SOPs: How Many is Too Many?

Send us Fan Mail 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 la...