Today

Auto-drafted protocol v0.1-auto for study "GAL-001: Adaptive Phase II in Refractory Melanoma" needs medical review. Predicted amendment risk: 0.81 — 6 SPIRIT checklist item(s) unresolved (items missing at v1.0 drive avoidable amendments): trial registration (SPIRIT 2); study design (SPIRIT 8); outcomes (SPIRIT 12); sample size with assumptions (SPIRIT 14); interim analyses and stopping rules (SPIRIT 21b / OCTAVE); harms plan: AE collection, coding dictionary, safety population, harm stopping criteria (SPIRIT 22 / Phillips 2019).

Feasibility score 0.45 for "GAL-001: Adaptive Phase II in Refractory Melanoma" (US) is below threshold. Confirm or revise the study footprint.

Feasibility score 0.0 for "GAL-001: Adaptive Phase II in Refractory Melanoma" (EU) is below threshold. Confirm or revise the study footprint.

Auto-compiled IND amendment for GAL-001 is ready. Regulatory affairs must approve before submission to FDA.