Q: Are Standard Operating Procedures (SOPs) required for clinical trials?
A: The short answer is, surprisingly, no.
While the FDA, of course, expects SOPs to be created and followed by clinical research sites, the Code of Federal Regulations (CFR) does not specifically note SOP requirements for sponsors or clinical investigators. The only mention of similar requirements in the CFR pertains to IRBs, requiring that they “…follow written procedures…” (21 CFR 56.108) and that “…the records required by this regulation…be retained…” (21 CFR 56.115(a)(b)).
In addition, ICH GCP guidelines also include no reference to a requirement that clinical investigators maintain SOPs.
However, ICH GCP guidance and other compliance-related documentation do set expectations that sponsors and CROs maintain and follow SOPs.
And if sponsors and CROs need to follow SOPs, so do sites. While sites may not be legally required to do so, conducting clinical research without well-defined and documented SOPs is not in the best interest of any of the parties involved.
In addition to having detailed SOPs in place, test them! Have site personnel take each SOP for a test run to ensure they are accurate, easy to follow and include all necessary details.
Disclaimer: This article and the SCRS website are public resources of general material and do not constitute legal or professional advice.