Friday, July 24, 2009

Clinical data management system

Clinical data management system

This is what I understood what clinical data management system is in the simplest way....

Data is collected during clinical trials. These data are entered into the computer for checking errors based on existing knowledge on the topic. The computer cross checks for errors and points out errors. If there are errors, then it is sent back for correction and the whole process is done again.

Here goes my weird example.... clinical data says the person is taking pregnancy pill ..... computer does a verification to check if the patient is female... and finds that the entry shows the person is male...... it is a logical error.... it means someone has goofed up somewhere during dataentry or some stage.

If you want a bit more booky answer try this one....

A clinical data management system is used to manage the data for clinical research. The data gathered in case report form are stored in the CDMS. Once the data has been screened, the data can be validated to check for errors.

An example is a check of the subject's age to ensure that they are within the inclusion criteria for the study. These errors are raised for review to determine if there is an error in the data or clarification from the investigator is required.

The CDMS can also be used in coding of data. Currently, the coding is generally centered around two areas; adverse event terms and medication names. The system can check the data in the CDMS and items that do not match can be flagged for further checking. Some systems allow for the storage of synonyms.

At the end of the clinical trial the dataset in the CDMS is analyzed and sent to the regulatory authorities for approval.


It seems companies like Accenture are doing this........ Want to try out the new career path......?


Disclaimer: The above info is layman's idea (mine!) of what the topic is.... for exact thing refer some real dictionary or an encyclopedia !