TICH-3 trial – Tranexamic acid for IntraCerebral Haemorrhage 3

Trial documents

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Information sheets and consent forms	» Please click here to view superseded documents Eligibility checklist and enrolment form TICH-3 Final v1.1 25.04.2024.docx Participant Full Consent Form -TICH-3 - Final v1.0 - 03.11.2021.docx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Approved protocol	» Please click here to view superseded documents Protocol Final v3.1 25.04.2024.pdf

Trial documents	» Please click here to view superseded documents (updated 27 days ago) Eligibility checklist TICH-3 (OPTIONAL DOCUMENT) - Final v2.1 08.07.2024.docx Clinic Poster Final v1.0 22.10.2024.pdf (updated 29 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 Final v2.2 22.10.2024.pdf (updated 29 days ago)

UK site training	» Please click here to view superseded documents CT Scan image training Final v1.0 13.09.2023.pdf CT scan upload training Final v1.2 08.03.2024.pdf Data corrections guidance Final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Pharmacy documents	» Please click here to view superseded documents Assessment and monitoring of remote IMP storage Final v1.0 20.12.2021.docx IMP Accountability log Final v1.0 07.12.2021.docx IMP Check Final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	» Please click here to view superseded documents RF1 TA008 Attendance Investigator Training TICH-3 Final v1.2.doc Evidence of Cover Clinical Trials Insurance 01.08.2024 - 31.07.2025.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	» Please click here to view superseded documents SWAT Consent video access site specific QR codes template Final v1.1 08.08.2024.docx SWAT Training - ONLY FOR UK Sites randomised into enhanced consent process Final v1.4 08.08.2024.pdf

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

Minor amendments	MA-29-24 / MA-28-24 / MA-27-24 / 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	» Please click here to view superseded 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 Newsletter Issue 11 28.05.2024.pdf Newsletter Issue 12 31.07.2024.pdf Newsletter Issue 13 04.11.2024.pdf (updated 16 days ago)

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 UK sites) with Q and As 2024.09.25.pdf Update Meeting (all sites) with Q and As 2024.04.17.pdf Update Meeting (all sites) with Q and As 2024.06.13.pdf

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

International countries	Switzerland / Denmark / Spain / Finland / (updated 8 days ago) France / Georgia / Republic of Ireland / Italy / Malaysia / Norway / Sweden /

Videos	ED introduction 20220404 v1.mp4


Printable CRFs	(updated 26 days ago) Enrolment v1.11 Day 7 follow-up v1.9 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 Please log in to download a zip archive of printable CRFs. Participant contact details should be submitted directly online. A printable preview of the contact details form is available here.
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