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FUNCTIONS > AE
MANAGEMENT
 This is the central module that allows for the complete management of the information gathered.
The section for entering the events (Editing/Browsing) is made up of various areas of input:
_ General Data,
_ Patient Data,
_ Primary Source,
_ Drugs,
_ Reactions,
_ Relevant Tests,
_ Summary,
_ Medical History,
_ Past Drug History
The functions of "Electronic Submission" of the events are prearranged for input into the EUDRA DB DataBase with the respective attributes defined by the
international standard
E2BM.
Notification of the Follow Up regarding various cases previously entered is enabled by an instrument made for that purpose.
The Research module in the events database provides an advanced filter based on the most common parameters distinguishing the events, even
chronologically.
Safety.DB includes also an instrument for the Automatic Generation of the standard forms available (CIOMS Forms, Ministerial Forms and others...) in draft and official versions (for sending to companies and regulatory authorities).
The structure of the documents generated corresponds with the ICHICSR DTD 2.1 specifications and the general rules defined by the EMEA.
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e-crf
