AIRCHILL Clinical Investigation Package
Clinical operations · document control
AIRCHILL Clinical Investigation Package
A controlled development package for the cardiac-arrest and ischaemic-stroke programmes. Each module is designed to be converted into sponsor-controlled documents for ethics, competent-authority, notified-body and FDA interaction. Pages are development drafts and do not replace signed, version-controlled regulatory submissions.
Core programme documents
Full Clinical Investigation Plan
Objectives, design, population, intervention, schedule, endpoints, risk controls, statistics, monitoring and governance for AIRCHILL-CA.
Open CA CIP →Full Clinical Investigation Plan
Peri-EVT AIRCHILL design with hard protection against reperfusion delay and blinded 90-day mRS evaluation.
Open stroke CIP →Schedule of Assessments + CRFs
Visit matrix, eCRF modules, source-data fields, timestamps, device exposure, neurological outcomes and health economics.
Open SoA / CRF →DSMB Charter
Membership, independence, review cadence, stopping domains, closed/open sessions, recommendations and documentation.
Open DSMB Charter →Statistical Analysis Plan
Estimands, ITT and safety sets, models, missing data, multiplicity, interim analysis, sensitivity analyses and subgroup governance.
Open SAP →Screening, enrolment & monitoring
Screening log, site qualification, monitoring strategy, risk-based SDV/SDR, deviations, training and recruitment dashboards.
Open operations plan →AE / SAE / Device Deficiency Plan
Definitions, causality, seriousness, reporting clocks, device deficiencies, unanticipated effects and escalation pathways.
Open safety plan →Investigator’s Brochure Framework
Device description, prior investigations, risk analysis, non-clinical evidence, instructions for use, accountability and emergency procedures.
Open IB framework →EU + FDA Submission Package
MDR Article 62/Annex XV dossier map, ethics package, FDA Pre-Sub/IDE structure, PreSTAR/eSTAR pathway and gap register.
Open regulatory package →Detailed pivotal-trial cost model
Lean/base/high bottom-up budget, per-patient economics and comparison with TTM2, PRINCESS, PRINCESS2, EuroHYP-1, COTTIS-2/CUCUMBER and published complex-device cost benchmarks.
Open cost benchmark model →24-month pivotal trial model
Source-backed budget and RTW/device requirement for the ~2,300-patient cardiac-arrest pivotal trial.
Open budget / RTW model →