Study Resources
Key Study Materials
Subject-Related Documents
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Adverse Events Log V1.0 Final 27May2025
ConMeds log V1.0 Final 02Jun2025
ConProcedures Log V1.0 Final 27May2025
Eligibility Checklist V1.0 Final 27May2025
Medical History V1.0 Final 27May2025
Ophthalmic Assessments Source V1.0 Final_03Jun2025
Ophthalmic History V1.0 Final 27May2025
Physical Examination V1.0 Final 02Jun2025
PredForte Vs Placebo Administration Log V1.0 27May2025
Tacrolimus vs Placebo Administration Log V1.0 Final 29May2025
Tacrolimus Whole Blood Trough Level V1.0 Final 27May2025
Visit Flow Sheet Day 1 - Day 60 V1.0 Final 02Jun2025
Visit Flow Sheet for Lab Visits V1.0 Final 02Jun2025
Visit Flow Sheet Implantation Day - Sham V1.0 Final 02Jun2025
Visit Flow Sheet Post Day 60 V1.0 Final 02Jun2025
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Protocol Signature Page 01Dec2024
Data Privacy and Personal Information Notice for Clinical Site Personnel V1.0 15Aug2024
Site-Specific Recruitment Plan V1.1 15Jan2025
Financial Disclosure Form V1.0 05Aug2024
Site Equipment Inventory Template V1.0 13Aug2024
Site Signature and Delegation Log (SSDL) V1.0 05Aug2024
Source Document Location Form (SDL) V 1.0 02Jan2025
Site Specific Contact List and Access Request V1.0 14Jan2025
Safety
Manuals
Correspondence
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To be added as needed.
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Study Training
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Master CPCB-RPE1 Inventory and Accountability log V1.0 Final 19May2025
Master Moxifloxacin Drug Inventory and Accountability log V1.0 Final 20May2025
Master PredForte Drug Inventory and Accountability log V1.0 Final 20May2025
Master PredForte Drug Inventory and Accountability log V1.1 Final_26Aug2025
Master PredForte Placebo Drug Inventory and Accountability log V1.0 Final 20May2025
Master PredForte Placebo Drug Inventory and Accountability log V1.1 Final_26Aug2025
Master SIDD Inventory and Accountability log V1.0 Final 20May2025
Master SIDD Trocar Cannula and Plug Inventory and Accountability log V1.0 Final 20May2025
Master Side Gripping Forceps Inventory and Accountability log V1.0 Final 20May2025
Master Subretinal Irrigating Cannula Inventory and Accountability log V1.0 Final 20May2025
Master Tacrolimus Drug Inventory and Accountability log V1.0 Final 20May2025
Master Tacrolimus Placebo Drug Inventory and Accountability log V1.0 Final 20May2025
Paradyne Order Request Form V1.0 Final 06Jun2025
IP Temperature Excursion Form V1.0 Final 21Aug2024
IP Temperature Excursion Form V1.1 Final_25Aug2025
Temperature Monitoring Log Ancillary Drug V1.0 Final 03Sep24
Paradyne Order Request Form V1.1 Final 14Jul2025
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Coming soon