Clinical data management (CDM) is a critical process within the realm of clinical research and trial. CDM can be defined as the process of collecting, cleansing, and managing data throughout a clinical trial, producing accurate, reliable data which can be used for the safe development of drugs and treatments. Not only does a sound CDM process reduce the amount of time it takes for a drug to become marketable, but it also ensures that pharmaceutical companies are compliant with regulatory requirements, enhancing safety around consumption.
If you’re pursuing a career in clinical research, your knowledge of the CDM process will improve your ability to obtain and deliver quality data, avoiding unnecessary errors while creating a more efficient trial. Below, discover more about clinical data management, how it has evolved, the tools used in the process, and more.
The Evolution of CDM for Those in Clinical Research Training
Clinical Data Management (CDM) first came about as a result of necessity, with both regulatory bodies and other stakeholders in the pharmaceutical industry looking for a way to safely develop pharmaceutical products while bringing them to the market as quickly as possible. With CDM, data can be quickly and accurately analyzed, expediting the drug evaluation process.
Today, the CDM process relies on the use of specific software and tools, requiring an extensive Information Technology network. These tools enable professionals with clinical research training to handle a large amount of data, especially when trials are multicentric, or taking place in many different areas. This software may include:
- Oracle Clinical
- eClinical Suite
While the CDM used to rely on the use of paper to store laboratory data, the use of these technologically-advanced tools enables regulatory bodies to conduct more efficient data audits, avoiding discrepancies or falsities.
The Clinical Data Management Process
The CDM process involves several steps, designed to deliver a clean and accurate database to regulatory bodies at the end of a clinical trial. Below is a preview of the steps making up a typical CDM process:
- Study documents completed: At this stage, the trial protocol is reviewed and a Case Report Form is designed to define data fields and items, accounting for the frequency of data collection. Once the form is completed, a Data Management Plan (DMP) is created, outlining the CDM activities which will be performed in the trial. A Data Validation Plan (DVP) is also created in order to ensure the proper cleaning of the data.
- Database design: Clinical software applications are optimized for data entry, with different study details defined and CRF layouts created.
- Collecting of data: Data from the clinical trial is collected, using the CRF to collect responses.
- CRF tracking: Clinical research professionals will analyze data entries in CRF to ensure accuracy and completeness, checking for illegible or incomplete data.
- Data validation: The validity of data is tested according to protocol, determining discrepancies and conducting quality control measures.
- Query resolution: Discrepancies are checked, investigated and fixed in order to clean the data.
- Medical coding: The medical terminologies used in the clinical trial are categorized and identified, helping to keep the data consistent.
- Database locking: A final data validation check is run, after which the database is locked and the data is extracted and archived.
After earning your clinical research diploma, you’ll become familiar with these steps as you work to ensure that data from clinical trials is accurately and efficiently obtained and organized.
The Composition of CDM Teams
On any CDM team, there are various roles and responsibilities carved out for each member. With a strong understanding of their areas of purview, teams can come together to ensure an effective CDM process.
The CDM team members include:
- Data Manager: Responsible for overseeing the entire process
- Database Programmer: Creates the database, conducts data validation, and more
- Medical Coder: Codes for medical history, adverse conditions, and more
- Clinical Data Coordinator: Creates CRF, DVP and discrepancy management system, and prepares all guideline documents
- Quality Control Associate: Verifies documentation and performs data audits
- Data Entry Associate: Performs data entry
As you train for a career in clinical research, your knowledge of CDM will help you to optimize the clinical trials and research you perform in order to improve data collection, contributing to a faster process.
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