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Published in Clinical Researcher. Imagine this: On your first day of work, your supervisor slaps a fat copy of the great Russian novel War and Peace on your desk. "You have 30 days to read this," she says. "Don't let any other deliverables slip. And by the way, there will be a quiz on each chapter." Sound familiar? Substitute standard operating procedures (SOPs) for Tolstoy, and you'll find it's happening in clinical departments worldwide. Count them up, if you can stand the shock: Some of you are required to train on more than 1,000 pages of SOPs biennially. The only difference between the two scenarios is that War and Peace has an interesting plot, whereas, your SOPs? Not so much. Long, but Not Lean The last few years have seen two alarming trends: The number of quality documents that clinical research personnel train on is increasing along with the length of those documents. A training curriculum of 100 SOPs at an average of 15 pages each is not unprecedented. Why, when so much of the industry is embracing lean methodologies,1 do you have so many long SOPs to read? The phenomenon seems to arise from a few different factors. First, in smaller companies that are ushering their first products into the clinic, there is the influence of quality personnel trained in Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). Both GMP and GLP mandate SOPs that are detailed enough to use without supervision or supplements—an approach that does not...Read More » View All Articles
When it comes to FDA investigations, face it: You're outmatched. The investigator conducts an investigation every day of the week, while for…Read More »
Halloran's annual Clinical Operations Retreat (CORE) 2016 will take place September 28 - 30, 2016 at Ocean Edge Resort &…Read More »