The first version of MCC RA&MMT was released in 2016 – prior to the release of ICH E6 (R2), MCC conducted a review of the tool to ensure that it supported the risk-based approach to quality management outlined in ICH E6 (R2) section 5.0. The review found that RA&MMT 1.0 did not fully support the process described in 5.0.1 “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”. MCC’s Study Quality Trailblazer Work Group decided to modify RA&MMT 1.0 so it supported the process described in section 5.0.1. Additionally, the work group conducted a survey of those who had used the tool to determine if other updates were needed to improve the user experience.
|RACT 2.0||RA&MMT 1.0||RA&MMT 2.0|
|70+ potential risks||✔||✔||✔|
|Risk score by combining Likelihood, Impact, Detection||✔||✔||✔|
|Suggested mitigations for potential risks||✔||✔||✔|
|Prioritization by individual risk rather than risk category||✔||✔|
|Use of a risk statement to assist with scoring||✔||✔|
|Clear definitions of Likelihood, Impact, Detection||✔||✔|
|List of potential MCC metrics to use for Detection||✔||✔|
|Collection of risk reduction actions||✔||✔|
|Encourage critical thinking by avoiding checklist approach||✔|
|Aligns with ICH E6 (R2) – Critical data/processes followed by risks||✔|
|Enhanced definitions of Detection||✔|
|Aligns with ICH E6 (R2) – Quality Tolerance Limits||✔|
|Allows rescoring of risk based on risk reduction actions||✔|
|List of possible MCC KRIs to use for Detection||✔|
MCC RA&MMT 2.0 fully aligns with ICH E6 (R2) section 5.0. It has also been enhanced to encourage critical thinking. Rather than users having to score every one of the potential risks, the starting point is establishing critical data, processes and the risks related to those. The list of potential risks has become a library rather than a list requiring scoring of every item. The tabs have been reorganized to show clearly which are for data entry and use and which are for reference. The definition of detection is clearer in the new version to take account of the time component – that a good detection provides a signal in time to take action to impact the outcome. The ability to re-score the risks after considering risk reduction actions on the high priority ones has been added. Actions should reduce the risk score but this re-scoring helps to determine whether the risk score is reduced enough or whether additional actions are required. The list of MCC metrics has been updated and includes the MCC Key Risk Indicators.
At-A-Glance — Document providing an overview of the MCC RA&MMT Toolkit 2.0
Recorded Webinar and Slides — Introduction and background to the MCC RA&MMT 2.0
MCC RA&MMT 2.0 — The tool ready for use
MCC RA&MMT 2.0 Instructions — Detailed instructions on how to use the tool – including screenshots
Recorded Webinar Demo — Demonstration of the use of the tool
MCC RA&MMT 2.0 with Sample Data — The tool with sample data as an example
The MCC Risk Assessment & Mitigation Management Toolkit is available to all MCC member organizations. MCC representatives are invited to log in to the MCC Member Portal to download the toolkit. Contact MCC Customer Service if you need assistance.
RA&MMT v2.0 toolkit includes the MS excel-based tool and implementation support tools. An introductory webinar provides information about the tool and detailed instructions provide you step-by-step instructions on how to use the tool.
The excel tool contains three tabs designed to be completed by the study team.
- Meeting Participants – to record those participating in the meetings developing and reviewing the RA&MMT v2.0 for a particular study/portfolio
- Critical Data and Risks – to record the critical data, processes & associated risks
- Risk ID Eval & Control – to list the identified risks, evaluate those risks and develop controls for the significant risks
The remaining tabs are to be used by the study team as reference tools.
- Risk and Control Library – A listing of potential risks along with suggested measurements, risk controls and issue mitigation. This could be expanded by your organization in the light of experience.
- Risk Evaluation Guidance – Guidance on how to evaluate risks from the perspective of likelihood, impact and detection
- MCC Metrics & KRIs – A list of current MCC metrics and KRIs that may be useful in evaluating and/or controlling risks.