We strongly encourage the IRB to review the plan. Each IC should have a system for appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data. IC oversight of the monitoring activities is distinct from the monitoring itself. Oversight of monitoring must be done to ensure that monitoring plans are in place for all phase I or II trials and that the IC is informed of recommendations and any necessary actions that emanate from the monitoring activities. Investigators must ensure that the NIH is informed of actions, if any, taken by the IRB as a result of its continuing review.
ICs have the flexibility to determine the reporting requirements of adverse events.
The reporting requirement to the NIH may range from individual adverse event reports to summary reports from the monitoring group. Occasionally, there are phase I or II trials that have established safety monitoring committees. The overall elements of the monitoring plan may vary depending on the potential risks, complexity, and nature of the trial. In phase I and II trials, a number of factors influence risk. A phase I trial of a new drug or agent may involve increasing risk, to a small number of participants, as the drug is escalated in dosage.