As monitors, we often encounter sites that utilize Standard Operating Procedures (SOPs) to help ensure clinical research trials are consistently conducted according to FDA regulations. According to the International Conference on Harmonisation (ICH), SOPs are “detailed, written instructions to achieve uniformity of the performance of a specific function.” While most would not argue the value of SOPs when it comes to the successful completion of a clinical trial, it’s important to take a closer look and think about them critically prior to implementation.
Perhaps too often people with the best intentions create SOPs without taking the time to really think them through and ensure they meet the desired goal for which they are intended. An example might be when a site mistakenly uses an outdated version of a consent form and rushes to create an SOP to ensure it does not happen again. Unfortunately, if it is not well-written, it actually would not do much to prevent a reoccurrence. Or, if training on the new SOP is not provided and staff is not aware of the new procedure, nothing would change. Even worse, the site could have a false sense of security related to their informed consent process because they have an SOP.
Another common issue that occurs is when overly stringent SOPs with lofty expectations are put in place. In this case, the best intentions can then lead to unnecessary chaos over not following the SOP. An example might be a study that has an SOP which requires the principal investigator (PI) to electronically sign all changes that take place in the electronic data capture system. As you can predict, it will be highly unlikely that all of the PIs across a multi-center trial will manage to accomplish this feat. The end result winds up being a lot of unnecessary commotion over this not occurring, especially since there is no regulation that specifies that level of scrutiny to ensure proper oversight.
Another common pitfall to avoid when it comes to SOPs is when a site places their SOPs above sponsor requirements, IRB policies, and/or FDA regulations. It would be a mistake to conform to an ill-prepared SOP that is actually counter-compliant to enforceable regulations. An example might be that a site creates an SOP for reporting serious adverse events. After reviewing all of their protocols, they find that a compliant deadline would be to state that all serious adverse events will be reported to the IRB within five working days of knowledge, regardless of protocol requirements. However, after implementing the SOP, it is noted that the IRB requires all serious adverse events that are also related and unexpected be reported within 24 hours. If the site waits the “allotted” five working days for these exceptions, they will be non-compliant with the IRB requirements, and therefore not compliant with the federal regulations.
Which begs the next question, are there any regulations that require sites to create and use SOPs? Despite the FDA using SOPs themselves, you may be as surprised to learn that they are only a codified regulation for nonclinical testing (21 CFR 58.81). However, should a site choose to institute an SOP then they feel obliged to follow it or they will be in non-compliance with their own internal policies. While no sites wants this to happen, they actually would not be in non-compliance with FDA regulations if it should occur.
Could you imagine a scenario when it might be better not to have an SOP? Do you think SOPs are worth having at the site level? We’d love to hear about your opinion as well as your experiences with sites and their adventures with SOPs.
Photo Credit: cristinabe