Picture courtesy: eclinicalsol.com
Clinical research and clinical data management (CDM) go hand-in-hand. Clinical trials which are a part of the clinical research aim at investigating a research query with thoroughly standardized procedures. This primarily requires collecting large amounts of data and analyzing it to prove or disprove a hypothesis which is the main idea of the research. Thus, data plays a critical role in the whole procedure of research and clinical trials and here comes the significance of clinical data management in the clinical trial procedures.
With proper clinical data management training, students get to understand that CDM is crucial for every clinical research task as it facilitates generation of high-quality and reliable data that conforms to the statistical procedures. Students who are trained from the best clinical data management training institutes learn the best practices of collecting, integrating and making the collected data available to the stakeholders within the cost constraints of the clinical research organizations. As discussed already, CDM involves management of large chunks of data which cannot be managed manually and for this purpose; CDM managers use certain tools that make the work easier and manageable for them.
Clinical data management training helps students understand the various software tools that facilitate handling huge data. A clinical data management system (CDMS) is a tool used by clinical data managers to manage data of clinical trials and this can be categorized into two systems: paper-based and electronic data capturing systems.
Paper-based systems: In this format of the system, the case report forms are manually filled and then this data is transferred to a CDMS tool by doing data entry work. This data in CDMS is validated for which data clarification is sought in paper form again.
Electronic data capturing systems: In this format of the system, the clinical trial data is directly uploaded on the CDMS and this data can be viewed by the validation staff.
There are different CDMS tools used by pharmaceutical companies and clinical research organizations that are either commercial or open source tools. Some of the most popular CDMS tools are eClinical Suite, Oracle Clinical, Macro, RAVE, and clinitrial. These tools are commercial tools and used by big companies as they are expensive. To use these tools, the companies even require investing in IT infrastructure. Apart from the commercial software, there are some open source tools that are helpful for students undergoing clinical data management training.
The CDMS tools play a critical role in the audit trails of clinical trials and research which are very important from the point of government rules and regulations. People who are involved in clinical trials are given unique user IDs that give them access to limited functionalities depending on their job profile. This kind of restriction to various functions also helps in tracking the changes made by various people at various levels that facilitate avoiding and identifying any discrepancies.
Clinical data management training institutes like Ikya Global help the students understand the regulations, guidelines and the best practices that are required to be adhered to in this profession.
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