«
MACE-ICH site
MACE-ICH trial –
MA
nnitol for
C
erebral o
E
dema after
I
ntra
C
erebral
H
aemorrhage
Trial documents
Emergency numbers
This page does not provide the emergency mobile numbers.
Please
log in
to view them, or bookmark the main documents page instead of this one.
Approved protocol
01 - 1004870 MACE ICH Protocol Final v2.0 27Jul2023 Clean.pdf
Trial documents
» Please
click here
to view superseded documents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
» Please
click here
to view superseded documents
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
» Please
click here
to view superseded documents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
» Please
click here
to view superseded 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
»
SA-01-23
/
Minor amendments
NSA-09-2024
/
(updated 2 days ago)
NSA-08-2024
/
(updated 2 days ago)
NSA-07-2024
/
(updated 2 days ago)
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
Printable CRFs
See also:
list of recent changes
.
(updated 92 days ago)
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
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
.
To read PDF documents, you may need to install Acrobat Reader first.
Please
click here
if you require installation instructions.
Switch to mobile site