Solutions Clinical Data Management System
A clinical data management system or CDMS is used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors because of human entry, the systems employ different means to verify the entry. The more popular method being double data entry.
At one time the data has been screened for typographical errors, the data can be validated to check for logical errors. A good example is a check of the subject's age to ensure that they are inside the inclusion criteria for the study. These errors are raised for review to determine if there is an error in the data or clarification from the investigator is required.
Another function that the CDMS can perform is the coding of data. Currently, the coding is commonly centered around two areas; adverse event terms and medication names. With the variance on the number of references that can be made for adverse event Terms or medication names, standard dictionaries of these terms can be loaded into the CDMS. The data stuff containing the adverse event terms or medication names can be linked to one of these dictionaries. The system can check the data in the CDMS and compare it to the dictionaries. Items that do not match can be flagged for further checking. Some systems allow for the storage of synonyms to enable the system to match usual abbreviations and map them to the correct term. As an example, ASA could be mapped to Aspirin, a usual notation. Popular adverse event dictionaries are MedDRA and WHOART and popular Medication dictionaries are COSTART and WHO Drug Dictionary.
At the end of the clinical trial the dataset in the CDMS is analyzed and sent to the regulatory authorities for approval.
The Department of Veterans Affairs (VA) Decentralized Hospital Computer Program (DHCP) contains data modules culled from separate ancillary services (for example, Lab, Pharmacy and Radiology). It is now difficult to integrate information between the modules. A prototype is in development aimed at integrating ancillary data by storing clinical data oriented to the patient so that there is easy interaction of data from many services. A set of program utilities provides for user-defined functions of decision support, queries, and reports. Information can be used to monitor quality of care by giving feedback in the form of reports, and reminders. Initial testing has indicated the prototype's design and implementation are feasible (in terms of space requirements, speed, and ease of use) in outpatient and inpatient settings. The design, development, and clinical use of this prototype are described.
Implementing a clinical data management system (CDMS) involves a of choices at all levels. Data managers face the intimidating task of getting consensus around quite literally thousands of issues. Data standards should be created, a thesaurus put in place, input screens developed - and all the parts need to work together. It's a mountain of detail, and with each step upward the clock is ticking.
Clinical directors and vice presidents face an equally mountainous task: they need to ensure that everything possible is done to maximize benefits from the new CDMS. Decisions abound, how will the CDMS relate to legacy systems? How will redundant data in several systems be reconciled? What about concurrent or future initiatives such as an Electronic Data Capture (EDC) system? And above all, how does this system get deployed on time, and on budget?
With CDMS, you can energize your clinical data management procedure. The CDMS is at the heart of your clinical research machine, the engine that drives projects to the earliest possible data lock.