Clinical Data management Systems and its Types in Clinical Research

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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.

Steps of Clinical Data

Clinical data collection is very challenging and innovative task in clinical research. The clinical data generates at various stages and its maintenance is becoming a crucial task for Clinical data management professional’s clinical data is generated at various stages from its designing to presentation.

The clinical data is generated at following stages

• Data Design

• Data collection

• Data Entry

• data Validation

• Data Cleanup

• Data Analysis

• Data Reporting

• Data Presentation.

Importance of clinical data

As clinical research has lot many stages involved before manufacturing of the drug to its delivery to the end user; there is huge data generated at each stage. The maintenance of this huge data become necessary to keep track of each and every activity conducted at each stage.

This data gives us the information about that particular drug that will be helpful for the researchers as well as to produce its Biosimilar.

It will also help to analyze the patient’s response for chemically similar drugs response on the drugs.

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 trials 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

CMD is not an easy task it requires professionals at various stages and it requires very sharp and workaholic candidates to maintain record of overall activity. The members involved in clinical data management system are

• Project Manager /Data Manager

• Database Administrator

• Database Programmer / Developer

• Clinical Data Associate