Quality Assurance Principles

Purpose

Study 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 trial

· Define 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 compliance

· Describe 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 Plans

Content

Inputs to the IQRMP include but are not limited to:

· Clinical Development Plan

· Regulatory Strategy

· Risk Assessment and Categorization Tool

· Critical 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 IQRMP

Note: 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 Data

The 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 Table

Changes to Original Position Paper Text

Version 19Oct2016 2