UNIFARM performs monitoring activity with monitors compliant with the requirements of the DM dated March 31, 2008.
In particular the Monitor is responsible for:
-verifying that the clinical studies are performed, recorded and reported according to Good Clinical Practice (GCP) and other applicable laws;
-performing a pre-trial monitoring visit to document that the site is suitable for the trial;
-performing a trial initiation monitoring visit to document that the trial procedures were reviewed with the investigator and trial staff;
-checking the accuracy and completeness of the documents in order to ensure the targets are reached throughout the study
-performing monitoring visits during the study according to the monitoring plan and applicable SOP;
-discussing problems with the medical staff and promptly send out monitoring reports
-performing close-out monitoring visit to document that all activities required for the close-out have been completed.