Adverse events can occur unexpectedly requiring investigators to rapidly respond and make treatment decisions using study-defined guidelines that are buried within an extensive protocol document. ClinOne programs the dose modifications and adverse events of special interest guidelines from the protocol and places them in a simple, searchable format for investigators and study personnel.
The research teams identify the adverse event, look up grade of adverse event, then the system provides the specific instructions from the protocol and IB to handle each event. The technology also links to the contact information to the medical monitor and AE submission portal (if applicable).
