Integrated Quality and Risk Management Plan (IQRMP)



Integrated Quality and Risk Management Plan (IQRMP)PurposeStudy quality is a shared responsibility across all functions involved in collecting, analyzing and reporting clinical trial data. The IQRMP provides a tailored and integrated plan for a specific clinical trial that will:Include the clinical and medical risks identified at the program level Define the actions that each function will take to proactively identify, assess, and manage risk throughout the life of a clinical trialDefine the critical data variables identified by cross – functional representatives (e.g. elements and/or processes that impact primary efficacy endpoint and critical safety parameters) Align associated quality management plans (including the monitoring plan) across identified risks and defined critical data variables, so that cross-functional teams can focus on the risks that are most important to patient safety, data integrity and regulatory complianceDescribe the process that all functions will follow to review and revise the IQRMP throughout the life of the program and clinical trial(s)The IQRMP is not intended to duplicate the content of existing functional plans; these can be linked or referenced within the IQRMP so that the accountability remains with the relevant function. IQRMP including the RACT, Critical Data, Risk Indicators and Various Functional PlansContentInputs to the IQRMP include but are not limited to:Clinical Development PlanRegulatory StrategyRisk Assessment and Categorization ToolCritical Data Any existing program or product risk management plans The IQRMP is graphically depicted above. The procedures and activities described within the IQRMP should not duplicate Standard Operating Procedures or other documented guidance. The IQRMP should describe the trial specific actions/processes that will be implemented to focus on the specific risks and critical data variables identified.It is recommended that the overall accountability for the development and maintenance of the IQRMP is assigned to a centralized function such as project or program management to ensure that the key elements are aligned across all functions.Recommended / Potential Risk Elements within the IQRMPKey Elements of the IQRMPDescriptionLocation(Provide link to document locations)Critical Data & ProcessesDefines and documents the agreed critical data/processes for the protocol. Typically stems from the study’s objectives and data used to make decisions around the IP’s safety and efficacy profileRisk AssessmentDefines program and/or project level errors (risks) which could affect patient safety, data integrity or regulatory compliance; while considering the impact, likelihood of error (probability) and the extent to which the error would be detectableMedical Monitoring PlanDescribes clinical science/medical monitoring data review and cleaning activities Safety PlanDescribes how pharmacovigilance/drug safety will manage safety risks related to a product Data PlanDescribes the procedures for data collection/review/cleaning Statistical Analysis PlanDescribes the procedures for executing the statistical analysis of the primary and secondary variables and other critical dataMonitoring PlanDescribes the remote/offsite and on -site monitoring activities based on the identified risks. Includes risk indicators (triggers) that will help to drive decisions on the type of monitoring to be conductedTraining PlanDescribes what trial specific training will be provided to all parties involved in the clinical trial, (e.g. study management teams, monitors, investigator sites and vendorsQuality PlanDescribes quality assurance/management activities. Provides tools and materials to ensure compliance to regulatory requirements and inspectionsOther Functional PlansRisk Management LogA tool that can be used by the cross functional team to track and monitor the progress and actions relating to identified risksNote: Elements contained with this table are examples. Each sponsor will select which plans are appropriate for their company and include links to those functional plans in the right column.Risk Assessment Categorization Tool (RACT)It is recommended that the baseline RACT output and any revisions are maintained and documented. Example – Overall study categorization risk level may be documented here with the full RACT output as an appendix or using Revision History of IQRMP, changes to RACT may be tracked. Critical DataThe identified critical data for the monitoring of risk mitigation should be documented. An example on how to capture this data is below.Example Critical Data TableeCRF or Module NameVariableInstructions (optional)Changes to Original Position Paper TextVersion DateKey Changes19 February 2013Original19 October 2016Deleted Revision History and Approval Section sample tables and associated textAdded Risk Assessment and description line in IQRMP tableAdded “and processes” to Critical Data references Diagram updated; removed IB and Protocol boxesVarious minor clarifying text added in comparison to the original position paper ................
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