US Clinical Trial
HiSQoL
HiSQOL Instructions for Use and Scoring
ISH4/HiSCR
NRS30
HCP Factsheet
Appointment Reminder Card
Participant Emergency Contact Card
Participant Thank You Card
Subject Eligibility Forms (combined PDF)
Pre-Screening Checklist
Schedule of Assessments (Baseline-Safety Follow-up)
Schedule of Assessments (Screening - Pretreatment)
Pre-Screening Slot Request Form
PCS - Site Payment Initiation Guide
PCS - Site Portal User Guide
PCS - Site Portal Training Guide
Enhanced Brochure
Participant Handbook
Participant Journey
Trial Participant Companion Reminder
Patient Intro to CAR-T Regulatory Cell Infusion White Paper
Week 1
Week 2
Week 3
Week 4
Weeks 5-6
Weeks 7-8
Weeks 9-10
Weeks 11-12
Weeks 13-18
Weeks 19-24
Weeks 25-36
Weeks 37-48
1. Table of Contents
2. Study Team List
3. Study Supplies Request Template
4. ClinTrak Access Request Management Site Instructions
5. Clinical Study Protocol
6. Investigator's Brochure
7. IP Manual
8. IP Preparation and Administration Form
9. IP Disposal and Destruction Form
10. Site Signature Responsibility Log
11. Site Personnel Training Log
12. Safety Monitoring Committee Charter
13. Exposure in Utero Form
14. Backup SAE Form
15. Site Visit Log Form
16. Lab Manual
17. Quick Reference Chart
18. Laboratory Re-Supply Form
19. eCRF Completion Guideline
20. Sonoma Apheresis Collection Protocol
21. Study Operations Manual
22. Skin Biopsy Manual