I would be reluctant to write an SOP for such a nebulous concept. In spite of the FDA Guidances on RWD/RWE, there is much to learn about what it all means. A proper SOP requires lack of flexibility in interpretation and execution. So, am not sure how you can write an SOP in that context.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 30-Dec-2021 11:45
From: Anonymous Member
Subject: Non-interventional study SOP (RWD/RWE)
This message was posted by a user wishing to remain anonymous
Dear All,
My company would like to create a separate SOP covering non-interventional studies. The FDA's guidance document released this month, Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products, lists regulatory considerations including transparency regarding data collection and analysis, RWD data access, study monitoring (reliability and data integrity), safety reporting, and electronic systems. I realize there will be overlap with our procedures for interventional studies.
- Do you have a separate SOP in place for non-interventional studies?
- If so, how have you incorporated the regulatory considerations the FDA outlined in the guidance document?
Thank you!