Ensure Compliance with ICH E6 (R2) using a Risk-Based Approach

The Risk Assessment & Mitigation Planning (RACT) Starter Kit has been designed to allow clinical development organizations to quickly and effectively implement an intuitive and configurable tool for risk planning in a single study or across multiple studies. CluePoints RBM experts will guide users through the process of selecting appropriate risk assessment questions along with the categories to which they apply. Full training will be given on how to use the CluePoints RACT tool to assess the risk and identify risk mitigations during pre-study planning and throughout study conduct.

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.

Risk Assessment (RACT) Starter Kit

The RACT Starter Kit includes 2 Configured RACT Profiles within the CluePoints Platform:

  • 1 Standard RACT Profile as recommended by TransCelerate
  • 1 customer-specific/study-specific RACT resulting from the initial consultation
  • 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.

Risk Assessment (RACT) Starter Kit

The RACT Starter Kit includes 2 Configured RACT Profiles within the CluePoints Platform:

  • 1 Standard RACT Profile as recommended by TransCelerate
  • 1 customer-specific/study-specific RACT resulting from the initial consultation
  • 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