(And why does that make enforcement hard?) What do the following companies have in common? Electronic data capture (EDC) software providers Central image / electrocardiogram (ECG) / spirometry readers Central clinical labs Electronic patient reported outcome (ePRO) software providers They’re not Clinical Research Organizations. That’s right. They’re not CROs. When you finish this, you’ll be… [Read More…]
Principle of Least Privilege: 5 Steps to Protect Your Company
Let’s explore the Principle of Least Privilege. What is it? What happens when it’s violated? And, we’ll map out 5 actions you can take to protect your company. You may need to pick up some new vocabulary. Why? Because it will help you have intelligent conversations with your clients and get better results for your company. My sad… [Read More…]
3 Tips for EDC Audit Trails
What follows is more or less a transcript of my presentation at the joint annual meeting of the San Diego Regulatory Affairs Network and the Orange County Regulatory Affairs Discussion Group on 19 Nov 2014. The 3 tips? 1) Use good password reset practices; 2) Don’t allow queries to fire until data are saved; and 3)… [Read More…]
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