Trial documents

Approved protocol

• 01 - 1004870 MACE ICH Protocol Final v2.0 27Jul2023 Clean.pdf

Trial documents

• Co-enrolment Log for sites v1.0 20230201.pdf
• Contact sheet V1.0 20231010.pdf
• Eligibility Checklist V1.1 20231124.pdf
• FAQs V1.0 20240110.pdf
• File Note A1 - Trial Development Documents 20231009.pdf
• File Note A3 - Funding letter 20231106.pdf
• File Note A3 - Sponsorship Statement 20231106.pdf
• File Note A4 Site File Delegation Log 20231009.pdf
• File Note A6 - Randomisation and blinding 20231009.pdf
• File Note A7 Database Build 20231012.pdf
• File Note Template V1.1 20240112.docx
• ISF Trial Identifiers Front Sheet V1.0 20231010.pdf
• Medical Record Labels V1.0 20231115.docx
• Site File Index V1.0 20231115.pdf
• Site Visit Log V1.0 20231018.docx
• TAFR01501 Screening-Log V1.0 20231115.docx
• TAFR01502 Enrolment-Log V1.0 20231115.docx
• TAFR02404 Amendment summary log v3 19May2022.pdf

Site training

• Investigator Training Slides Final v4.1 20240612.pdf
• Pharmacy Training Slides Final v4.1 20240612.pdf
• TAFR01204 Training-Log V1.0 20231115.docx

Information sheets and consent forms

• 05 - 1004870 MACE-ICH Legal Representative Information Sheet v2.0 27Jul2023 Clean.docx
• 06 - 1004870 MACE-ICH Legal Representative Pictorial Information Sheet v2.0 27Jul2023 Clean.docx
• 03 - 1004870 MACE ICH PIS Final v2.0 27Jul2023 Clean.docx
• 04 - 1004870 MACE ICH Participant Pictorial Info Sheet v2.0 27Jul2023 Clean.docx
• 07 - 1004870 MACE ICH ICF Final v2.0 27Jul2023 Clean.docx
• 08 - 1004870 MACE ICH Legal Rep Consent Form v2.0 27Jul2023 Clean.docx
• 09 - 1004870 MACE ICH GP letter v1.0 17May2022.docx

Pharmacy documents

• 14 - 100870 MACE ICH Pharmacy Manual v1.1 20231214 Cln Signed.pdf
• 15 - Mannitol 10 percent Solution for Infusion BP - Summary of Product Characteristics (SmPC).pdf
• Appendix 1 - Clinical trials transfer request form v1.0 20231108.pdf
• Appendix 2 - IMP site inventory log v1.0 20231108.pdf
• Appendix 3 - Stroke Unit IMP accountability log v1.0 20231108.pdf
• Appendix 4 - Return of clinical trial supplies v1.0 20231108.pdf
• Appendix 5 - Record of IMP destruction v1.0 20231108.pdf
• Pharmacy File Index V1.1 20240123 Clean.doc

Sponsor documents

• File Note - Website link for Sponsor SOPs Updated 20240208.pdf
• Insurance Document 11Aug2022.pdf
• TAFR01705 Non-Compliance-Reporting-Form-V2 20230313.docx
• TAFR01911 SAE-Follow-Up-Report Version-3.docx
• TAFR01912 Serious Adverse Event Reporting Form (CTIMP and other) Version 2.docx

REC documents

• 17 - K. Krishnan cv 19012023.pdf
• 1004870 22-EM-0242 REC Approval 20230510.pdf
• 1004870 Letter of HRA Approval 20230510.pdf

MHRA documents

• MHRA CTA Acceptance of Amended Request 20230515.pdf

Substantial amendments

Minor amendments

• NSA-09-2024 /
• NSA-08-2024 /
• NSA-07-2024 /
• NSA-06-2024 /
• NSA-05-2024 /
• NSA-04-2024 /
• NSA-03-2024 /
• NSA-02-2024 /
• NSA-01-2023 /

Trial working practice documents

• WPD 001 Secure Vault Uploads V1.0 20231017.pdf
• WPD 002 Uploading Scans V1.0 20231017.pdf
• WPD 003 Manual Randomisation V1.0 20231012.pdf
• WPD 004 Site Monitoring V1.0 20231012.pdf
• WPD 005 Screening and Enrolment Logs V1.0 20231115.pdf
• WPD 006 Entry of Missing Data V1.0 20231018.pdf
• WPD 007 Consent Process V1.0 20231114.pdf
• WPD 008 MACE-ICH Protocol Deviations and Violations V1.0 20240126.pdf
• WPD 009 MACE-ICH Serious Adverse Event Reporting V1.0 20240126.pdf

• Randomisation v1.2
• Day 1 follow-up at 24 hours v1.3
• Day 2 follow-up at 48 hours v1.3
• Day 5 follow-up v1.2
• Day 28 follow-up v1.2
• Discharge or death in hospital v1.1
• Serious Adverse Event or outcome v1.2   (see also list of sub-categories)
• Protocol violation v1.0
• Site-to-site transfer v1.0
• Data correction request v1.0