SOPs: Why Do We Do What We Do?

Why do we write SOPs the way we do?

We in clinical development have inherited the philosophy, structure, and even format of our SOPs from our forebears in manufacturing and laboratories. On the manufacturing floor or in the lab, adherence to specifications is the goal. Tasks are repeated frequently, so to ensure continued adherence, each repetition of the process must be an exact copy of the previous.  Thus, SOPs are designed to promote adherence, consistency, and interoperability.  SOPs must be written so that

• A user can execute all steps of the process based on the information in the SOP
• Executing the steps as written will achieve a quality result
• Any user following the SOP will complete the task in the same way and with the same result

Manufacturing and lab SOPs assume nothing.  They include all required steps, anticipate all contingencies, are presented chronologically, and include all relevant definitions and references.

Clinical development is a different environment.  A clinical study includes hundreds of processes executed by hundreds of people. Within most processes, variation is acceptable, or even encouraged – the much vaunted “risk-based approach.” For example, a monitoring visit in an oncology study may look different than a monitoring visit in ophthalmology, but two consecutive monitoring visits in an oncology study may also be different – we rely on site monitors to assess the situation, use their judgment, and adjust their approach to address the risk.

If clinical trials are so different from manufacturing, why do we use GMP-style SOPs to manage them?

Most sponsors and CROs have modified the manufacturing/lab SOP paradigm to permit more flexibility, but we still cling to the relics of the paradigm, such as long Responsibilities sections, exhaustive Definitions sections, and step-by-step instructions that don’t fit all use cases.

What if we designed SOPs from the ground up to fit our needs and objectives?  Our next blog post will explore how we can incorporate a GMP-based quality approach without the complexity that makes GMP-style SOPs so hard to use.