The Medical Monitor should be a person not involved in the study so that they can render an independent, non-biased decision regarding protocol changes, evaluation of adverse events, and enrollment of subjects not meeting protocol requirements. Also, they must not have a conflict of interest. The Medical Monitor should be a licensed MD/DO, but not necessarily one involved in the specific disease state being treated under the protocol for which they are the Medical Monitor.
Duties include:
• Ongoing monitoring and evaluation of reports of SAEs related to the study submitted by the study site in real time to ensure good clinical practice and to identify safety concerns quickly.
• Suggest protocol modifications to prevent the occurrence of particular AEs, e.g., modifying the protocol to require frequent measurement of laboratory values predictive of the event or to improve expeditious identification of SAEs.
• May serve as a resource to the clinical investigators and the Sponsor for advice about management of SAEs, but may not be involved in other aspects of the trial.
• Evaluation of all SAEs from each site active under the protocol for which they are the Medical Monitor.
• Evaluating whether the potential deviation from granting an inclusion/exclusion waiver would be justifiable by determining if the deviation would be considered ‘safe’ for the subject [ONLY when permitted by protocol].