Professional Documents
Culture Documents
SOP's: The 5 W's and One H
SOP's: The 5 W's and One H
Example disclosure:
Why are SOP’s important?
• Consistency
• Research quality & integrity
• all research being done follows ICH GCP, and institutional
policies to protect the rights and welfare of human study
participants.
• Written documentation of proper procedures
Why are SOP’s important?
(cont.)
• Toolbox for staff
• Documentation of staff training
• Can be used to standardize your practice
versus adapting to every sponsor’s requests
• Can be a pitfall if not followed
– If you have SOP’s you are expected to follow them
– You don’t what an FDA finding that you didn’t’
follow your own procedures
How to establish SOP’s for your group?
• Identify your needs
• Divide by functional groups
– Study Coordination, Regulatory, Data Mgmt…
• Make a plan
– Team approach?
– Lead author?
• Draft Ideas
– Outline relevant categories
– Outline steps
How to establish SOP’s for your group?
(cont.)
Thank you!