Trial documents

Information sheets and consent forms

• Eligibility checklist and enrolment form TICH-3 Final v1.1 25.04.2024.docx
• Participant Full Consent Form -TICH-3 - Final v1.0 - 03.11.2021.docx
• Participant Information Sheet - TICH-3 - Final v1.0 - 03.11.2021.docx
• Participant Short Information Sheet - TICH-3 - Final v1.0 - 03.11.2021.docx
• Professional (Legal Rep) Full Consent Form - TICH-3 - Final v1.0 - 03.11.2021.docx
• Professional (Legal Rep) Information Sheet - TICH-3 - Final v1.0 - 03.11.2021.docx
• Professional (Legal Rep) Short Information Sheet and Consent TICH-3 - Final v1.0 - 03.11.2021.docx
• Relative (Legal Rep) Full Consent Form - TICH-3 - Final v1.0 - 03.11.2021.docx
• Relative (Legal Rep) Information Sheet TICH-3 Final v1.0 - 03.11.2021.docx
• Relative (Legal Rep) Short Information TICH-3 Final v1.0 - 03.11.2021.docx
• GP letter Final v1.0 - 03.11.2021.docx

Approved protocol

• Protocol Final v3.1 25.04.2024.pdf

Trial documents

• Eligibility checklist TICH-3 (OPTIONAL DOCUMENT) - Final v2.1 08.07.2024.docx   (updated 18 days ago)
• Co-enrolment Log - UoN and externally sponsored trials permitted for co-enrolment v3.1 08.02.2024.pdf
• Contact Sheet updated 07.12.2022.pdf
• File Note v1.1 05.12.20222.docx
• Site File Index v1.0 20.10.21.pdf
• Poster for ED v2.1 15.08.2023 (footer version corrected).pdf

UK site training

• CT Scan image training Final v1.0 13.09.2023.pdf
• CT scan upload training Final v1.2 08.03.2024.pdf
• Data corrections guidance Final v1.0 07.03.2023.pdf
• Enrolling Investigator Training Final v3.0 23.04.2024.pdf
• Haematoma volume Measurement Guidance Final v2.0 27.10.2022.pdf
• Investigator Training Final v4.0 23.04.2024.pdf
• Pharmacy Training Final 3.0 23.04.2024.pdf
• Ward Training Final v2.0 23.04.2024.pdf
• Seizures eligibility flowchart Final v1.0 24.01.2023.pdf

Pharmacy documents

• Assessment and monitoring of remote IMP storage Final v1.0 20.12.2021.docx
• IMP Accountability log Final v1.0 07.12.2021.docx
• IMP Check Final v1.0 20.12.2021.docx
• IMPD Final v2.0 09.03.2022.pdf
• IMP Inventory Log Final v1.0 20.12.2021.docx
• Information for Pharmacy Final v1.0 20.12.2021.pdf
• Prescribing and administration guide Final v2.0 01.02.2023.pdf
• Treatment packs specification.pdf

Sponsor documents

• RF1 TA008 Attendance Investigator Training TICH-3 Final v1.2.doc
• Evidence of Cover Clinical Trials Insurance 01.08.2023 - 31.07.2024.pdf
• SOP TA011 Participant Recruitment and Consent V1.5.pdf
• SOP TA014 SAE Reporting V4.0.pdf
• SOP TA015 Trial closure V4.0.pdf
• Sponsorship Statement 19.08.21.pdf

REC documents

• GCP Certificate Sprigg 22.01.2022.pdf
• HRA 297457 21.EM.0243 Favourable Opinion on further information 17.11.2021.pdf
• HRA IRAS297457 Letter of HRA Approval 18.11.2021.pdf
• NS Curriculum Vitae Template Short Nov 9 2021.pdf

MHRA documents

• Focus Tranexamic Acid 100mg ml Solution for Injection Summary of Product Characteristics (SmPC) 20210202 REVISION.pdf
• MHRA CTA Acceptance of Amended Request 20211103.pdf
• Sodium Chloride Injection BP 0.9 percent w v Summary of Product Characteristics (SmPC).pdf

