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A word of caution, when writing SOPs, they must adhere to what/how things are performed at your company; they are subject to Sponsor, Federal and State audits. If there are any deviations from what's written in the SOP, problems may arise. What I have done at our site is name this "Training Manual." Much less restricted, but contain all the necessary information to conduct a study at your site which follow GCPs and FDA requlations. Hope this helps.

Hello Patricia,
SOPs are pretty interesting. SItes and people have a tendency to want to write something to impress, but the reality is that the SOP should be what the staff are doing now, unless of course what they are doing is illegal or outside regulations and guidelines!
I always approach SOPs (having written them for numerous non-profits, private clinics and hospital research programs) as a straight forward fact finding mission. Once I know how the entity does things I review my knowledge on FDA, ICH, OSHA, Human resource law, and do additional research to see where there is room for improvement. Staff training is a crucial component to any SOP - if the staff does things differently than the SOP there is a problem!
A few folks have been kind enough to share their SOPs here at the ACRP website under the Resource Library - take a look to get some ideas but there is no one size fits all - never.
Best of luck with your new position!
Olivia Derridinger, MPA/Health, CCRC
Clinical Research Consultant