A Case Study in Adopting Trancelerate’s Risk Assessment and Categorization Tool

By now, there is strong consensus that Risk Based Monitoring (RBM) is an essential practice in clinical research. There are ample resources and supporting data on the benefits of a Risk-Based approach to monitoring, and we will not add to the chorus of voices promoting its adoption.

Rather, let’s describe the challenges HighPoint has encountered in adopting and developing practices related to RBM. The first is working with remote monitoring practices and online analytics 15 years ago as a matter of necessity to support large, late phase observational trials. In this series, we will look at three challenges that teams face in the order that a research team may encounter them.

Risk-Based Monitoring

The first challenge is the formal risk assessment, the foundation of a risk-based approach to clinical monitoring. In this case study, we’ll review the summary of two pilots of Trancelerate’s Risk Assessment and Categorization Tool (RACT), and lessons learned from that effort.

Next, we’ll explore the unique challenges that analysts face in central monitoring, and offer several alternatives to allow busy statistical analysts to join the RBM team.

Finally, we’ll take a clear-eyed look at the challenges of RBM adoption from an organizational perspective, and how these challenges may be addressed through judicious organizational change management.

Trancelerate, the non-profit industry group dedicated to improving clinical research, provides guidance for planning a project that follows a risk-based approach. The RACT provides teams a clear first step. The RACT is a thorough document, but its scope and size were difficult for the team to absorb. An Excel spreadsheet of nine tabs, nearly 90 questions, covering the gamut of clinical trial risks is intimidating at first glance. With a few precious exceptions, the research team thought that the RACT was an added burden — work that would delay efforts to enroll the first patient, with little, if any, tangible benefit. It was clear that we would need to eat this elephant one bite at a time. 

To start, we revisited our RBM training, and customized the training to the specific project and project team. During the training, we showed a couple of high-level slides on the project, and the rest addressed the specific concerns of the team, protocol, and research sponsor. This reduced the team’s trepidation, but they remained concerned about the additional, up-front effort involved in completing the RACT.

There was no way to reduce the effort, as the team needed to be engaged and committed to successfully complete the first RACT.  We needed to treat the first RACT as a pilot, to ensure that the lessons learned were shared with the organization and were used to enhance the RBM training program. Treating it as a pilot encouraged the team and the wider organization to support the effort.  We decided to conduct two pilots with two separate teams simultaneously.  


We aggregated the team’s feedback, and incorporated it into the training and customized a company version of the RACT.  We ranked the feedback from these observations:

  • A dedicated, experienced facilitator is clearly needed. Even though the expectation was for a project manager to lead, in one case it was the medical monitor who led the process. The facilitator could pre-populate the RACT for questions that are not applicable, and ensure that all stakeholders are engaged.
  • Identifying the variables adds time to the process and should be handled in a subsequent meeting.
  • RACT completion should start as soon as possible once the protocol is available. It’s also preferable to have a clinical project kick-off meeting.
  • The RACT aids the project manager (particularly for novice project managers) to prepare for the kick-off meeting and facilitate discussions with the client.
  • The teams had to be reminded to consider BOTH probability (the chance that an event will occur) AND impact (what would be the event in case the risk occurred) separately – the tendency is to choose one level of risk and apply it to both criteria

The pilot teams evolved from resisting the RACT to promoting its use for all new trials. 

The value of RACT

The RACT represents a valuable tool for the study team and project managers. They made the following recommendations and observations:

  • evaluate potential risks on a study,
  • document potential risks in a consistent manner,
  • identify critical variables for monitoring,
  • facilitate discussion with the client,
  • and to set a foundation for the monitoring plan.

At HighPoint we offer Risk Assessment administration to research teams for both sponsors and Contract Research Organizations who are seeking to augment their experience and expertise in RBM.

In our next blog post, we’ll illustrate the analysts’ perspective on the challenges of RBM and we’ll finish this series with a discussion of the Meeting the Organizational Challenges of RBM.

See HighPoint’s Successful Adoption of a Risk Based Approach to Clinical Monitoring for information on assessing specific and systematic risks, investigating and navigating them in a focused and targeted manner. RBM may result in fewer site visits over the life of a clinical trial, and more site visits and investigative focus in areas and sites that need it most.