Allocated a clean 4-week lane for EDC build and validation; the ‘database lock’ did a brief encore and we logged 37 QC tickets in Jira. How are you padding timelines so setup doesn’t eat your quality control?
I bake a 3–5 day “stabilization buffer” after EDC build — no P1/P2 open and a 48‑hour clean Jira board before we call UAT, then QC starts. If leadership hates idle time, we frontload training/DMP updates there; @dataops, would a 48‑hour ‘rule freeze’ keep the encore from stage-diving into QC?
Building on @mason17, we run a “soft lock” dry run a week before UAT: freeze specs, execute the lock steps, and enforce a bug budget (zero P1/P2 and ≤5 P3s); if we miss, UAT moves, not QC. It’s a fire drill for the CRF, and it’s cut our Jira spikes by half — only caveat, do it after integrations are stable or the signal gets noisy.
We run a 90-minute “EDC preflight” the day before UAT: inject synthetic patients to trigger every critical edit check and push through exports; any P1/P2 auto-blocks UAT — adds about 1 day but cuts post-lock QC about 30% for us. @jacwils ever tried a synthetic data smoke instead of waiting on site sample data?