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Does Your RBM System Support the Recently Revised Guidelines to Have a QMS in Place?

The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 addendum includes recommendations for ensuring quality management in clinical trials at the forefront. In particular, the new section 5.0 outlines recommendations for quality management, stating that "sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results" within the seven areas that are described below. Here, I also describe the key characteristics we believe, based on our experience, any RBM system should have to support these guidelines for a Quality Management System (QMS).

5.0.1 Critical Process & Data Identification

During protocol development, the sponsor should identify those processes and data that are critical to ensure human subject protection and the reliability of trial results.

Ideally, within your RBM system, you have the ability at the individual study level to identify and mark the critical data and processes that you identified during protocol development. In addition, the system should have the ability for you to associate the risk mitigation strategies identified for these data and processes. Many RBM systems have not been designed to systematically link mitigation strategies to identified critical data and processes. If you are in the process of choosing an RBM system, you may want to add this capability to your evaluation criteria list.

5.0.2 Risk Identification

The sponsor should identify risks to critical trial processes and data. Risks should be considered at both the system level (e.g., standard operating procedures, computerized systems, personnel) and clinical trial level (e.g., trial design, data collection, informed consent process).

5.0.3 Risk Evaluation

The sponsor should evaluate the identified risks against existing risk controls by considering the likelihood, impact and detectability of such risks.

For both risk identification and evaluation, a system with a built-in risk assessment and evaluation tool, such as the TransCelerate Risk Assessment and Categorization Tool (RACT) or a similar Risk Register, allows for seamless and rapid start-up of quality management. Ideally, if your company prefers the use of your own proprietary risk assessment template, you are able to upload that into your RBM/QM system and support its maintenance with minimal configuration.

5.0.4 Risk Control

The sponsor should decide which risks to reduce and/or which risks to accept.

Essentially, the full set of recommendations in this subsection outline the planning and execution of risk mitigation actions by the sponsor.

After the decisions regarding which risks require mitigation are made during the risk assessment exercise, your RBM system should allow you to fully configure risk control features that are automated and trigger alerts to the end user when risk thresholds and tolerance levels are passed. The application of machine learning to enhance identification and control of risk is the wave of the future of RBM technology and can already be found within the Bioclinica ClearSite™ product.

5.0.5 Risk Communication

The sponsor should document quality management activities and communicate those activities to stakeholders.

With role-based workflows built into your system, you can ensure timely, seamless communication with all team members and stakeholders. Furthermore, you could have a full audit trail of your decisions and related communications that can be used as evidence for the inspectors that appropriate and timely communication has occurred.

5.0.6 Risk Review

The sponsor should periodically review risk control measures to ascertain whether the implemented quality management activities remain effective and relevant, taking into account emerging knowledge and experience.

If the previous features that I described are in place, the RBM system should allow users to review and update the identified risks, Key Risk Indicators (KRIs), triggers and site scoring, among other data, to identify if the QM activities are working as intended and modify them as necessary. Having the right experience within the team aids this process, and the integration of knowledge from other systems helps the assessment remain relevant.

5.0.7 Risk Reporting

The sponsor should describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in the clinical study report.

With all QMS activities described and stored in one central location, you can have full traceability and an audit trail that ensures robust reporting of risk mitigation actions and deviations, without the need for time-consuming, manual review of the risk data and outcomes.

The revised ICH guidelines form the basis for companies to undertake clinical trials and execute them using a quality risk management approach. Having the right technology in place to support compliance with these guidelines is essential. Companies who have an existing RBM solution in place should consider performing a gap analysis to identify areas of ICH section 5 that are not being supported by the technology and determine how those gaps will be filled. For companies who are just starting their technology selection process, the suggestions above can be added to your evaluation criteria to ensure you select a technology that can act as your QMS while at the same time supporting RBM methodologies.

For more information on Bioclinica's ClearSite™ RBM technology please contact me at


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