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Clinical trials to test medications and other treatments generate a lot of data that must be managed and checked for accuracy. A clinical data management system is a tool experimenters use to keep track of all of this data. These systems can be paper based or electronic, and are sometimes managed by an outside company. Clinical data management systems typically include a way to keep track of all the subjects in a clinical trial, a way to report adverse events, a calendar, and a way to view the results of laboratory tests.
Clinical trials are controlled experiments to test the effectiveness of a treatment for a disease. A clinical trial usually works by having two groups — one group that takes the treatment and one group that does not. The data from these two groups is compared to see if the group that took the treatment improved more than the control group. In order to find results, all of the data from both groups must be carefully recorded and checked for errors. The clinical data management system takes care of this task.
Researchers in a clinical trial fill out case reports, documents that record the information from each subject in the trial. These case reports are sent electronically or on paper to a data manager, who enters them in the system. Often, two separate people will enter the same set of data, and the system will compare the two entries. This helps reduce errors in entering the data. The recorded data is then checked for logical errors; for example, if someone’s age is recorded as 240 years, it is probably a mistake.
One very important function of clinical trials is to test for adverse reactions to the experimental treatment. A clinical data management system usually has a module built in for adverse event reporting. This helps the researchers keep track of how often subjects in the trial experience a particular side effect.
A clinical data management system also keeps track of all the subjects in the clinical trial. Some electronic programs even let the subjects enter their own information. These systems are also useful in keeping information confidential.
Another useful feature that many clinical data management systems have is a calendar that keeps track of the experimental schedule. For example, a subject may need to take a certain medication every other day, and see a researcher once a week to be evaluated. The clinical data management system helps subjects and researchers stick with the schedule.
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