When we use a quality system designed for a manufacturing environment in a clinical trial, it can cause us to weigh risks inaccurately. We saw this in our post on procedures, where we noted that the resources, systems, and procedures in place to control SOPs are not used to support development of study-specific plans, which are a bigger risk for a clinical trial. The same is true of training.
One of the first systems purchased by any sponsor is a Quality Management System (eQMS) or Learning Management System (LMS) to manage SOP training. Meanwhile, each individual study team is left to manage their own study-specific training; within the study team, there may be different procedures in place to track CRO training, sponsor training, and training for other vendors.
Although some CROs have moved toward using their LMS for study-specific training, most are still using spreadsheets to define curricula, track assignments, and track training completion. This sounds simpler than it actually is. You need some fancy Excel formulas to determine training assignments using role-based requirements, effective dates of various versions of protocols and plans, and personnel start and stop dates. Some of the ugliest spreadsheets we've ever seen are training trackers, with garish color coding and cryptic symbols trying valiantly to bring order to chaos.
Meanwhile, many sponsors just don't bother to track their training. More than one team has explained during an audit that they're approving all the plans, so they don't need to be trained on them. As the study rolls on, of course, the plans are updated, the sponsor team grows, and soon no one can prove that the new Medical Monitor ever saw the Investigator's Brochure.
The average clinical trial has about 30 different protocols and plans, each of which is amended on average five times. For a global study with 300 team members, with each team member training on half the items, that's over 22,000 training assignments.
This is what we mean when we say we're weighting risk incorrectly. Small biotechs with 100 employees routinely purchase a QMS or LMS to manage roughly 1000 - 2000 training assignments a year. Meanwhile, each of that company's clinical studies is managing 5000 - 22,000 training assignments by hand. The risk of not following a protocol or study-specific plan is arguably higher than the risk of not following a high-level SOP, but because manufacturing doesn't have this category of procedures maintained outside the QMS, we don't have the mindset that this is a risk we need to mitigate.