SWAT substudy

• SWAT Consent video access site specific QR codes template Final v1.0 28.11.2023.docx
• SWAT Training - ONLY FOR UK Sites randomised into enhanced consent process Final v1.2 11.12.2023.pdf

Substantial amendments

• SA-06-24 /
• SA-05-23 /
• SA-04-22 /
• SA-03-22 /
• SA-02-22 /
• SA-01-21 /

Minor amendments

• MA-28-24 /   (updated 1 day ago)
• MA-27-24 /   (updated 2 days ago)
• MA-26-24 /
• MA-25-24 /
• MA-24-24 /
• MA-23-24 /
• MA-22-23 /
• MA-21-23 /
• MA-20-23 /
• MA-19-23 /
• MA-18-23 /
• MA-17-23 /
• MA-16-23 /
• MA-15-23 /
• MA-14-23 /
• MA-13-23 /
• MA-12-22 /
• MA-11-22 /
• MA-10-22 /
• MA-09-22 /
• MA-08-22 /
• MA-07-22 /
• MA-06-22 /
• MA-05-22 /
• MA-04-22 /
• MA-03-22 /
• MA-02-22 /
• MA-01-22 /

Trial working practice documents

• WPD 004 Preparing Trial Documentation v2.0 30.03.2022.pdf
• WPD 005 Consent Process v1.0 07.04.22.pdf
• WPD 006 Emergency Unblinding Procedure v1.0 07.04.22.pdf
• WPD 007 Broken Vials v1.0 07.04.22.pdf
• WPD 008 Destruction of IMP v1.0 07.04.22.pdf
• WPD 009 Entry of Missing Data v1.0 07.04.22.pdf
• WPD 010 SAE Reporting v1.0 07.04.22.pdf
• WPD 011 TICH-3 Uploading Scans v1.0 07.04.22.pdf

Newsletters

• Newsflash 31.03.21.pdf
• Newsletter Issue 1 31.05.2022.pdf
• Newsletter Issue 2 28.07.2022.pdf
• Newsletter Issue 3 20.01.2023.pdf
• Newsletter Issue 4 03.03.2023.pdf
• Newsletter Issue 5 06.04.2023.pdf
• Newsletter Issue 6 13.07.2023.pdf
• Newsletter Issue 7 23.08.2023.pdf
• Newsletter Issue 8 27.10.2023.pdf
• Newsletter Issue 9 20.12.2023.pdf
• Newsletter Issue 10 20.03.2024.pdf

Presentations

• ICTMC 2022 poster. Delays experienced in in setting up new clinical trials post COVID. Final v3 28.09.2022.pdf
• Nottingham BRC 2022 Poster. Effectiveness of a simple recruitment animation SWAT 17.11.2022.pdf

Investigator meetings

• Investigator Meeting with Q and As 2022.08.11.pdf
• Investigator Meeting with Q and As 2022.09.13.pdf
• Investigator Meeting with Q and As 2022.10.12.pdf
• Investigator Meeting with Q and As 2022.11.22.pdf
• Investigator Meeting with Q and As 2023.01.24.pdf
• Investigator Meeting with Q and As 2023.03.21.pdf
• Investigator Meeting with Q and As 2023.07.19.pdf
• Investigator Meeting with Q and As 2023.09.13.pdf
• Investigator meeting with Q and As 2023.11.22.pdf
• Investigator meeting with Q and As 2024.01.25.pdf
• Update Meeting (all sites) with Q and As 2024.04.17.pdf

International documents

• International EU Protocol 20230330 V4.2 - signed.pdf

International countries

• Switzerland /
• Denmark /
• Spain /
• Finland /
• France /
• Georgia /
• Republic of Ireland /
• Italy /
• Malaysia /
• Norway /
• Sweden /

Videos

• ED introduction 20220404 v1.mp4

• Enrolment v1.10
• Day 7 follow-up v1.7
• Discharge or death in hospital v1.0
• Serious Adverse Event v1.2   (see also list of sub-categories)
• Protocol violation v1.2
• Site-to-site transfer v1.0
• Data correction request v1.0