Clinical data management systems are used to manage and verify data from clinical trials. They track subjects, report adverse events, and view lab test results. These systems help reduce data entry errors and keep information confidential. They also include a calendar to track the trial schedule.
Clinical trials to test drugs and other treatments generate a lot of data that needs to be managed and verified for accuracy. A clinical data management system is a tool that investigators use to keep track of all of this data. These systems can be paper or electronic and are sometimes managed by an outside company. Clinical data management systems typically include a way to track all subjects in a clinical trial, a way to report adverse events, a calendar, and a way to view lab test results.
Clinical trials are controlled experiments to test the effectiveness of a treatment for a disease. A clinical trial usually works with two groups: a group that accepts the treatment and a group that doesn’t. The data from these two groups are compared to see if the group that took the treatment improved more than the control group. To find results, all data from both groups must be accurately recorded and checked for errors. The clinical data management system takes care of this task.
Researchers in a clinical trial compile case reports, documents that record information about each trial subject. These case reports are submitted electronically or in hard copy to a data manager, who enters them into the system. Often two separate people enter the same set of data and the system will compare the two entries. This helps reduce data entry errors. The logged data is then checked for logical errors; for example, if someone’s age is recorded as 240, that’s probably a mistake.
A very important function of clinical trials is to test for adverse reactions to experimental treatment. A clinical data management system usually has an integrated form for reporting adverse events. This helps researchers track how often study subjects experience a particular side effect.
A clinical data management system also keeps track of all clinical trial subjects. Some electronic programs even allow subjects to enter their own information. These systems are also useful for keeping information confidential.
Another useful feature of many clinical data management systems is a calendar that tracks the trial schedule. For example, a subject may need to take a certain drug every other day and see a researcher once a week to be evaluated. The clinical data management system helps subjects and investigators stay on schedule.
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