Clinical
Data Management is the process of handling a data that is acquired from the
clinical trial. Clinical Data management
has the aim to protect the data and maintain quality data. The data collected during a
clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision
making on product development in the pharmaceutical industry.
Clinical Data Management is a very important tool for managing the medical data. This process is important because imaging a hospital with a lot of patients and medical records, but unable to manage them properly. These were the traditional way to have records on paper. But with the clinical data management methods, clinical trials are easier and can be done over the internet also. Paperless internet trials can be the future of Clinical Data Management. The advantages are that it keeps the paper behind and eliminates paper in trials, even in the doctor’s office. Also the savings from the Clinical Data Management are more than the use of paper.
Today, even the IT industry is also entering the clinical trials market. The importance of Clinical Data Management is that you get fast data, correct data and electronic trials save paper. The best example of Clinical Data Management is Oracle’s Oracle Clinical. This application is used to set up and manage Clinical Data Management projects. There are many software tools that are capable of data management and they are called Clinical Data Management System. The common ones are Oracle, Macro, Rav, eClinical Suite and Clinical trial.
There is a data flow, which has to be
followed during the process. Once subject
enrolment begins, the clinical data manager ensures that data is collected,
validated, complete and consistent.
Standard Operating Procedures (SOPs) describe the process to be followed in conducting data management activities and support the obligation to follow applicable laws and guidelines (e.g. ICH GCP and 21CFR Part 11) in the conduct of data management activities.
At the completion of the clinical trial, the clinical data management ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the clinical data management transfers data for statistical analysis.
Standard Operating Procedures (SOPs) describe the process to be followed in conducting data management activities and support the obligation to follow applicable laws and guidelines (e.g. ICH GCP and 21CFR Part 11) in the conduct of data management activities.
At the completion of the clinical trial, the clinical data management ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the clinical data management transfers data for statistical analysis.
Clinical Data Management is a very important tool for managing the medical data. This process is important because imaging a hospital with a lot of patients and medical records, but unable to manage them properly. These were the traditional way to have records on paper. But with the clinical data management methods, clinical trials are easier and can be done over the internet also. Paperless internet trials can be the future of Clinical Data Management. The advantages are that it keeps the paper behind and eliminates paper in trials, even in the doctor’s office. Also the savings from the Clinical Data Management are more than the use of paper.
Today, even the IT industry is also entering the clinical trials market. The importance of Clinical Data Management is that you get fast data, correct data and electronic trials save paper. The best example of Clinical Data Management is Oracle’s Oracle Clinical. This application is used to set up and manage Clinical Data Management projects. There are many software tools that are capable of data management and they are called Clinical Data Management System. The common ones are Oracle, Macro, Rav, eClinical Suite and Clinical trial.
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