MAPS-2 trial – Metoclopramide for Avoiding Pneumonia after Stroke 2

Trial documents

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Approved protocol	» Please click here to view superseded documents Research Protocol v 2.0 20240702 - clean.pdf

Trial documents	Awareness Poster 20240603 v3.0.pdf Eligibility Checklist v1.0 20230427.pdf File Note Template.docx Transfer Form 20221124 v1.0.pdf Treatment Administration Instructions 20220506 v1.0.docx Trial Contact Sheet - updated 27.08.2024.pdf UKCRN letter of Portfolio acceptance 13.10.21.pdf

Site training	» Please click here to view superseded documents Blank Training Log.doc SIV Training Slides 20240902 V9.0.pdf

Videos	Alternative IMP Delivery 20220104 v1.0.mp4 Metoclompramide NG Administration 20220104 v1.0.mp4 REDCap Demo 20211118 v1.0.mp4

Information sheets and consent forms	GP letter Final including ref nos. 20210611 v1.0.docx Legal Representative Consent Form Final v1.0 20211108.docx Legal Representative Information Sheet Final v1.0 20211108.docx Legal Representative Information and Consent Form Final v1.0 20211108.docx Legal Representative Telephone Consent Form Final v1.0 20211108.docx Participant Consent Form Final v1.0 20211108.docx Participant Information Sheet Final v1.0 20211108.docx Participant Information and Consent Form Final v1.0 20211108.docx Participant Re-consent Final 1.0 20211108.docx

Pharmacy documents	Metoclopramide 5 mg ml Injection - Summary of Product Characteristics (SmPC) - print friendly - (emc).pdf

Sponsor documents	» Please click here to view superseded documents Evidence of Cover Clinical Trials Insurance 01.08.2024 - 31.07.2025.pdf SOP TA008 Trial Initiation 20190128 V3.5.pdf SOP TA010 TMF TSF 20180205 V2.0.pdf SOP TA016 SeriousGCPBreachReporting 20180112 V1.5.pdf

REC documents	(290474) 21.EM.0246 Favourable Opinion on further information 20211117.pdf

MHRA documents	CTA Acknowledgement Administration Letter SA01 20230802.pdf CTA Notice of Acceptance 20211022.pdf Cover Letter MHRA signed CR 190821.docx IRAS290474 Letter of HRA Approval 20211117.pdf

Substantial amendments	» SA-03-24 /

Minor amendments	MA-21-24 / MA-20-24 / MA-19-24 / MA-18-24 / MA-17-24 / MA-16-23 / MA-15-23 / MA-14-23 / MA-13-23 / MA-12-23 / MA-11-23 / 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-01-21 /

Trial working practice documents	221012 MAPS-2 Consent hierarchy flow chart.pdf Database access WPD 20220421 v1.0.pdf

Newsletters	Newsflash2 MARCH 2023 recruitment window changed to 24 hours.pdf Newsflash MARCH 2023 who can prescribe.pdf Newsletter - AUG 2022.pdf Newsletter - FEBRUARY 2023.pdf Newsletter - JUNE 2022.pdf Newsletter APRIL 2024.pdf.pdf Newsletter December 2024.pdf (updated 5 days ago) Newsletter JULY 2024.pdf Newsletter JUNE 2024.pdf Newsletter May 2024.pdf.pdf Newsletter November 2024.pdf (updated 5 days ago) Newsletter OCTOBER 2024.pdf

Investigator meetings	Investigator Meeting 20240628.pdf Investigator Meeting 20240924.pdf Investigator Meeting Slides 20240726.pdf


Printable CRFs	(updated 186 days ago) Randomisation v1.5 Daily clinical monitoring log v1.2 Results of cultures v1.1 Antibiotic treatment v1.1 Day 14 follow-up v2.3 Pneumonia diagnosis v1.1 Discharge to the community v1.1 Vital status v1.1 Serious Adverse Event v1.4 Protocol violation v1.2 Withdrawal notification v1.0 Site-to-site transfer v1.1 Please log in to download a zip archive of printable CRFs from the supporting site. Participant contact details should be submitted directly online. A printable preview of the contact details form is available here.
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