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CVD-Cog trial

CerebroVascular Disease - Cognition

Trial documents

Emergency numbers

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Approved protocol

PROTOCOL Clean 20250725 v 1.1 FINAL.pdf

Expression of interest

Synopsis and EOI 20250401 v2.0.docx

Trial documents

» Please click here to view superseded documents

Site training

» Please click here to view superseded documents (updated 22 days ago)

FAQs 20260330.pdf
Pharmacy SIV 20260331 v1.2.pdf
SIV 20260416 v2.1 pdf.pdf (updated 22 days ago)

Information sheets and consent forms

Pharmacy documents

» Please click here to view superseded documents

Sponsor
documents

» Please click here to view superseded documents (updated 13 days ago)

Evidence of Cover Clinical Trials 20250801 - 20260731.pdf (updated 29 days ago)
RF1 CT19 CTIMP SAE Report Form v1.0 26 Mar 2026.pdf (updated 13 days ago)
RF2 CT12 ISF Contents v1.0 25 Mar 2026.pdf (updated 13 days ago)
RF3 CT12 File Note v1.0 25 Mar 2026.docx (updated 1 day ago)
RF4 CT15 Trial Location Delegation Log v1.0 25 Mar 2026.docx (updated 7 days ago)
RF6 CT15 Trial Location Training Log v1.0 25 Mar 2025.docx (updated 8 days ago)
RF8 CT15 Screening and Enrolment Log v1.0 25 Mar 2025.pdf (updated 13 days ago)
RF9 CT15 Participant Identification Log v1.0 25 Mar 2026.pdf (updated 13 days ago)
SOP CT19 CTIMP Safety Reporting v1.0 26 Mar 2026 - signed.pdf (updated 13 days ago)
SOP CT22 Urgent Safety Measures v1.0 26 Mar 2026 - signed.pdf (updated 13 days ago)
SOP TA011 ParticipantRecruitConsent V1.5.pdf
SOP TA015 Trial closure V4.0.pdf

REC documents

» Please click here to view superseded documents (updated 24 days ago)

1011543 Letter of HRA Approval 20250819.pdf
CV Philip Bath 20260217.pdf (updated 24 days ago)
GCP E6(R3) Philip Bath Certificate of completion 20260419.pdf (updated 24 days ago)
REC Approval 1011543 25WM0144 Favourable opinion on further information 20250825.pdf

MHRA documents

Minor amendments

Trial working practice documents

WPD 001 Screening and Enrolment Log 20260114 v1.0.pdf (updated 2 days ago)
WPD 002 Consent 20260114 v1.0.pdf (updated 2 days ago)
WPD 003 Manual Randomisation 20260114 v1.0.pdf (updated 2 days ago)
WPD 005 Manual CRFs and SAEs 20260304 v1.0.pdf (updated 2 days ago)
WPD 006 Central Follow-Ups 20260408 v1.0.pdf (updated 1 day ago)
WPD 007 Protocol Deviations and Violations 20260303 v1.0.pdf (updated 2 days ago)
WPD 008 Entering missing data data queries and corrections 20260312 v1.0.pdf (updated 2 days ago)
WPD 009 Document Prep and Upload 20260114 v1.0.pdf (updated 1 day ago)
WPD 010 Secure Vault Uploads 20260114 v1.0.pdf (updated 1 day ago)
WPD 011 Baseline Cognitive Assessments 20260417 v1.0.pdf (updated 1 day ago)
WPD 012 Randomisation on Database 20260417v1.0.pdf (updated 1 day ago)
WPD 013 Serious Adverse Event Reporting 20260303 v1.0.pdf (updated 1 day ago)

Newsletters

Newsflash20250625.pdf
Newsflash20251008.pdf
Newsletter 202602.pdf
Newsletter 202603.pdf (updated 29 days ago)
Newsletter 202604.pdf (updated 13 days ago)

Printable CRFs

(updated 1.8 years ago)

Randomisation v1.0
Baseline v1.0
IQCODE baseline v1.0
Week 1-2 follow-up v1.0
Week 3-4 follow-up v1.0
Discharge or death in hospital v1.0
Prescription issue v1.0
No set visit v1.0
Outcome v1.0
Serious Adverse Event v1.0
(see also list of sub-categories)
Data correction request v1.0

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