Regularly Monitor Study Risks using an Optimized KRI Dashboard

The KRI Starter Kit allows users to select a number of critical operational measures and assess them for risk across sites and countries on a regular basis. Using CluePoints’ comprehensive range of statistical algorithms, study teams are able to surface potential risks by using an independent and objective approach to testing clinical and operational data. Our team of RBM experts will work with your team to identify the most effective KRIs for your studies and configure them within the CluePoints KRI Dashboard.  The integrated Signals and Issues Tracking Management System will capture all potential risks and pass these to the right stakeholders for resolution.

ICH E6 (R2) and RBM Consultation

The RBM Starter Pack includes consultation that covers the following topics:

  • ICH E6 (R2) overview and an introduction to RBM methodology
  • Overview of the pre-study risk assessment & mitigation planning process, the TransCelerate RACT template, and a client-specific refinement of questions using the CluePoints RACT solution. Training will also be delivered on the CluePoints RACT tool, including a group exercise to conduct a risk assessment for a target study.
  • Key Risk Indicators (KRIs) – A review of their purpose, key considerations for optimal effectiveness, and a review of the standard KRIs proposed by CluePoints as part of the KRI Starter Kit.
  • Data Quality Assessment (DQA) Overview – Introduction to comprehensive statistical data monitoring as a next step in risk detection – what it comprises and its critical importance in surfacing operational risks that may not have been anticipated via pre-study risk planning.

Key Risk Indicator (KRI) Starter Kit

The KRI Starter Kit includes a KRI Dashboard that is configured with:

  • 8 CluePoints standard (“optimized”) KRIs
  • 2 Additional study-specific KRIs as discussed and agreed in initial consultation
  • Access to the CluePoints Signals and Actions Tracking Management System
  • Up to 20 users

CluePoints Central Monitoring Platform Training

The RBM Starter Pack includes training on Central Monitoring Platform (CMP):

  • Introduction to the CluePoints platform, SMART engine methodology and how clients are using the solution
  • Demo of CluePoints including RACT, KRI dashboard, Signals & Action Tracking Management System, Patient Profiles, and overview of set-up process (for potential full solution use in future).
  • Access to the CluePoints eLearning Platform
  • Up to 20 users

ICH E6 (R2) and RBM Consultation

The RBM Starter Pack includes consultation that covers the following topics:

  • ICH E6 (R2) overview and an introduction to RBM methodology
  • Overview of the pre-study risk assessment & mitigation planning process, the TransCelerate RACT template, and a client-specific refinement of questions using the CluePoints RACT solution. Training will also be delivered on the CluePoints RACT tool, including a group exercise to conduct a risk assessment for a target study.
  • Key Risk Indicators (KRIs) – A review of their purpose, key considerations for optimal effectiveness, and a review of the standard KRIs proposed by CluePoints as part of the KRI Starter Kit.
  • Data Quality Assessment (DQA) Overview – Introduction to comprehensive statistical data monitoring as a next step in risk detection – what it comprises and its critical importance in surfacing operational risks that may not have been anticipated via pre-study risk planning.

Key Risk Indicator (KRI) Starter Kit

The KRI Starter Kit includes a KRI Dashboard that is configured with:

  • 8 CluePoints standard (“optimized”) KRIs
  • 2 Additional study-specific KRIs as discussed and agreed in initial consultation
  • Access to the CluePoints Signals and Actions Tracking Management System
  • Up to 20 users

CluePoints Central Monitoring Platform Training

The RBM Starter Pack includes training on Central Monitoring Platform (CMP):

  • Introduction to the CluePoints platform, SMART engine methodology and how clients are using the solution
  • Demo of CluePoints including RACT, KRI dashboard, Signals & Action Tracking Management System, Patient Profiles, and overview of set-up process (for potential full solution use in future).
  • Access to the CluePoints eLearning Platform
  • Up to 20 users