What is clinical data management System (CDMS)?
Clinical data management is the system or a tool of managing & storing high quality data generated in clinical trial. Clinical Data Management saves the time of maintaining the data from development to marketing hence it is a very important part of clinical trial. This data maintained in CDMS is very important to keep record of patient’s registries.
The members from clinical Data management are actively participated in clinical research activities from beginning to end and they are having sufficient knowledge of the system that will help them to maintain the overall quality standards of CDMS. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. CDM professionals should meet the relevant expectation and set standards according to the change in technology for the best quality data.
Elements of Data Quality
The FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations defines the fundamental elements of data quality for both paper and electronic records by “ALCOA”:
Attributable: The source of the data is known.
Legible: The data are readable and comprehensible to humans.
Contemporaneous: The data are recorded when they are generated.
Original: The data are the first recording from the primary source.
Accurate: The data are correct.
Practically, quality data also requires at least three other aspects:
Data are readily available, transmissible, and storable.
Data are complete and unbiased.
Data are in a format that is internally consistent and compliant with or readily transformable to accepted standards.

Types of Clinical Data
Clinical data is a staple resource for most health and medical research. Clinical data is either collected during the course of ongoing patient care or as part of a formal clinical trial program. Clinical data management system falls into following types
· Electronic health records
· Administrative data
· Claims data
· Patient /Disease registries
· Health surveys
· Clinical data Trial
Let us discuss them one by one
Electronic health records
It is type of clinical data obtained at hospitals, health care centers, or in clinics. The data can be prescription of drugs, laboratory tests, psychological monitoring data, diagnosis, treatment and patients insurance. It is also referred as the electronic medical record-EMR of clinical data management system; it is not available for outside researchers.
Administrative Data
Administrative data is often with electronic health record, and these are non-clinical research data focused on record-keeping surrounding a service, such as hospital discharge information.
Claims Data
As the name resembles it includes data regarding insurance claim. It includes billable interactions between the patients and insurance company. This data is again subdivided into four general categories as inpatient, outpatient, pharmacy and enrollment.
Patient /Disease registries
Patient registries are systems used to keep record of key data for certain chronic conditions such as Alzheimer, diabetes, cancer, heart diseases, bronchitis etc. These systems help to track the clinical data of the patient populations; it also provides critical information for managing patient conditions.
Health surveys
In order to provide an accurate evaluation of the population health, national surveys of the most common chronic conditions are generally conducted to provide prevalence estimates. National surveys are one of the few types of data collected specifically for research purposes, thus making it more widely accessible.
Clinical Data Trials
Clinical data trial includes all the data obtained during clinical research trials of the medicine or a drug.
Key Members Clinical Data Managemen

The members involved in clinical data management system are

• Project Manager /Data Manager
• Database Administrator
• Database Programmer / Developer
• Clinical Data Associate

Benefits of Clinical Data Management
Following are the benefits of Clinical Data Management
· Well structured database and well organized information
· Experienced clinical data managers provide the data with very less error rate.
· Better traceability of data and potentially faster approval
· Fastest time to time market and commercialization cab obtained because of CDM
· CDM is a trusted partner of life science organization