Clinical Trial Manager
This application allows the users to collect the clinical data online or offline, on the same way, without learning different data capturing methods. The PDF standard gives the security and the comfortable way to capture the data.
The PDF forms shows exactly what can be seen on paper if the information is printed out, but it can give a first level error checking also, to avoid the user to create mistakes. The same application gives information to the Investigators, Nurses, Sponsors and CROs about the data.
Different user roles define if the user can only see or can modify the data. Three levels error checking assures the consistent datasets. The system installation is starting with the Protocol (creating the PDF/Paper CRF), then during the data capturing will collect all data with audit rail, and finally the clean database can be exported to statistical programs for evaluation.
The data cleaning is done by the automatic data checker and by the Query System built in the eCRF. That can be used to create a discussion for each question about the data.
At the end of the discussion the data will be checked and cleared. And the result will be the clean data.
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