ICH E6 R2

ICH Releases E8 “General Considerations for Clinical Trials” Draft Revision for Public Comment

6/11/2019

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Clinical trials have become increasingly complex since the ICH E8 guideline on “General Considerations for Clinical Trials” was finalized in 1997. The draft revision is in Step 2b and available for public comment, and there are some interesting changes to note. Specifically, there is a greater emphasis on patient centricity, design of trials with quality in mind, and risk management. The overlying theme is fit-for-purpose quality as an essential consideration for study design. The revision is part of the Good Clinical Practice (GCP) Renovation initiative. Previously, the ICH E6 GCP R2 addendum was finalized in 2016.

Can You Dig Down to the Root Cause?

4/30/2019

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You have probably heard about the changes to the ICH E6 GCP, the R2 addendum, and that it impacts clinical trial oversight. One particularly important section added was in ICH E6 (R2) 5.20.1: “If noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.”

Exciting News! Good Documentation Practices eLearning Course Now Available for Purchase!

4/23/2019

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We are excited to announce that interactive eLearning courses are now available for purchase in our Clinical Pathways store, with more courses coming soon! All courses are available at a special introductory rate through April 30th.

One of our key eLearning courses is our interactive good documentation practices training, which includes ALCOA-C, notes to file, and other general good documentation procedures, updated with the latest from ICH E6 (R2) Addendum. This course includes:

Exciting News! GCP eLearning Course Now Available for Purchase!

4/02/2019

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We are excited to announce that eLearning courses are now available for purchase in our Clinical Pathways store, with more courses coming soon! All courses are available at a special introductory rate through April 30th.

One of our key eLearning courses is our Good Clinical Practice (GCP) training, updated with the latest from ICH E6 (R2) Addendum.