in turn are reflected in the Clinical Study Report (CSR) drafted for regulatory submission.
Processes must be set for managing the release of multiple versions of the same dictionary, dealing with different dictionaries or versions that have been used, and integrating data coded with different dictionaries or versions, as the managing bodies release multiple versions of medical dictionaries every year.
Medical Coding Apparatus & Techniques
When it comes to medical coding, the work is all about the software and the dictionaries. Specialist coders use this application to categorize and label the terms. Here, we’ll go through some of the key functions of the program or the generally accepted procedures that govern coding work.
Auto encoders: They are a type of software that helps translate spoken words into their dictionary equivalents. During this validation phase, the tool auto-codes any terms that are direct matches to entries in the dictionary.
Manual Coding: As part of the manual coding process, a trained medical coder looks up each phrase reported in the coding tool in a dictionary and chooses the entry that best describes its meaning. The tool’s search function and query builder should be accessible to the coding expert. Validated systems meeting regulatory criteria with audit trails should be used for the coding tool or applications. The coding reviewer utilizes the software to check the accuracy and consistency of the coded phrases in manual coding operations.
Hybrid Approaches to Coding: The most common coding setup is a hybrid technique, in which an auto-encoder is used to first automatically code the reported verbatim terms to match a term that has previously been coded (i.e., a synonym list) contained in the dictionary. The coding expert then manually encodes the remaining phrases.
Clinical Data Management Software Tools
Specialized software tools are utilized in CDM to build audit trails that allow differences to be minimized even in big and complex clinical studies. Oracle Clinical, Rave, the eClinical suite, Clintrial, and Macro are all examples of such programs. When conducting studies across several medical sites, where massive amounts of data are generated, clinical data management systems (CDMS) become increasingly important.
When it comes to major, international pharmaceutical businesses searching for tools that suit their special demands, CDMSs can be modified and even developed from scratch. Furthermore, there are free and equally effective open-source alternatives to proprietary software, such as TrailDB, open CDMS, OpenClinica, and PhOSCo.
The CDM process begins at the outset of a clinical trial, even before the study protocol is finished, to ensure the security of the collected data. The CDM group drafts a CRF and specifies its domains of data collection. The CRF defines the data to be gathered, the units of measurement to be employed, and the steps to be taken in completing the CRF (i.e., instructions for filling in data). Coded labels are used to describe the values of the variables.
The next step is to outline the trial’s critical data management (CDM) tasks in a data management plan (DMP). In order to facilitate CDM activities, databases are developed alongside compliance technologies. Before implementing the strategy with real data from a clinical study, it is tested. The next stages are to lock the database, enter the data, validate it, manage any discrepancies, assign the appropriate medical codes, and finally, to start tracking CFRs.
Medical Coding In Clinical Data Management
Medical Coding In Clinical Data Management
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