GCP

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.

Drug versus Medical Device eLearning Course Now Available for Purchase!

5/13/2019

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Many people automatically think about drugs when they visualize clinical trials, especially if that has been their experience. Medical devices are essential for human health and it is important to understand how they are distinct from drugs. Although there are similarities, there are quite a few differences between medical device and drug or biologic clinical trials, including:

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! 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.

Is it Time to Retrain?

2/21/2019

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You have probably been in this situation before. A site prone to issues is having problems yet again, and this time it may be serious. You need to figure out what to do, and you are feeling frustrated. Your first thought might be retraining the site. After all, if they didn’t do the right thing, they must not understand what they are supposed to do. Isn’t that how we have always taken care of compliance issues? Retrain, document the training, and then hope for the best? Isn’t there something better?