I R M A TM

Intelligent Risk Monitoring Assessment TM

Risk-based Approach to Clinical Trial Monitoring

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About IRMA TM

The first fully integrated monitor visit assessment tool that utilizes the information from the monitor visit report to: score and assess site performance, assess site and study risks, provide corrective action plans (CAPA) based on site assessment scores and perform trend analysis at site, regional and study levels.

IRMA TMComponents

Incorporates FDA Guidance’s on Risk-Based Monitoring (August 2013)

Risk-Based Tool Components IRMA™ Model
Ability to Perform Study Level Risk Assessments
Ability to Perform Site Level Performance and Risk Assessments
Ability to Focus on Critical Study Parameters
Ability to Review Risk Trends at the Site and/or Study Levels
Provides Mitigation & Corrective Action Plans
References Global Regulations: ICH/GCP, FDA CFR, EU Directives
Assists in Identifying Protocol & Regulatory Non-compliance’s
Risk-based Monitoring Report – Tailored to Study
Identifies Remote and On-site Monitoring Requirements
Ability to identify and focus monitor site visits based on actual risk scores achieved for Particular area(s) of the monitor report.
Incorporates IRMAs Risk-Based Monitoring Plan

IRMA TMComponents

The Risk-Based Monitoring Report Tool

Because the CRA is the:

  • first to assess site performance &
  • ‘first line of defense’ against data discrepancies &
    protocol non-compliance from clinical trial start-up to
    close-out
  • It makes sense to utilize IRMATM to promote early
    identification and continuous assessment of clinical site
    areas of risk and improvement.

    With IRMA TM:

  • Monitoring activities are driven by the risk criteria and
    risk score achieved within the monitoring report.
  • Results can be used to support data management metrics
  • Encourages interdepartmental risk communication
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    IRMA TMReport Integration

    Utilizes actual assessment information from the Monitor Visit Report to provide:

    Early and Ongoing detection of Study and Site level risks

     

    A means to Identify and Grade Study and Site risks to allow for corrective action planning

     

    Provides early detection of Site and Monitor training needs

     

    A means to Identify when 100% or <100% SDV is recommended

     

    Monitoring references to ICH/GCP, FDA CFR and EU Regulation/Directives.

     

    A Project Risk Management Tool at Clinical Monitoring and Investigative Site Levels

     

    Performance and Trend analysis at both a Study and Site level

     

     
     

    IRMA TMKey Features

    Key features of Monitor Visit Risk Assessment Tool

    • Risk Based Monitoring Plan

      Incorporates FDA recommendations for components of the Risk-Based Monitoring Plan and can be incorporated into a company monitoring plan template or used as a stand-alone monitoring plan.

    • Master Risk Assessment Table

      Available at the Study and/or Site levels. Serves as a master risk management document for the study manager and clinical research associate (CRA).

    • Risk Assessment Status Report

      Available at the Study and/or Site levels. Captures and provides graphic details of Study and/or Site risks identified for an assessment or as identified over several assessments allowing for trend analysis of both Study and/or Site level risks.

    • Risk Assessment Report

      Is an intelligent monitor visit report that serves as a visit report, educational tool, training tool, regulatory reference tool, risk assessment tool and corrective action plan tool all in one.

    • IRMA TMKey Features

      Centralized and Triggered Monitoring

      IRMA’s ability to tell the monitor when on-site and/or remote monitoring can occur combined with identifying which data to review/verify, allows the CRA to focus on critical areas of risk, saving on Monitoring time and costs related to monitoring activities for areas of low or non-critical risk.

    • ON-SITE & REMOTE MONITORING

      On-site & Remote monitoring activities are determined by the sites’ average risk score

    • SOURCE DOCUMENT REVIEW & VERIFICATION (SDR/SDV)

      Source document review and verification (SDR/SDV) can be focused on report sections that indicate site risk

    responsive devices

    Process Flow

    responsive devices
    responsive devices

    Risk Assessment Scores & Color Coding

    Each risk assessment is assigned a score of 0 to 5 (0 represents no risk; 5 represents severe risk).

    Each score is color coded to quickly identify site risk.

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