Checklist for Clinical Operations Professionals and Risk Managers:

Focus on Critical Processes to Fast-Track Your Risk-Based Approach

Achieve a focused risk management faster and easier than ever before to enhance your Clinical Trial Efficiency
The ideal Walk-Through for processes and related records to consider all required aspects without overseeing any
Use your time and resources wisely and achieve compliance with ICH E6(R3) quickly

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The Checklist

is perfect for you, if ...

... You don’t have a Risk-Based Approach implemented yet.

... You are unsure of how to start your Risk Management process.

... You want to have a great starting point for Risk Management in your Clinical Trial.

... You don’t have time to identify your Critical Processes and Records.

... You want to have a comprehensive Checklist with all Critical Processes and Records for your Clinical Trial.

... You want to achieve compliance to the updated guidelines quickly.

What are you waiting for?

Get your checklist for your Clinical Trial!

Download your Checklist Now for 0 €Click here

Why do you need to identify Critical Processes and Records?

Why do you need a Risk-Based Approach for your Clinical Trial?

Read the references from the guidelines ICH E8(R1) and ICH E6(R3)...

Patient Safety: According to the ICH GCP guidelines, identifying critical processes and data is essential to ensure human subject protection and the reliability of trial results. This helps in minimizing risks to participants and maintaining the integrity of the data collected during the clinical trial.
Data Integrity: Also the FDA recommends that at the protocol design stage, sponsors identify the critical data and processes necessary for maintaining data integrity. This ensures that the data collected is accurate, complete, and reliable, which is crucial for the success of the clinical trial.
Quality Management: Implementing a risk-based approach to quality management involves identifying critical processes and data to focus on clinical trial activities that are essential for ensuring patient safety and data reliability. This helps in designing efficient clinical trial protocols and procedures for data collection and processing.

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About the Editor

My name is Jessica Cordes and for more than 15 years I have been working in Clinical Operations like you. When working for small biotech companies, I have been challenged as well with the evolving GCP requirements of the last decade.

You can ensure GCP Compliance with a Risk-Based Approach focusing on key activities – or keep running the risk of a future inspection finding.

In my Checklist, you will therefore find the Critical-To-Quality Factors of a Clinical Trial you need to comply with ICH E8(R1) and start your risk management process.

Do you have – like most Clinical Operations Professionals – no time or resources to implement a Risk-Based Approach?

Or do you simply lack the assessment of which aspects are critical for your Clinical Trial to start your Risk Management?

Then the Checklist is the right tool for you! Get started and secure your copy.