Clinical Investigator Training and Site Staff’s Transcripts

Clinical investigator training as well as site personnel training has been part of the clinical research process for well over a decade now.  However, site personnel are constantly forced to retake training. This is because sponsors often do not recognize, nor do they have access to, completion credit for a given course or topic.

This problem benefits no one, with the possible exception of the training vendor.  It is costly for the sponsor and redundant and time-consuming for the site. It can also be confusing because not all content is accurate and up-to-date.

Several attempts have been made to try and remedy this issue.  Early attempts included sponsors standardizing training content and providing credit for course completion across studies and programs.  This helped, but it still did not address the cross-sponsor recognition of credit. Currently, attempts are underway to allow sponsors to recognize course completion.  These efforts are also flawed. They typically require sponsors to be part of the subscribed (fee-based) system.

There is a solution to the clinical research training credit problem. We must find a way to put the transcript back in the hands of the investigator (and coordinator). 

Many moons ago I attended college.  Actually, I attended several colleges.  Upon graduation, I received a degree and a transcript. One day, I needed a copy of the transcript that I had misplaced at some point.  Within one hour, I was able to receive a copy of my college transcript. The difference between my college transcript and site staff training records is this: I can control the transcript. I control who sees it, when they see it, and if they see it.

What’s the Solution

There is a solution to the clinical research training credit problem. We must find a way to put the transcript back in the hands of the investigator (and coordinator).  Also, there must be an accrediting body (like a college). By subjecting that body to some type of academic analysis to you can validate the content.  In doing so, sponsors can trust the site’s transcript and offer credit for the course.

We in clinical research should take a lesson from sales and marketing. There are plenty of accrediting bodies and standards to validate the content for Continuing Medical Education (CME).  Let’s adopt these standards and hold vendors accountable to them.

Passing control of the site staff’s transcript is an achievable goal.  Until then, all efforts to reduce the burden to the site will fail. Of course, there are colleges out there that refuse to recognize credits from another college, but that’s a blog for another day.

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