Clinical data management (CDM) is the process of collecting and managing research data in accordance with regulatory standards to obtain quality information that is complete and error-free. CDM is essential for examining the security and efficiency of medical treatments, tools, digital therapeutics, etc. If dealt with correctly, CDM can drastically lower the amount of time needed to launch a new medical product.
The goal is to gather as much of such data for analysis as possible that adheres to federal, state, and local regulations.
Stages in Clinical data management:
Clinical data management goes through eight stages in order to achieve this goal:
Set up
The first stage is to set up the overall plan, database, and forms that will be used in the study. This includes preparing for data collection and ensuring that all necessary tools are in place.
Collect
Data is then collected over the course of the study. This may include collecting patient information, clinical trial data, and other types of data.
Assure
The third stage is to confirm that the plan, tools, and data meet the requirements, including data quality. This helps to ensure that collected data is accurate and error-free.
Identify
The fourth stage is to monitor for issues or risks. This includes identifying potential problems with the data or with the study itself.
Preserve
The fifth stage is to protect the integrity of collected data. This includes storing data in a secure location and ensuring that it is backed up.
Integrate
The sixth stage is to map different datasets and information together in a cohesive, consistent format. This helps to ensure that all data is compatible and can be easily analyzed.
Analyze
The seventh stage is to analyze the data. This may include using statistical methods to understand the data, looking for trends, or testing hypotheses.
Report
The final stage is to report the findings of the study. This may include writing a paper, presenting at a conference, or publishing the results. It is an important process that helps to ensure that quality information is collected and managed effectively.
By following these eight steps, researchers can obtain accurate and reliable data that can be used to improve patient care.
How Does Clinical Data Management (CDM) Work in Practice?
Even before the study protocol is complete, the CDM procedure begins at the start of a clinical trial. The CDM team develops a case report form (CRF) and defines the data fields to be used. CRFs describe the type of information to be recorded, as well as how to fill out the forms. Coded terms are used for variables. The CDM team also develops a data dictionary, which is a list of all the variables and their definitions.
When the clinical trials in Europe start, patient data is collected and entered into the EDC system. The data is then checked for accuracy and completeness. Data that is missing or does not meet quality standards are corrected or flagged for further review. Once the data is cleaned, it is ready for analysis.
Benefits of Clinical Data Management (CDM)
There are many benefits of clinical data management, including:
– improved data quality;
– reduced costs;
– increased efficiency; and
– improved compliance with regulatory requirements. Clinical data management is essential for obtaining accurate and reliable data. Clinical research may also require medical writing for various stages of the process, from drafting the protocol to publishing study results. Clinical research associates (CRAs) may also be involved in data management.
Challenges of Clinical Data Management system
There are a few challenges associated with it , such as:
– maintaining data quality;
– ensuring compliance with regulations; and
– managing large amounts of data. It is a complex process that requires careful planning and execution. However, by understanding the steps involved, researchers can ensure that their data is of the highest quality.
Сlinical data management software
To manage clinical data effectively, you need software that is capable of handling large amounts of documents and is customized for medical studies — clinical data management system (CDMS), also called electronic data capture (EDC) system. Clinical data management software helps you automate and streamline the data collection process, making it more efficient and accurate.
Some of the features of clinical data management software include:
– Data entry forms that are customizable for different studies
– Ability to track changes to data over time
– Audit trails to track who made what changes when
– Electronic signatures to ensure data integrity
– Version control to track different versions of data
– Data export features for easy analysis
By using such software, you can improve the efficiency and accuracy of your data collection process, making it easier to obtain quality information that is complete and error-free. Clinical data management software is essential for examining the security and efficiency of medical treatments, tools, digital therapeutics, etc. It helps you automate and streamline the data collection process, making it more efficient and accurate.
