Review of Your eTMF Against ICH E6 R2; A Case for Compliance

Review of Your eTMF Against ICH E6 R2; A Case for Compliance

Use TAKE Solutions’ Assessment to Save Your eTMF

With growing demand from the public and regulators for better clinical research results, the clinical landscape continues to grow more challenging. The estimated research and development cost for a drug to hit the market currently sits at $2.5 billion – which pushes sponsor companies to complete trials on time and on a budget more than ever.

One response to this rising cost is the recent update to the International Council of Harmonization (ICH) Good Clinical Practices (GCP); this update requires predictive and proactive models in a risk-based approach to quality management for trials. The goal is essentially to enhance operational quality, efficiency, and patient safety.

TAKE Solutions has released a proven ICH E6(R2) framework to determine compliance that is easily customized for any organization’s culture, objectives, and structure. Covering the major areas that are addressed in the new regulation including data integrity, operating model and risk-based monitoring, SOP updates, and more, the assessment looks at key areas of your FTP system to find and resolve compliance issues.

How would your eTMF fare against this assessment?

Areas Covered to Bring You into Compliance

TAKE Solutions’ framework is designed to ensure that processes and technology are working to provide your team with the support necessary to be compliant with the new update. In addition to processes and technology, it also includes strategy and organization as focus areas.

Further breakdown divides these four areas into eight sub-areas:

  •         Quality Management & Risk-based Approach: Addresses variabilities and inefficiencies along the clinical trial value chain by incorporating Quality by Design (QbD).
  •         Data Integrity & Analysis: These principles emphasize successful risk assessment and data quality – the foundation for a successful clinical trial.
  •         Operating Model Design/Redesign: Develop new strategies while taking into account people, technology, and processes.
  •         Governance Model Design: Site quality control is addressed, along with predictive and proactive risk assessment.
  •         Risk-based Monitoring (RBM): The development of a systematic, prioritized approach to monitoring clinical trials is required of sponsors.
  •         Quality, Compliance, and Regulatory SOPs: Updates to this category is the most crucial part of achieving compliance.
  •         Electronic Sources: Next-gen technology is an essential factor for quality risk management.
  •         Advanced Automation Tools: Solutions like ePRO, EDC, and others allow aggregation of data seamlessly, linking and integrating it all to generate models and analytics to accelerate trial progress.

The Benefits of Comparing Your eTMF Against the ICH E6 GCP

Assessing your trial master file with the ICH E6 GCP provides a clear view of not only what is required to be in compliance, but also what areas your TMF has that need attention. All SOPs, templates, and documents are reviewed and detailed descriptions of gaps between procedures and current requirements are outlined. Results include a roadmap for changes that must be made in order to be in compliance, along with feedback regarding a strategy for success.

Your team will greatly reduce its inspection risk and improve internal and external communication with a clear, credible roadmap after the assessment is complete. Scarce resources to prioritize systemic risks can be more efficiently used, and continuous improvement in overall processes and systems relating to the TMF are facilitated, as well.

New requirements as a response to the increasing demand by the public for better clinical trial outcomes means your TMF protocols have to be at the top of their game like never before. Ensuring that your TMF is up to par with these new regulations is the best way to avoid potentially devastating consequences from a poorly kept eTMF when an inspector or auditor shows up at your organization.

Find out how to manage the latest updates and news about trial master files at our upcoming TMF conference; seating is limited, so sign up today before the summit is full.


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By |2019-06-20T20:53:07+00:00June 12th, 2019|

About the Author:

Byron Mignanelli

Experienced business leader with a proven track record of success as an entrepreneur, CEO and business unit leader. Demonstrated success at building highly effective sales and marketing teams that deliver above market returns.

10 years experience developing, launching and executing leading business management conferences. Directly involved with marketing strategy and execution for over 40 new executive-level industry events within multiple management functions and industry segments.

Deep market knowledge of management and industry trends, ability to synthesize large amounts of data, uncover new markets and produce measurable financial results.