TMF Week 2021 - Day 2 - 1230PM PANEL: The Universe of Start up Records How do we make it easier?

What’s wrong with start-up and site records? For one thing, when it comes to sponsors and CROs, we overly interpret GCP. We don’t need to sign IBs, we don’t need to “approve” anything before shipping drugs to site, and goodness gracious, don’t archive the PI’s records - ICH E6R2, anyone? Moreover, we are not ensuring accountability and not remembering why we do what we do. Now, what’s right with the world? Well, during the pandemic, Human Heoes and Extraordinary Trialists continued to get clinical trials done. Let’s hear their perspectives and the ways they managed to not only carry on, but to do so with ink and paper. Let’s also hear from them about what they need to move faster and with better compliance. Let’s start our journey to EasyTMF. If you are a sponsor or CRO, today is your “call-to-action” day. We are incredibly pleased to close the second day of TMF Week with the voice of a Human Hero, Sharon Terry. I expect you’ll find her story as compelling as any you’ve heard.