2025 SCRS Global Site Solutions Summit: How to Streamline Site Qualification and Initiation Training

In a video interview on-site with Applied Clinical Trials at the 2025 SCRS Global Site Solutions Summit, Christine Senn, PhD, SVP, site-sponsor innovation, Advarra, discussed the inefficiencies in training within the clinical research industry, highlighting the redundancy and lack of transferability of training across therapeutic areas. She advocated for a more effective use of adult learning principles in site investigator visits (SIVs), suggesting that extensive training on patient enrollment and randomization is crucial, as these initial steps set the foundation for the entire study. Senn also discussed Advarra’s latest initiative, which aims to streamline the process of creating confidential disclosure agreement (CDAs) by addressing inconsistencies within subgroups.

ACT: How can site qualification and initiation visits be streamlined without sacrificing protocol training or compliance?

Senn: I have a lot of thoughts about training, because there is so much redundancy. I was talking to a sponsor earlier today, and one of their initiatives is that if you've ever been on that sponsor's trial within the past two years, any training you have across any therapeutic area, as long as it's the same training, counts, which is great, because we know that in a bigger sponsor company, sometimes the therapeutic areas are siloed a little bit. That was a fantastic one. There's also, I think, we can look at what just doesn't need to be redone. If someone is a certified principal investigator through ACRP, do they really need to do certain GCP training again? Or is there GCP training already on record for a coordinator, anything like that?

One of my pet peeves is really just that there's not a lot of adult learning principles used in SIV training. s an example, everything you need to know as a site, as a site person, whatever it is, is how to enroll a patient appropriately. They meet all the criteria. What's very unique about the patient population, about the enrollment visit, about the screening procedures, the randomization visit? You have to know that perfectly, because that sets up all your endpoints for everything, good qualification, and washout period maybe. You do not need any training at SIV beyond that, because every single visit from there is, first of all, too far out in a lot of cases, but also, you never do more than you did at enrollment and randomization, because those endpoints carry through to the end of treatment. The end of treatment is usually a repeat of randomization, so let's train on the really hard things, and I promise you, the person can then figure it out.