Proven techniques for process improvement, like Lean Six Sigma, say that if you identify waste in a process, you should remove it by standardizing and controlling as much as possible. These improvement techniques were born from efforts to make production lines more efficient, and produce as many identical products as possible in the shortest amount of time.
But unlike most initiatives, the goal of the protocol process is to produce a single unique protocol at the right quality at the right time. It’s also usually a one-time activity for an individual trial team. So while some degree of control and standardization is necessary to reduce the time it takes to produce the final output, applying too many controls can, in fact, be counterproductive.