Got an offer to support 28 Phase II oncology sites with quarterly remote SIVs on Teams and no routine on-site visits; my current role covers 14 sites with in-person SIVs and monthly compliance touchpoints. I’m concerned that stretching coverage like this could degrade protocol adherence and timely SAE reporting — anyone running this model without compromising GCP or patient safety?
I ran 26 Phase II sites remotely last year; it worked, but only because we set hard guardrails… We used a ‘pre‑SIV readiness checklist’ and a weekly 15‑min safety huddle with PIs — any EDC lag >72h or unacknowledged SAE >24h auto-triggered an extra review or pop-up visit; without that, you’re herding cats over Teams. If they won’t fund occasional for-cause on-sites or a co-monitor, 28 is dicey.
Going from 14 to 28 with quarterly Teams SIVs, I’d add a standing 10‑min weekly SAE check for the first 8 weeks post‑activation, then biweekly, and require a 24‑hour “zero‑SAE” confirmation from CRCs every Monday. @farley_j77’s huddles helped us, but the kicker was a trigger: >2 late SAEs or >5 overdue safety queries in a month = ad‑hoc visit (remote or on‑site if budget allows). If the sponsor won’t accept the trigger, I’d push back because “no routine on‑site visits” works until a high‑enrolling center slips.
I’ve run 30 Phase II sites with quarterly Teams SIVs and made activation contingent on EMR/eReg viewer access — “no remote source = no go‑live” — so I could review the first 3 consents and first dose notes within 48 hours. , the only way it held up on SAE timeliness was a trigger rule: if query aging hit 5 days or a missed AE assessment popped up, that site flipped into a 72‑hour AE/SAE reconciliation cycle until clean. If they won’t grant true remote source or a PI coverage schedule with after‑hours escalation, @OP I’d negotiate a smaller cluster or bake those requirements into the offer.