Introduction 

A Risk Management Plan (RMP) is a key governance tool for the conduct of clinical trials. It provides a common risk language, an oversight of risk movement, and the ability to make informed decisions in fluid situations. In essence, it defines and explains the key components of risk in relation to clinical trial activities and provides a consistent, transparent and auditable process of risks pertinent to clinical trials. This series of articles will discuss the key elements that make up an effective RMP, with this first article delving into the reasons for, and benefits of, developing a trial specific RMP.

Overview 

At its most basic level, an RMP is a documentary model for identifying, assessing, treating, and measuring risk. It is a cyclical process whereby risks are reviewed on a regular basis and can also be employed as a first response review to avoid an adverse (undesirable) event or ‘near miss’. It is important to remember that the RMP is a ‘live’ document and is only as effective as its continual use and update; an RMP that is developed and then archived is ineffective, as only an ongoing review and update process will bring the model closer to reality.

Benefits of an RMP 

Everybody has a subjective view of risk; one person may think nothing of boarding an aircraft whilst another may be terrified of flying, and both opinions are equally valid for those individuals. An effective RMP allows the stakeholders to come to a common understanding of the varying risk levels across a broad range of categories pertaining to the trial, meaning that everyone is on the ‘same page’ in their understanding of what constitutes a high, medium or low risk in relation to undesirable events that may occur during the trial.

Of course, once decided, this is not set in stone, as the iterative review nature of the RMP allows for the understanding of risk to be recalibrated as situations change or more information becomes available.

Once drafted and consensus is reached, the RMP becomes the key tool used by all stakeholders to review and discuss risk, thereby allowing for targeted discussions using a common vocabulary. One of the most effective uses of an RMP is as a quick review tool at operational meetings. It is important to list on the agenda, as it will allow stakeholders (both internal and external) to raise any issues or concerns in the language of the RMP, making their input more pertinent to the identified trial risks, and allowing the RMP itself to be easily fine-tuned to accommodate their concerns.

In addition to being a regulatory requirement under ICH Guideline for Good Clinical Practice (GCP), an RMP facilitates an effective audit trail for decisions made about risk throughout the trial. It can be used to establish the logic and assumptions underlying risk decisions. Furthermore, actions and improvements implemented in response to emerging risks, changes in circumstance, and adverse events should be documented.

Given its iterative nature, an effective RMP has a built-in continuous improvement cycle. However, the outputs of the RMP can also be incorporated into an organisation’s quality management infrastructure, providing a multiplier effect to their QA maturity, and feeding back into all aspects of GCP.

Conclusion

An effective RMP is more than just nice to have, it is a regulatory requirement which drives constant improvement in the approach to risk, resulting in a better outcome for sponsors, sites, CROs, and participants. Let us help you develop an effective, ongoing risk management plan for your clinical trials - get in touch today.

Upcoming articles in this series will conduct a deep dive on the individual elements of a RMP, discuss effective stakeholder engagement, review regulatory and audit requirements, and suggest continually improvement strategies.