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)

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your go-to method, you may not realize that there is a different tool available or that Five Whys may be ineffective or outdated.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?

What Root Cause Analysis Tools are Effective?

1/19/2020

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SAM Sather and Keith Dorricott co-authored an article published in Clinical Leader entitled, “Clinical Trial Root Cause Analysis: Can't We Do Better Than Five Whys?” If you have experience with Good Clinical Practice (GCP), you may know that ICH E6(R2) now requires sponsors to conduct a root cause analysis (RCA) and implement appropriate corrective and preventive actions (CAPA) for noncompliance “that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results.”