Risk management consists of a number of processes or activities that are undertaken throughout the lifecycle of a clinical trial for identifying, evaluating, monitoring, controlling, preventing, mitigating, communicating, and reviewing any process (or factor) that threatens the trial’s quality. Here, we discuss how to manage risk in clinical trial development.
Risk in Clinical Trial Development – Assessment
In this step, potential hazards or harms are identified that may compromise the reliability of the trial’s results or might pose a threat to the participants’ wellbeing and safety. Thus, it requires a comprehensive review of the aspects crucial for ensuring a trial’s quality and to identify the risks to these factors systematically.
In this step, you decide whether to accept or reduce the risks. The main aim of this step is to mitigate risk to an acceptable level. In this step, a risk control plan must be created and implemented. When risks have a low (or limited) impact on the reliability and integrity of data, and the safety and rights of the trial participants, they’re deemed acceptable. However, if a risk isn’t acceptable, an appropriate risk mitigation tool or strategy must be used to reduce risk.
Risk communication refers to the sharing of information between a trial’s stakeholders, about the risks as well as their management. Therefore, a risk communication plan must be in place, which should highlight what has to be communicated, when, and with whom.
Ideally, this plan must be developed as part of the risk management process and constantly reviewed through the course of the trial.
Risk in Clinical Trial Development – Review Process
This step is the process where tools and strategies that have been implemented as part of risk management are monitored and evaluated. This constant review of the process is suggested to ensure identification and management of new risks, and risk management tools employed are effective.
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