Blog — Clinical Pathways

Now Available! ICH E6(R3) Comparison Tool. Includes Final Principles, Annex 1, and draft Annex 2. Click here to purchase.

ICH E6(R2)

New EMA Guidance: Quality Management of Electronic Systems

9/08/2020

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On April 7, 2020, the European Medicines Agency (EMA) released a Notice to sponsors on validation and qualification of computerized systems used in clinical trials. This guidance is applicable for clinical trials conducted in the EU and clarifies that even though a sponsor may delegate all or part of clinical trial activities out to a company, the ultimate responsibility for validation of software tools or electronic systems remains with the sponsor. This guidance also clarifies that most vendors focus on system security of the participant’s personal data, but they lack a focus on how an electronic system used in a clinical trial must comply with Good Clinical Practice (GCP) and the documentation principles of ALCOA+.

Live Webinar Risk Mitigation Changes with ICH E6(R3) and E8(R1) August 25th

8/18/2020

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Change is coming again. Expected updates to ICH GCP E6(R2) and ICH E8 support the agility and adaptability we need to reach the levels of study design, management, and conduct closest to the data and subjects. Taking these theoretical concepts into flexible, reliable, and accountable practices is the next step in more effective trials.

How Can We Work Together to Monitor Quality Source Data Amid COVID-19 Restrictions? Webinar

3/19/2020

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In the rapidly changing environment of COVID-19 restrictions, how can monitors and investigators ensure subjects and their personal health information remain protected and data remains high-quality? The ongoing challenge of site closures, travel restrictions, and social distancing has many unsure of how to proceed.

The Food and Drug Administration (FDA) released a finalized guidance document for conducting clinical trials during the COVID-19 pandemic. It clarifies…

Stuck at Home? Working Remotely? Use Your Time to Learn!

3/12/2020

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We are all busy, and now some of us are spending more time at home. All Clinical Pathways trainings are in an on-demand, interactive eLearning format for training when and where you need it. Instead of commuting, use your time to catch up on training!

Why Did Five Whys Lead Me Here?

3/03/2020

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You may be accustomed to using the Five Whys method for root cause analysis. You ask ‘Why’ five times in an effort to discover the root cause of an issue. If this is your go-to method, you may not realize that there is a different tool available or that Five Whys may be ineffective or outdated. After all, manufacturers of calculators at first had a difficult time convincing consumers of the value of a calculator when they were used to a slide rule. Could you imagine if everyone stuck to what they were comfortable with instead of trying something new?