Regulate-RA Trial
Trial Therapy
Rheumatoid Arthritis (RA)
About Clinical Research
Trial Clinic Locations
For Participating Sites
HCP and Patient Materials
Please click below to view and download study related materials.
HCP Materials
VAS Assessment - Patient
VAS Assessment - Physician
FACIT-F
HAQ-DI
HAQ-DI Scoring Sheet
Appointment Reminder Card
Participant Emergency Contact Card
Participant Thank You Card
Subject Eligibility Forms (combined PDF)
Pre-Screening Slot Request Form
28SJC/28TJC Joint Assessment Form
66JC/68TJC Joint Assessment Form
Pre-Screening Checklist
Schedule of Assessments (Baseline – Safety Follow-Up)
Schedule of Assessments (Screening – Pretreatment)
PCS - Site Payment Initiation Guide
PCS - Site Portal User Guide
PCS - Site Portal Training Guide
ISF Binder
1. Table of Contents
2. Study Team List
3. ClinTrak Arm Site Instructions
4. Study Supplies Request Template
5. Protocol
6. Investigator's Brochure
7. IP Manual
8. IP Preparation & Administration Form
9. IP Disposal and Destruction Form
10. Site Signature and Responsibility Log
11. Site Personnel Training Log
12. SMC Charter
13. Exposure in Utero Form
14. Back-up SAE Form
15. Site Visit Log Form
16. Lab Manual
17. Laboratory Quick Reference Chart
18. Laboratory Re-Supply Form
19. eCRF Completion Guidelines
20. Study Operations Manual
21. Apheresis Collection Protocol
22. Synovial Biopsy Manual
23. MRI Manual
Patient Materials & Diaries
Enhanced Brochure
Participant Handbook
Participant Journey
Patient Intro to CAR-T Regulatory Cell Infusion White Paper
Trial Participant Companion Reminder
Participant Diary Week 1
Participant Diary Week 2
Participant Diary Week 3
Participant Diary Week 4
Participant Diary Week 5-6
Participant Diary Week 7-8
Participant Diary Week 9-10
Participant Diary Week 11-12
Participant Diary Week 13-18
Participant Diary Week 19-24
Participant Diary Week 25-36
Participant Diary Week 37-48
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