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TICH-3 site
TICH-3 trial
T
ranexamic acid for
I
ntra
C
erebral
H
aemorrhage
3
Trial documents
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Information sheets and consent forms
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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
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Protocol Final v3.1 25.04.2024.pdf
Trial documents
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Eligibility checklist TICH-3 (OPTIONAL DOCUMENT) - Final v2.1 08.07.2024.docx
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
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(updated 30 days ago)
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
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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
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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
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(updated 25 days ago)
SWAT Consent video access site specific QR codes template Final v1.1 08.08.2024.docx
(updated 25 days ago)
SWAT Training - ONLY FOR UK Sites randomised into enhanced consent process Final v1.4 08.08.2024.pdf
(updated 25 days ago)
Substantial amendments
SA-06-24
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SA-05-23
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SA-04-22
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SA-03-22
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SA-02-22
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SA-01-21
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Minor amendments
MA-29-24
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(updated 16 days ago)
MA-28-24
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MA-27-24
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MA-26-24
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MA-25-24
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MA-24-24
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MA-23-24
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MA-22-23
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MA-21-23
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MA-20-23
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MA-19-23
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MA-18-23
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MA-17-23
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MA-16-23
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MA-15-23
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MA-14-23
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MA-13-23
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MA-12-22
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MA-11-22
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MA-10-22
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MA-09-22
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MA-08-22
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MA-07-22
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MA-06-22
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MA-05-22
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MA-04-22
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MA-03-22
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MA-02-22
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MA-01-22
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Trial working practice documents
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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
(updated 26 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 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
/
France
/
(updated 24 days ago)
Georgia
/
(updated 4 days ago)
Republic of Ireland
/
(updated 4 days ago)
Italy
/
Malaysia
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Norway
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Sweden
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Videos
ED introduction 20220404 v1.mp4
Printable CRFs
See also:
list of recent changes
.
(updated 37 days ago)
Enrolment
v1.11
Day 7 follow-up
v1.8
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
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