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PhEAST site
PhEAST trial –
Ph
aryngeal
E
lectrical Stimulation for
A
cute
S
troke dysphagia
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rial
Trial documents
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Approved protocol
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Appendix L Austrian Consent Procedure V1.0 20220224.pdf
Protocol Appendix M Cognition Sub Study Scales V2.0 20221219 clean.pdf
Protocol Appendix N IQCODE v 1.0 20220617.pdf
Protocol V10.0 20240508 Clean.pdf
Protocol Appendix A Dysphagia Severity rating Scale v1.0 20210930.pdf
Protocol Appendix B Functional oral intake scale (FOIS) v1.0 20210930.pdf
Protocol Appendix C EAT-10 v1.0 20210930.pdf
Protocol Appendix D Feeding status scale (FSS) v1.0 20210930.pdf
Protocol Appendix E NIHSS v1.0 20210930.pdf
Protocol Appendix F GCS v1.0 20210930.pdf
Protocol Appendix G EuroQoL EQ-5D5L v1.0 20210930.pdf
Protocol Appendix H mRs v1.0 20210930.pdf
Protocol Appendix I Barthel Index v1.0 20210930.pdf
Protocol Appendix J TICS-M v1.0 20210930.pdf
Protocol Appendix K short ZDS v1.0 20210930.pdf
Expression of interest
Blank EOI Form.pdf
Trial documents
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(updated 17 days ago)
21068 Sponsor Letter ENGLISH REC.pdf
21068 Sponsor letter SCOTTISH REC.pdf
A1 - Trial Development Document File Note 20220214.pdf
Aphasia Friendly Participant Information on PES Treatment v1.0 20240416.pdf
Awareness Poster v2.0 20240508.pdf
(updated 17 days ago)
B.3 - RF1 TA011ParticipantScreeningEnrolmentLog.doc
Biological Materials B7 File Note V1.0 20220218.pdf
Cognition Subscales Visual Resource V1.0 20230420.docx
Communication Aid For Use During PES Treatment v1.0 20240416 (1).pdf
DMC Charter - Signed.pdf
(updated 24 days ago)
EAT 10 Visual resource V1.0 20230420.docx
EQ5D5L Visual Resource V1.0 20230420.docx
File Note - Database Build Paper V1.0 20220317.pdf
File Note A4 Site File - Delegation logs - 20220531.pdf
File Note Template V1.0 20220218.docx
IRASForm 304658 approved 20211004.pdf
Investigator Site File Index 20240522 V9.0.docx
PES Treatment Guide for Participants 20240530.pdf
Professor Philip Bath CV 20230104.pdf
RF1 TA013 Trial Amendment Log.doc
Randomisation and blinding File Note V2.0 20220426.pdf
Site File front sheet.pdf
Site Monitoring Visit Log V2.0 20221229.docx
Study SoECAT CRN Final Reauthorised V3.0 20230613.pdf
TSC Charter - Signed.pdf
(updated 24 days ago)
Treatment Tick-List for Participant v1.0 20240416 (1).pdf
Trial Contact Sheet V3.0 20240404.docx
Version Control Table - Scotland V7.0 20240604.docx
Version Control Table England Wales and NI V7.0 20240604.docx
Trial Manual V6.0 20231212.pdf
UK site training
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A.4 - SOP TA008 Trial InitiationV3.5 (1).pdf
Attendance at investigator training file note V1.0 20220427.pdf
FAQs V7.0 20240820.pdf
SIV Slides v9.0 20240606.pdf
RF1 TA008 Attendance Investigator Training PhEAST Final v1.0 (1).docx
Information sheets and consent forms
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(Scot) Participant Recovered Capacity (re-consent) PIS v4.0 20230307 clean.docx
(Scot) Participant consent final V4.0 20230307 clean.docx
(Scot) long PIS V6.0 20230307 clean.docx
Aphasia Friendly PIS and ICF (Scot) V2.0 20221027 clean.docx
Aphasia Friendly PIS and ICF V2.0 20220809 clean.docx
Consultee Declaration Form V4.0 clean 20230328.docx
Consultee PIS Final V6.0 clean 20230328.docx
Consultee Tel Declaration Form Final V3.0 20220513 clean.docx
GP letter (Scotland) V3.0 20221027.docx
GP letter Final V3.0 20220513 clean.docx
Informant Consent Form V3.0 20221219 clean.docx
Informant Information Sheet v1.0 20220624 clean.docx
Informant Tel Consent Form England and Wales V3.0 20221912 clean.docx
Participant Re-consent Final V3.0 20220513 clean.docx
Participant consent Final V3.0 20220513 clean.docx
Scotland Informant (WA.WG.NR) Consent Form Final V2.0 20230307 clean.docx
