# AIRCHILL Clinical Investigation Package

> Operational AIRCHILL clinical investigation package linking the cardiac-arrest and stroke CIPs, Schedule of Assessments, CRF/data dictionary, DSMB Charter, SAP, monitoring, safety reporting, Investigator's Brochure frame…

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- Last modified: 2026-09-03T23:57:22+00:00

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

CIP · Cardiac arrest

### Full Clinical Investigation Plan

Objectives, design, population, intervention, schedule, endpoints, risk controls, statistics, monitoring and governance for AIRCHILL-CA.
[Open CA CIP →](https://www.medicalcooling.com/cip-airchill-cardiac-arrest/)

CIP · Stroke

### Full Clinical Investigation Plan

Peri-EVT AIRCHILL design with hard protection against reperfusion delay and blinded 90-day mRS evaluation.
[Open stroke CIP →](https://www.medicalcooling.com/cip-airchill-ischaemic-stroke/)

Data capture

### Schedule of Assessments + CRFs

Visit matrix, eCRF modules, source-data fields, timestamps, device exposure, neurological outcomes and health economics.
[Open SoA / CRF →](https://www.medicalcooling.com/airchill-schedule-of-assessments-crf/)

Independent oversight

### DSMB Charter

Membership, independence, review cadence, stopping domains, closed/open sessions, recommendations and documentation.
[Open DSMB Charter →](https://www.medicalcooling.com/airchill-dsmb-charter/)

Statistics

### Statistical Analysis Plan

Estimands, ITT and safety sets, models, missing data, multiplicity, interim analysis, sensitivity analyses and subgroup governance.
[Open SAP →](https://www.medicalcooling.com/airchill-statistical-analysis-plan/)

Study conduct

### Screening, enrolment & monitoring

Screening log, site qualification, monitoring strategy, risk-based SDV/SDR, deviations, training and recruitment dashboards.
[Open operations plan →](https://www.medicalcooling.com/airchill-screening-monitoring-plan/)

Safety

### AE / SAE / Device Deficiency Plan

Definitions, causality, seriousness, reporting clocks, device deficiencies, unanticipated effects and escalation pathways.
[Open safety plan →](https://www.medicalcooling.com/airchill-safety-reporting-plan/)

Device evidence

### Investigator’s Brochure Framework

Device description, prior investigations, risk analysis, non-clinical evidence, instructions for use, accountability and emergency procedures.
[Open IB framework →](https://www.medicalcooling.com/airchill-investigators-brochure-framework/)

Regulatory

### 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 →](https://www.medicalcooling.com/airchill-eu-fda-clinical-submission-package/)

US public data

### Clinical & Public Data Intelligence

CMS Medicare hospital utilisation/payments combined with ClinicalTrials.gov research-network signals, protocol-specific site qualification, TBI portfolio screening and source-governed health-economic modelling.
[Open US data intelligence →](https://www.medicalcooling.com/us-clinical-public-data-intelligence/)

Finance & benchmarks

### 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 →](https://www.medicalcooling.com/airchill-pivotal-trial-detailed-cost-model-benchmarks/)

Document-control rule. Before first regulatory use, every module must receive a sponsor document number, version, effective date, author/reviewer/approver signatures, controlled change history and cross-reference to the current device configuration and risk-management file.

Budget & EMS deployment

### 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 →](https://www.medicalcooling.com/airchill-cardiac-arrest-trial-budget-rtw-deployment/)

Document-control rule. Before first regulatory use, every module must receive a sponsor document number, version, effective date, author/reviewer/approver signatures, controlled change history and cross-reference to the current device configuration and risk-management file.