The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS.
To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
Case report forms are manually filled at site and mailed to the company for which trial is being performed.
At the end of the clinical trial the data set in the CDMS is extracted and provided to statisticians for further analysis.
Most of the drug manufacturing companies are using Web-based systems for capturing, managing and reporting clinical data.
For example, RAVE can be connected to an IVRS (Interactive Voice Response System) facility to capture data through direct telephonic interviews of patients.
Besides rather expensive commercial solutions, there are more and more open source clinical data management systems [1] available on the market.
[2] CDMS implementations are required to comply with 21 CFR Part 11 federal regulations to be used for FDA registered drug trials.