Thinking about this hit home as we were trying to get a study started. Pivotal clinical trial, rapid start-up, site that’s targeting first subject first visit. Everyone’s on the same page and moving rapidly through the process of getting the study activated.
Then, along came the sponsor required portals for the study: EDC, IRB, IRT, central advertiser, training, Lab, SIP.
Seven portals that required all staff to be trained and have access to prior to site activation.
Just part of the typical study process you say? Here’s what these portals cost the site:
- PI – 5 hours
- Each sub-I (there are 2) – 3 hours each
- 3 hours each coordinator (x3), 1 hour each assistant (x2)
Total: 22 hours (I had to use a calculator. I didn’t want to get this wrong and get mocked) and this was just the time required before the study started. The portals impact each week throughout the study.
The site is already out thousands of dollars before the study starts. The staff is spending time gaining access to portals instead of seeing patients.
The only bright spot in all of this is that the site was using the VersaTrial study organizer. It saved considerable start-up time. Otherwise, I think the Principal Investigator would still be searching their emails for login links.
This study was just one example. The site costs are different for every study. If you don’t have a site plan to manage your portals, make one.
Clinical Research 
Stated well and with clarity. It amazes me how many research sites have no idea as to the cost of carrying this responsibility, and the varied issues that comes with multiple EDC systems, onboardong, and the multiple changes and retraining required that continues through the study time-line until data lock! This is something I was adamant about when negotiating a study budget, and renegotiating if the expectations increase and data capture changes to a significant degree while the study is on-going. I will definitely renegotiate a budget, and thankfully I’ve not had a Sponsor/CRO balk when budget adjustments are requested.
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