In this discussion, Edye Edens and Darshan Kulkarni tackle one of the most common questions in clinical research: How many SOPs should a site have? While many assume a fixed number like 12, the reality is more nuanced.

From a site perspective, having extensive SOPs can feel overwhelming, but they are essential for compliance and audits. SOPs are the first thing requested during inspections by the FDA or sponsors. However, sites must strike a balance—too few SOPs indicate a lack of structure, while too many can create unnecessary complexity.

For IRBs, SOPs are a given, as they must document their policies for both internal staff and external researchers. 

Sponsors and CROs also rely on SOPs to ensure patient safety and regulatory compliance. They don’t necessarily need extreme detail, but they do need a clear framework to verify consistent procedures.

Key takeaways:

• SOPs should set a structured, repeatable process—not be reactive documents.
• Having too few SOPs signals weak compliance; having too many leads to contradictions.
• M&A buyers and private equity firms look for strong SOP structures when acquiring research sites.
• AI and shared templates can help, but SOPs must be customized and regularly updated.

For new sites, a starting range of 5–10 SOPs is reasonable, expanding to 10–20+ SOPs as operations grow. Ultimately, SOPs should be strategic, practical, and tailored to the site's needs—ensuring compliance without unnecessary burden.

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