Blogs about: Gcp Sops
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What’s the difference between protocol deviations and violations according to GCP?
Is the difference between a protocol deviation and a protocol violation a matter of interpretation, or does GCP provide an answer? Real world or ideal world? In an ideal world, protocol violations wou… more →
sopwriting
What's the difference between protocol deviations and violations according to GCP?
— 2 comments
wrote 2 years ago: Is the difference between a protocol deviation and a protocol violation a matter of interpretation, … more →
SOPs: recipe for organisational effectiveness or effective-mess?
wrote 2 years ago: Are your SOPs overly complex? Have you ever wondered whether there’s a straightforward relationship … more →
What SOPs do sponsors need to demonstrate GCP compliance?
wrote 2 years ago: The need for SOPs in ICH-GCP (5.1.1) is clear: “The sponsor is responsible for implementing and main … more →
7 reasons to make Standard Operating Procedures (SOPs) user-friendly
wrote 2 years ago: In clinical research, the need for Standard Operating Procedures (SOPs) is enshrined in the 13th pri … more →
What tools do you use to develop your Standard Operating Procedures?
wrote 2 years ago: Image via Wikipedia Over the years, I’ve noticed that organisations have one thing in common … more →
Do your SOPs make sense?
wrote 2 years ago: Too many acronyms? In my last post, I asked the question: do your SOPs make sense? Recognising that … more →
In clinical research, is there a difference between guidance documents and SOPs?
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wrote 2 years ago: Image via Wikipedia I often come across perceptions of SOPs as formal (“boring”) must fo … more →