Scotland Informant (WA.WG.NR) Information Sheet Final v1.020220624 clean.docx
Scotland Informant (WA.WG.NR) Tel Consent Form V2.0 20230307 clean.docx
Scotland Legal Rep (WA.WG.NR) Consent Form Final v5.0 20230307 clean.docx
Scotland Legal Rep (WA.WG.NR) Tel Consent Form V5.0 20230307 clean.docx
Scotland Legal rep (WA.WG.NR) Information Sheet Final V 6.0 20230307 clean.docx
Scotland Participant Recovered Capacity Re-consent Final v5.0 20230307 clean.docx
Long PIS Final V4.0 20220809 clean.docx
Device documents
Supplies Log V1.0 20220308.docx
Sponsor documents
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EOC Clinical Trials.pdf
REC documents
07.01.2022 304658 21-0252 Letter of HRA Approval.pdf
21-SS-0075-Favourable Opinion On Further Information Letter 09-02-2022.pdf
304568 21 EE 0252 Favourable opinion-1.pdf
Substantial amendments
SA-10-24
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SA-09-23
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SA-08-23
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SA-07-23
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SA-06-22
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SA-05-22
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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-01-22
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Minor amendments
MA-27-24
/
(updated 12 days ago)
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-12-23
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MA-11-23
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MA-09-23
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MA-08-23
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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 001 Screening and Enrolment Log 20230518 V1.1.pdf
WPD 002 Consent 20230518 V1.1.pdf
WPD 005 Trial Monitoring 20230518 V2.1.pdf
WPD 008 Blinding 20230518 V1.1.pdf
WPD 009 Document Preparation V1.0 20221028.pdf
WPD 010 Secure Vault Uploads 20230518 V1.1.pdf
WPD 012 Randomisation 20230518 V1.1.pdf
WPD Log V7.0 20230928.pdf
WPD 003 PhEAST Manual Randomisation V1.0 20220216.pdf
WPD 004 PhEAST Decontamination of Equipment V1.0 20220216.pdf
WPD 011 PhEAST Cognition Sub-study V1.0 20220208 (1).pdf
WPD 013 PhEAST SAE Reporting 20230928.pdf
Newsletters
Newsletter - August 2024.pdf
Newsletter April 2023.pdf
Newsletter August 2022.pdf
Newsletter August 2023.pdf
Newsletter December 2022.pdf
Newsletter February 2023.pdf
Newsletter Jan 2024.pdf
Newsletter January 2023.pdf
Newsletter July 2022.pdf
Newsletter July 2023.pdf
Newsletter July 2024.pdf
Newsletter June 2022.pdf
Newsletter June 2023.pdf
Newsletter June 2024.pdf
Newsletter March 2023.pdf
Newsletter May 2023.pdf
Newsletter November 2022.pdf
Newsletter Oct-Nov 2023.pdf
Newsletter October 2022.pdf
Newsletter September 2022.pdf
Newsletter September 2023.pdf
Newsletter September 2024.pdf
Investigator meetings
Investigator Meeting-20230815.mp4
Investigator Meeting-20230911 123211-Meeting Recording.mp4
Investigator Meeting 20220623.mp4
Investigator Meeting 20220903.mp4
Investigator Meeting 20221207.mp4
Investigator Meeting 20230316.mp4
Investigator Meeting 20230426.mp4
Investigator Meeting 20230620.mp4
Investigator Meeting 20230719.mp4
Investigator Meeting Dysphagia Rehabilitation and Pharyngeal Electrical Stimulation 20230518.mp4
Printable CRFs
See also:
list of recent changes
.
(updated 261 days ago)
Eligibility
v1.4
Day 000
v1.3
Day 000 clinical
v1.6
Day 000 EQ-5D-5L
v1.1
Day 000 IQCODE
v1.2
Day 000 cognition
v1.1
PES treatment 1
v1.3
PES treatment 2
v1.2
PES treatment 3
v1.2
PES treatment 4
v1.2
PES treatment 5
v1.2
PES treatment 6
v1.3
Day 014 primary outcome
v1.6
Day 014 EQ-5D-5L
v1.1
Day 014 IQCODE
v1.2
Day 014 cognition
v1.2
Discharge or died
v1.2
Discharge or died EQ-5D-5L
v1.1
SWAT
v1.2
Serious Adverse Event
v1.4
SAE adjudication
v1.4
Device deficiency
v1.2
Protocol violation
v1.1
Protocol deviation
v1.0
Withdrawal
v1.0
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