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Clinical Data management and its Types in Clinical Research

What is clinical data management System (CDMS)?

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.

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 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- 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.

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.

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.

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