Abstract: A computer system receives, before a start of a trial of a medical therapy, data that configure the computer system to detect alert conditions indicative of occurrences of failure modes identified as being potentially associated with an institutional ethics committee such as an Institutional Review Board (IRB) that reviews the trial. Respective mitigation procedures are defined for the failure modes before the start of the trial. The mitigation procedures indicate procedures to mitigate occurrences of the failure modes. Furthermore, the computer system receives IRB activity data indicative of activities performed by the IRB. The computer system detects, based on the IRB activity data that one of the alert conditions has occurred. The alert condition is indicative of an occurrence of a given one of the failure modes. In response to detecting that the alert condition has occurred, the computer system outputs an alert.

Abstract: A computer system is configured before a start of a trial of a medical therapy to detect alert conditions. The alert conditions are indicative of occurrences of failure modes identified as being potentially associated with the trial. During the trial, the computer system receives trial data. The computer system detects, based on the trial data, that one or more of the alert conditions have occurred. In response to detecting that an alert condition has occurred, the computer system outputs an alert associated with a mitigation procedure defined for the given failure mode before the start of the trial. The mitigation procedure indicates a procedure to mitigate the occurrence of the given failure mode.