Clinical data can be defined as any information that is related to clinical trials. It can be numeric values, figures, examination reports, medical history or medication records. Clinical data can be classified into three categories, which include source data, intermediate data, and final data. Source data refers to the data obtained from medical records, physician progress notes, surgical reports, lab reports and pathology reports. Examples of intermediate data include investigation product (IP), Informed Consent Form (ICF), and clinical intervention Case Report Form (CRF). Final data refers to the final reports produced after data has been analyzed. To ensure that high-quality data is captured effectively in clinical trials, there should be a good clinical data management (CDM) system.
These systems ensure the collection, integration and availability of sound data at the right time, right quality and the right cost. According to the National Institutes of Health (NIH), CDM systems support the conduct, analysis and management of studies across the spectrum of clinical research. The key objective of a CDM system is ensuring that data supports conclusions drawn from clinical research. Achieving this key objective helps to protect public confidence and health in marketed therapeutics.
There are many software tools available for data management in healthcare centers. In terms of functionality, all these systems have similar features, and there is no significant advantage of one over the other. Most CDM systems are expensive and require a more sophisticated information technology infrastructure to function efficiently. Some CDM systems have custom-made tools to suit the procedures and operational needs of a pharmaceutical.
Maintaining an audit trial of data management activities is an important Clinical Data Management Strategy. CDM tools help you implement an effective audit trial and allow you to manage any discrepancies properly. A good CDM system has unique tools that allow for the creation of multiple user IDs, with limited access to data entry, database designing, medical coding and quality checks. This means that each user can only access the respective functionalities allotted to them, and cannot make any other changes in the system. For responsibilities where change is allowed, the system will record the changes made, the user who made them and the time and date when the change was made.
There are many benefits you can derive by using a health data management system. To get the most out of your CDM system, you must hire the services of an established data management company. For more information about CDM tools, and how you can contact a qualified company, visit healthcatalyst.com.