With the focus and emphasis on Risk Based Monitoring, the role of the clinical research associates is changing. More than one-third of the clinical trials done today, use the elements of risk-based monitoring. Site-based monitoring had always been an essential component in clinical trials. However, with centralized monitoring being a preferred approach, there is change in the role of the clinical research associates.
With risk-based monitoring, it becomes easy to trigger pre-determined risk factors as opposed to those intervals during on-site visits. So to have a deeper sense of understanding, the research associates need to stay abreast with the developments happening during the trials and have risk analysis of the same.
The Monitor’s role in RBM is one component of an entire process of “Quality by Design” for a clinical trial. This process starts before the protocol is written and is incorporated into the protocol and a Quality Risk Management Plan. A risk-based approach to study monitoring is dynamic and more readily facilitates continual improvement in trial conduct and oversight. For example, instead of simply identifying transcription errors, the monitor and the rest of the trial conduct team now focus its time and resources to evaluate site findings in the context of a single subject, all subjects at the site, across sites in a region, or across all sites in a study. Source: appliedclinicaltrialsonline.com
CRAs are the only bridge between clinical team and on-site, so their presence in the central team meetings and decision-making process are equally relevant while risk analysis. So to support the clinical trials fully, they need to perform cross-functional management along with direct communication. Earlier it was the project coordinator taking charge of the coordination. However, the adoption of some activities by the CRA such as like escalation of risks and laying the communication plan plays a crucial role indeed, in the present day scenario.
As there is a shift in the focus of the CRAs towards risk identification, they have changed themselves into potential risk assessors. And this change in them has come mainly due to 3 important aspects namely site interaction, CRA oversight, and change in management.
With RBM having a bright future in the clinical trials, it is important for all the stakeholders including CRAs to play a better role during the clinical trials and drug development process. Moreover, it is important that the vendors and sponsors start working with the CRAs earlier during the research, to develop optimal risk-monitoring facilities. This will help to bring out the finer points that have not been focused on earlier during clinical trials.