We’re aligning our SOPs to the May FDA DCT guidance, with a focus on documenting investigator oversight for remote assessments and direct-to-patient IP shipments. To support recruitment without protocol drift, we’re piloting eConsent identity verification and adding a 24-hour source upload requirement for home health visits. How are other sites adjusting delegation logs and monitoring plans to balance enrollment targets with audit readiness?
We added a ‘remote assessor’ line on the delegation log and an auto-prompted PI oversight note to review all tele-visits weekly; for DTP IP, we require courier proof plus a photo of the sealed kit uploaded to source on delivery. Small caveat: a strict 24-hour upload can punish after-hours home visits, so we use next-business-day by 9 a.m. for anything after 6 p.m. — keeps compliance without turning the PI into a 24/7 webcam; guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials.
It sounds like a solid plan with the new eConsent identity verification. We found that requiring patients to upload a photo ID during that process has significantly reduced verification issues for remote assessments. I’m curious if you’ve considered how that might impact your enrollment timelines?
I love the idea of eConsent identity verification — it’s like having a bouncer at the club! We’ve been doing something similar with our telehealth visits by requiring not just a photo ID but also a quick verification call. It adds a layer of trust, though it can be a bit of a pain for patients sometimes.