Clinical Data Management System, its Benefits &Types of clinical Data

Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry.

Clinical Data Management (CDM) System

Clinical Data Management is a system or a tool that includes overall data generated in clinical trials of particular medicine. CDM is collection, integration, validation of clinical trial data. In clinical trial investigators collect data on patient’s response to particular drug for a defined period. This data is then forwarded to the sponsor to analyze it using statistical analysis.

Clinical data has to go through following steps:

Data Design, Data collection, Data Entry, data Validation, Data Cleanup, Data Analysis, Data Reporting, Data Presentation.

Steps Followed in the process of clinical data management

The process of CDM are described below

• Source information is created. Basic cases of source information are clinical site restorative records, research center outcomes, and patient journals.

• If paper Case Report Forms (CRFs) is being utilized, the clinical site records are interpreted onto the CRFs.

• Data from the CRFs, and also other source information, are gone into the clinical preliminary database. Electronic CRFs (eCRFs) enable information to be entered specifically into the database from source reports. Information from paper CRFs are regularly entered twice and accommodated keeping in mind the end goal to diminish the mistake rate.

• The information is checked for exactness, quality, and culmination, and issues are settled. This frequently includes questions to the clinical site. See more about information approval.

• The database is bolted when the information are viewed as last.

• The information is reformatted for detailing and investigation. Tables, postings, and figures are created.

• The information is investigated, and the examination results are accounted for. At the point when noteworthy outcomes are discovered, this progression may result in the age of extra tables, postings, or figures.

• The results are coordinated into abnormal state documentation, for example, Investigator's Brochures (IBs) and Clinical Study Reports (CSRs).

• The database and other examination information are chronicled.

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.

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

• It improves overall production rate of the system.

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 Management

The members involved in clinical data management system are

• Project Manager /Data Manager

• Database Administrator

• Database Programmer / Developer

• Clinical Data Associate