ReCAST-3 trial – Remote ischaemic Conditioning After Stroke Trial 3

Trial documents

Emergency numbers (printable)	For urgent medical enquiries (including unblinding), and for randomisation problems, you can contact the following emergency mobile numbers. 07810 540 604 07725 580 092 07798 670 726 Last updated: 23 September 2020

Approved protocol	» Please click here to view superseded documents RECAST-3 Protocol Final V5.0 20240507 Clean signed.pdf

Expression of interest	» Please click here to view superseded documents

Trial documents	» Please click here to view superseded documents (updated 10 days ago) File Note RECAST-3 Site Delegation Log 20211007.pdf RECAST-3 Co-enrolment Log for sites v2.0 20241018.pdf RECAST-3 Contact sheet V1.5 20240212.pdf RECAST-3 Eligibility Checklist V1.2 20241016.pdf RECAST-3 England GP letter Final v2.0 20230905 Cln.doc RECAST-3 Investigator Site File Index 20241211 V2.0.pdf (updated 10 days ago) RECAST-3 Medical Record Labels V1.0 20240216.docx RECAST-3 Medical notes treatment delivery label template v1.0 20240409.docx RECAST-3 Poster for staff only areas 20240524 v1.0.pdf RECAST-3 Scotland GP letter Final Version V2.0 20230905 Cln.doc RECAST-3 UKCRN Adoption Confirmation Email 20200325.pdf File Note ISF - A.1 Trial Development Documentation 20221118.pdf File Note TMF ISF - A.7 Database Build 20221118.pdf File Note TMF ISF A.6 Randomisation and Blinding 20221118.pdf File Note TMF ISF B.7 Biological Materials 20221118.pdf File Note Template 20211027 V1.2.docx Site Monitoring Visit Log 20211220 V1.0.docx File note - sub-study not curently being delivered 20240321.pdf

Site training	» Please click here to view superseded documents RECAST-3 AT4 Device training v1.0 20240617.pdf RECAST-3 FAQs V4.0 20241017.pdf RECAST-3 GCP for ward staff final version 1.2 20240416.mp4 RECAST-3 Investigator Training V3.1 20241107.pdf RECAST-3 SAE electronic review process local PI Final v1.0 20241216.pdf (updated 5 days ago) RECAST-3 Ward Staff Training Log 20240419 V1.1.docx RF1 TA008 Attendance Investigator Training RECAST-3 20231123 V1.0.doc AT4 Device Interface controls V1.0 20240318.mp4 AT4 Device Participant set up and treatment delivery V1.0 20240318.mp4 AT4 Device Pre treatment checks V1.0 20240318.mp4 AT4 Device Troubleshooting V1.0 20240318.mp4 Data Corrections Guidance 20230307 V1.0.pdf

Information sheets and consent forms	» Please click here to view superseded documents RECAST-3 England Consent form Final v3.0 20230905 Cln.docx RECAST-3 England Consultee Declaration Form v3.0 20230905 Cln.docx RECAST-3 England Consultee Information Sheet Final v3.1 20240507 Clean.docx RECAST-3 England PIS Re-consent Final V3.1 20240507 Clean.docx RECAST-3 England PIS V3.1 20240507 Clean.docx RECAST-3 Scotland Consent Form Final Version V3.0 20231130 Cln.docx RECAST-3 Scotland PIS Final Version V4.1 20240507 Clean.doc RECAST-3 Scotland PIS Re-consent Final Version V4.1 20240507 Clean.doc RECAST-3 Scotland Welfare Attorney Consent Form Final Version V3.0 20230905 Cln.docx RECAST-3 Scotland Welfare Attorney Information Sheet Final Version V4.1 20240507 Clean.doc RECAST-3 Telephone Consent Record V2.0 20230905 Cln.docx

Device documents	» Please click here to view superseded documents 995104 - Iss 01 - Product Training Guidance - AT4 Electronic Tourniquet - RECAST-3.pdf

Sponsor documents	» Please click here to view superseded documents Evidence of Cover Clinical Trials Insurance 01.08.2024 - 31.07.2025.pdf RF1 TA011 Participant Screening and Enrolment Log.doc RF2 TA008 Delegation Log and Codes (Ward Staff).doc SOP TA008 Trial Initiation 20190128 V3.5.pdf SOP TA010 TMF TSF 20180205 V2.0.pdf SOP TA016 Serious GCP Breach Reporting 20180112 V1.5.pdf Sponsorship Statement 20200310.pdf

REC documents	20-NW-0173 English REC Approval 20200527.pdf 20-SS-0047 Scottish REC Approval 20200611.pdf 277021 Letter of HRA Approval 20231204.pdf

MHRA documents	CI Professor Tim England CV Signed 20220608.pdf CI Professor Tim England GCP 20220831.pdf

Substantial amendments	SA-07-24 / SA-06-23 / SA-05-23 /

Minor amendments	MA-10-24 / (updated 7 days ago) MA-09-24 / (updated 7 days ago) MA-08-24 / MA-07-24 / MA-06-24 / MA-05-24 / MA-04-24 / MA-03-24 / MA-02-24 / MA-01-23 /

Trial working practice documents	» Please click here to view superseded documents RECAST-3 WPD Log Updated 20240418.pdf WPD 002 RECAST-3 Entry of Missing Data 20220923 V1.0.pdf WPD 007 RECAST-3 Manual Randomisation 20220923 V1.0.pdf WPD 010 RECAST-3 Site Closedown 20220923 V1.0.pdf WPD 001 RECAST-3 Screening and Enrolment Log 20240410 V2.0.pdf WPD 003 RECAST-3 Decontamination of RECAST-3 Equipment 20240410 V2.0.pdf WPD 004 RECAST-3 Uploading Images to the RECAST-3 Database 20240410 V2.0.pdf WPD 005 RECAST-3 Secure Vault Uploads - Site Process 20240410 V2.0.pdf WPD 006 RECAST-3 Event Reporting 20240410 V2.0.pdf WPD 008 RECAST-3 Protocol Deviations and Violations 20240410 V2.0.pdf WPD 009 RECAST-3 Site Monitoring 20240918 V2.1 Clean.pdf

Newsletters	Newsletter Issue 1 June 2021.pdf

Investigator meetings	RECAST-3 Site Investigator Meeting final v1.0 20240912.pdf RECAST-3 Site Investigator Meeting final v1.0 20241106.pdf RECAST-3 Site Investigator Meeting v1.0 20240516.pdf RECAST-3 Site Investigator Meeting v1.0 20240702 Final.pdf RECAST-3 UKSF 2024 Investigator Meeting Slides Final V1.0 20241129.pdf (updated 5 days ago)


Printable CRFs	(updated 283 days ago) Randomisation v2.1 Day 1 follow-up v2.0 Day 2 follow-up v2.0 Treatment log v1.0 End of treatment v1.0 Discharge or death in hospital v2.0 Serious Adverse Event v2.0 (see also list of sub-categories) Protocol violation v2.0 Site-to-site transfer v2.0 Data correction request v2.0 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.
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