More Time to Comment on Electronic Health Information Proposed Rules

5/16/2019

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The Department of Health and Human Services (HHS) is extending the comment period until June 3 for two proposed rules related to electronic health information and applicable to clinical trials. The HHS Office of the National Coordinator for Health Information Technology (ONC) has also released the second draft of the Trusted Exchange Framework and Common Agreement, which supports the exchange of electronic health information nationwide.

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:

Introducing the DIGR-ACT® Solution! Part 3

5/07/2019

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What does ‘G’ stand for?

W. Edwards Deming said, "If you can't describe what you're doing as a process, you don't know what you're doing!" Many people don't naturally think of work as a process, but thinking of it that way can help you uncover what might be an earlier cause of something going wrong. Maybe your normal process for grocery shopping is to write a shopping list and take it with you to the grocery store to make sure you get all the items. But today, you get home and realize you are missing several items you needed.

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.”